A newborn is receiving phototherapy. which intervention by the nurse would be most important?

Cochrane Database Syst Rev. 2020; 2020(7): CD012011.

Abstract

Background

Phototherapy is a well‐established effective therapy for treating babies with significant neonatal jaundice. Studies have shown that increasing light intensity will increase its efficiency. A potentially inexpensive and easy way of increasing the intensity of light on the body of the infant may be to hang reflective materials from the sides of phototherapy units.

Objectives

To assess the effects of reflective materials in combination with phototherapy compared with phototherapy alone for unconjugated hyperbilirubinaemia in neonates.

Search methods

We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 11), in the Cochrane Library; Ovid MEDLINE(R) and Epub Ahead of Print, In‐Process & Other Non‐Indexed Citations, Daily and Versions(R); and the Cumulative Index of Nursing and Allied Health Literature (CINAHL), on 1 November 2019. We also searched clinical trials databases and the reference lists of retrieved articles for randomised controlled trials and quasi‐randomised trials.

Selection criteria

We included randomised and quasi‐randomised controlled trials if the participants, who were term or preterm infants, received phototherapy with curtains made of reflective materials of any type in the treatment arm, and if those in the comparison arm received similar phototherapy without curtains or other intensified phototherapy, such as a double bank of lights.

Data collection and analysis

We used standard methodological procedures expected by Cochrane. We used the GRADE approach to assess the certainty of evidence.

Main results

Of 15 studies identified, we included 12 (1288 babies) in the review ‐ 11 comparing phototherapy with reflective materials and phototherapy alone, and one comparing a single phototherapy light bank with reflective materials with double phototherapy. All reflective materials consisted of curtains on three or four sides of the cot and were made of white plastic (five studies), white linen (two studies), or aluminium (three studies); materials were not specified in two studies. Only 11 studies (10 comparing reflective materials versus none and one comparing reflective curtains and a single bank of lights with a double (above and below) phototherapy unit) provided sufficient data to be included in the meta‐analysis. Two excluded studies used the reflective materials in a way that did not meet our inclusion criteria, and we excluded one study because it compared four different phototherapy interventions not including reflective materials. The risk of bias of included studies was generally low, but all studies had high risk of performance bias due to lack of blinding of the intervention.

Three studies (281 participants) reported a decline in serum bilirubin (SB) (μmol/L) at four to eight hours (mean difference (MD) ‐14.61, 95% confidence interval (CI) ‐19.80 to ‐9.42; I² = 57%; moderate‐certainty evidence). Nine studies (893 participants) reported a decline in SB over 24 hours and showed a faster decline in SB in the intervention group, but heterogeneity (I² = 97%) was too substantial to permit a meaningful estimate of the actual effect size (very low‐certainty evidence). Subgroup analysis by type of reflective material used did not explain the heterogeneity. Exchange transfusion was reported by two studies; both reported none in either group. Four studies (466 participants) reported the mean duration of phototherapy, and in each of these studies, it was reduced in the intervention group but there was substantial heterogeneity (I² = 88%), precluding meaningful meta‐analysis of data. The only two studies that reported the mean duration of hospital stay in hours showed a meaningful reduction (MD ‐41.08, 95% CI ‐45.92 to ‐36.25; I² = 0; moderate‐certainty evidence).

No studies reported costs of the intervention, parental or medical staff satisfaction, breastfeeding outcomes, or neurodevelopmental follow‐up.

The only study that compared use of curtains with double phototherapy reported similar results for both groups.

Studies that monitored adverse events did not report increased adverse events related to the use of curtains, including acute life‐threatening events, but other rarer side effects could not be excluded.

Authors' conclusions

Moderate‐certainty evidence shows that the use of reflective curtains during phototherapy may result in greater decline in SB. Very low‐certainty evidence suggests that the duration of phototherapy is reduced, and moderate‐certainty evidence shows that the duration of hospital stay is also reduced. Available evidence does not show any increase in adverse events, but further studies are needed.

Plain language summary

Use of reflective materials during phototherapy for infants with jaundice

Review question: We wanted to find out whether use of curtains made from reflective materials hung from the side of phototherapy units improves the effectiveness of phototherapy.

Background: Jaundice (yellow discolouration of the skin) occurs in up to 60% of babies. This is due to accumulation of bilirubin. Mild elevations in bilirubin are considered normal, but when levels are very high, bilirubin could enter the brain and cause brain damage. Treatment using age‐ and risk‐specific guidelines is aimed at preventing bilirubin from reaching these levels. Phototherapy (exposing the body to light of a specific wavelength) is the usual treatment, and the intensity of light on the skin is one of the factors determining the rate of decline in bilirubin. A potentially inexpensive method to increase the intensity of light is to use reflective materials. One of the concerns is that these curtains might obscure the view of the baby.

Study characteristics: We included randomised controlled trials (RCTs). The search is up‐to‐date as of the first of November 2019.

Key results: We found 12 studies with a total of 1288 babies. Of these, 11 compared a single unit of light with or without reflective materials around the lights. One trial compared a single unit of light and reflective materials with two units of light without curtains. Types of reflective materials included white plastic, white linen, and aluminium draped on three or four sides of the baby's cot.

We found sufficient data on the primary outcome ‐ decline in bilirubin ‐ in 11 studies including 1132 babies: 10 for the first comparison and one for the second comparison.

Three studies reported a decline in bilirubin at four to eight hours. Moderate‐certainty evidence shows a small but clinically important difference favouring the use of curtains. Decline in bilirubin over 24 hours was measured in nine studies. All studies showed a faster decline in bilirubin in the curtains group, but the decline varied so widely that it was not meaningful to estimate the size of the effect. Four studies reporting the duration of phototherapy showed that it was shorter when reflective curtains were used, but this is of very low certainty. Moderate‐certainty evidence from two studies shows that the intervention reduces hospital stay by almost two days. There were no reports of any important adverse events, such as temperature instability or acute life‐threatening events due to curtains obscuring the baby, nor of other minor effects. This means that overall reflective curtains might provide benefit, but we are uncertain about whether there are any harms. None of the studies reported parent or healthcare personnel satisfaction with the curtains, or whether the curtains had any effect on breastfeeding rates.

One trial compared use of one light unit with curtains to use of two light units without curtains and showed similar results for both intervention and control groups.

Certainty of evidence: Evidence is of moderate certainty.

Summary of findings

Background

Description of the condition

Neonatal jaundice occurs in about 60% of otherwise healthy newborn infants. Although for most infants jaundice does not lead to any major morbidity, jaundice may get so severe that it can lead to kernicterus ‐ deposition of bilirubin in parts of the brain ‐ resulting in permanent brain damage (AAP 2004). Treatment with phototherapy based on age‐ and risk‐specific guidelines or nomograms is aimed at preventing bilirubin from reaching these levels.

When neonates develop jaundice during the first week of life, this most often occurs because the newborn infant has an increased rate of breakdown of haemoglobin in the presence of immature liver function, leading to unconjugated hyperbilirubinaemia. This is considered to be part of a normal physiological process. Pathological jaundice may occur if haemolysis is increased, as occurs when there is incompatibility between mother and infant blood groups, or when extravasation of blood occurs during the delivery, resulting in, for example, cephalohaematoma or subaponeurotic haemorrhage, both of which consist of haemorrhages into the scalp. In certain populations, glucose‐6‐phosphate dehydrogenase (G6PD) deficiency is an important cause of pathological jaundice (Lu 1966; Singh 1986). Other causes include impaired conjugation, as in Gilbert’s syndrome, and increased enterohepatic circulation, as is seen in breastfeeding jaundice. These causes and some others result in an increase in unconjugated bilirubin, and it is this form of bilirubin that can be treated with phototherapy. Conjugated hyperbilirubinaemia, which is regarded as a separate entity, is much less common, generally occurs later in the neonatal period, and is not treated with phototherapy.

Description of the intervention

Before phototherapy was discovered, the mainstay of treatment for hyperbilirubinaemia was exchange transfusion (ET). Although ET is effective in removing bilirubin, it is associated with many complications, including those related to the use of blood products (infection, haemolysis of transfused blood), metabolic derangements (metabolic acidosis, deranged serum calcium), cardiorespiratory complications (arrhythmia, apnoea), and complications related to umbilical venous catheteristion. The morbidity of ET ranges from 5% to 10%, and mortality ranges from 0% to 7% (Ip 2004).

Other modalities of treatment may have no proven effects (e.g. phenobarbitone) (Arya 2004; Murki 2005), or they may be effective only for very specific conditions (e.g. infusion of immunoglobulin) (Alcock 2002).

Phototherapy has been used since 1958 for treatment of neonatal hyperbilirubinaemia (Cremer 1958); it has been the mainstay of treatment since that time.

The energy provided by light converts bilirubin to water‐soluble forms through two main processes. These processes are called photo‐isomerisation and photo‐oxidation. They result in minor changes in the molecular structure of bilirubin that allow it to be excreted via the liver or the kidneys without having to undergo the process of conjugation in the liver. Conjugation, which is the rate‐limiting step of normal bilirubin excretion, is exacerbated by the relative liver immaturity of the newborn (Maisels 2008).

The rate of production of water‐soluble forms of bilirubin is dependent first on the wavelength of light. It is most efficient if the light wavelength is within the range of 450 nm to 490 nm. Second, the intensity of the light is a factor. The rate of bilirubin conversion increases linearly with the intensity of light from about 5 to 30 microWatt*cm‐2*nm‐1. It was initially perceived that light intensities higher than this did not appear to confer clinical benefit (Tan 1982). However, a study using light‐emitting diodes found a linear relation between light irradiance in the range of 20 to 55 microWatt*cm‐2*nm‐1 and a decrease in bilirubin after 24 hours of therapy, with no evidence of a saturation point (Vandborg 2012). To achieve the maximal effective level of light intensity, more or stronger lights can be used and light sources can be brought as close as possible to the skin surface (Kang 1995). Third, the surface area of skin exposed to the light will affect the rate of bilirubin conversion.

Higher light intensities can be obtained by using multiple phototherapy units, but this approach increases the cost of phototherapy and, theoretically, has increased potential to cause hyperthermia. Curtains made of reflective materials placed around the phototherapy unit (while infants are receiving phototherapy) have the potential to increase the irradiance. In some parts of the world, it may be necessary to use curtains at the side of open incubators (or phototherapy units) to protect children from convective heat loss (air flow from fans or air conditioners) or from mosquitoes. Materials used for these purposes often are not reflective in nature.

How the intervention might work

Bright surfaces such as white cloth, mirrors, and aluminium foil can reflect dispersed phototherapy light. Curtains made from reflective materials usually are attached to the phototherapy unit and hung around the infant's cot to capture light that might be dispersed away from the infant and, by their reflective nature, reflect it back onto the infant. This might increase the photo irradiance and hence result in increased bilirubin conversion. The reflective materials used may differ in their ability to reflect dispersed light. The expected increase in light intensity that reflective materials would provide is uncertain, but some comparisons between different materials have been reported in Djokomuljanto 2006. This study reported an increase in irradiance of three materials (a white plastic sheet with a paper backing behind it, a square of white bed sheeting, and a square of white cotton gauze ‐ used to make baby napkins). The greatest increase was noted with the plastic sheet. A 35% increase was reported directly below the light source, and 54% at the side of the baby cot.

Such curtains may also reflect heat, thereby increasing the risk of hyperthermia. It is possible that such curtains could obstruct the visibility of the infant and affect nursing observation; this obstruction could also affect mother‐infant bonding. When properly used, these curtains should not confer increased infection risk.

Why it is important to do this review

A recent Cochrane Review suggests that light sources from light‐emitting diodes are as effective as conventional light sources (Kumar 2011). These lights are power efficient with low heat production and have an extremely long life span (Kumar 2011). However, light‐emitting diodes are currently expensive, and further data on their safety are needed. Therefore, conventional phototherapy is likely to continue to be used for some time to come. The reflective materials used with conventional phototherapy are inexpensive; if they are found to increase the intensity and, more important, the efficiency of phototherapy while shortening the duration of treatment with little or no extra cost, this would be important in resource‐constrained settings. However, a growing body of evidence suggests that phototherapy has sufficient adverse effects that in any setting, unnecessary prolongation of phototherapy should be avoided. Increased oxidative stress markers have been found in infants who underwent phototherapy (El‐Farrash 2019). Phototherapy has been associated with childhood cancer (Auger 2019; Newman 2016), and its use is a risk factor for breastfeeding failure (Waite 2016) ‐ both reasons for shortening the duration of phototherapy. The aim of this review is to systematically compile and assess available evidence from randomised and quasi‐randomised trials comparing effects of phototherapy provided with and without reflective curtains.

Objectives

To assess the effects of reflective materials in combination with phototherapy compared with phototherapy alone for unconjugated hyperbilirubinaemia in neonates.

Methods

Criteria for considering studies for this review

Types of studies

We included only randomised controlled trials (RCTs) and quasi‐RCTs. We included only studies with individual participant allocation and did not include cross‐over studies.

Types of participants

We included studies of term and preterm neonates up to the age of 14 days (for term infants) and 21 days (for preterm infants) with unconjugated hyperbilirubinaemia receiving phototherapy.

Types of interventions

We included studies in which participants received phototherapy in combination with curtains made of reflective materials of any type in the treatment arm(s), and phototherapy alone in the comparison arm(s). The setup of the phototherapy units and its relation to the infants should be similar in both arms, except for the use of reflective materials. The reflective materials used are hung from overhead phototherapy units around the cot on at least the two long sides of the cot. If incubators are used, the surface of the reflective materials and the position should be similar as for their use in cots.

Because this review is exploring the effects of reflective materials, we made a post hoc decision to include studies comparing single phototherapy with reflective materials versus other interventions such as different reflecting materials and comparing phototherapy with reflecting curtains versus other forms of phototherapy (e.g. fibreoptic phototherapy, double phototherapy).

Types of outcome measures

Primary outcomes

1. Decline in serum bilirubin levels per unit of time over the first four to eight hours, at 24 hours, or until the first measurement of bilirubin (μmol/L per unit of time)

Secondary outcomes

1. Duration of treatment with phototherapy (hours)

2. Number of exchange transfusions within the neonatal period and number of babies requiring exchange transfusion

3. All‐cause mortality at discharge

4. Acute life‐threatening event (ALTE) during phototherapy

5. Cost of the intervention (because there may be large variation depending on materials used and the type of phototherapy units used, we will adopt a purely descriptive approach for individual studies)

6. Parental satisfaction (questionnaire‐based assessment, during or within a reasonable time after admission)

7. Medical staff satisfaction (questionnaire‐based assessment, during or within a reasonable time after admission)

8. Exclusive breastfeeding on discharge

9. Partial breastfeeding on discharge

10. Neurodevelopmental follow‐up

11. Actual measures of light intensity on infant skin during phototherapy

Adverse effects

1. Dehydration (more than expected weight loss for age during phototherapy or by clinical assessment)

2. Hyperthermia (axillary temperature > 37.5 °C)

3. Hypothermia (axillary temperature < 36.5 °C)

4. Body rash

5. Bronze discolouration of the skin

6. Interference with mother‐infant interaction (through observational or questionnaire‐based assessment)

7. Adverse effects related to problems with observation of infant (e.g. intravenous line problems)

Search methods for identification of studies

We used the standard search strategy of Cochrane Neonatal, as documented in the Cochrane Library. See the Cochrane Neonatal search strategy at http://neonatal.cochrane.org/resources-review-authors.

Electronic searches

We conducted a comprehensive search including the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 11), in the Cochrane Library; Ovid MEDLINE(R) and Epub Ahead of Print, In‐Process & Other Non‐Indexed Citations, Daily and Versions(R) (1946 to 1 November 2019); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1981 to 1 November 2019). We have included the search strategies for each database in Appendix 1. We did not apply language restrictions.

We searched clinical trial registries for ongoing and recently completed trials. We searched the World Health Organization’s International Clinical Trials Registry Platform (ICTRP) at www.who.int/ictrp/search/en/ and the US National Library of Medicine’s ClinicalTrials.gov at clinicaltrials.gov via Cochrane CENTRAL. Additionally, we searched the ISRCTN Registry for any unique trials not found through the Cochrane CENTRAL search.

Searching other resources

We communicated with experts and searched the reference lists of any identified reviews and included trials for references to other trials. We searched abstracts and conference and symposium proceedings of the Perinatal Society of Australia and New Zealand. For identified unpublished trials, we contacted the corresponding investigator for information. We considered unpublished studies and studies reported only as abstracts as eligible for review. We also contacted the corresponding or first author of identified RCTs for additional information about studies when further data were required.

Data collection and analysis

Selection of studies

The lead review author performed the search for trials with the assistance of Cochrane Neonatal. Two review authors (LCH and IJ) independently screened titles and abstracts obtained through the electronic searches to create a pool of eligible studies. The lead review author obtained the full articles of the latter, which two review authors (HVR and LCH) then independently scrutinised for relevance using a standardised eligibility form with pre‐defined inclusion criteria. Any disagreement was handled by a third review author (JJH). Possible duplicate publications were assessed by comparing author names, locations and settings, specific details of the intervention, numbers of participants and their baseline data, and date and duration of studies. We obtained data sets that are as complete as possible. We recorded the selection process in sufficient detail to complete a PRISMA flow diagram (Moher 2009), along with the Characteristics of excluded studies table.

Data extraction and management

For included studies, we extracted data concerning study identity (title, authors, reference), design, methods, eligibility, risk of bias, clinical features of participants, interventions and outcomes, and treatment effects, using a specially designed data extraction form. For studies that we initially considered eligible for inclusion but that we excluded after reading the full report, we documented the reason for exclusion.

Two review authors (LCH and IJ) independently extracted and compared all data; they resolved any discrepancies by discussion or by consultation with a third review author (JJH). Unresolved disagreements were referred for arbitration by a third review author or mentor.

Assessment of risk of bias in included studies

Two review authors (HVR and IJ) independently assessed the risk of bias (low, high, or unclear) of all included trials using the Cochrane "Risk of bias" tool for the following domains (Higgins 2019).

1. Sequence generation (selection bias).

2. Allocation concealment (selection bias).

3. Blinding of participants and personnel (performance bias).

4. Blinding of outcome assessment (detection bias).

5. Incomplete outcome data (attrition bias).

6. Selective reporting (reporting bias).

7. Any other bias.

Any disagreements were resolved by discussion or by consultation with a third assessor (JJH). See Appendix 2 for a more detailed description of risk of bias for each domain.

Measures of treatment effect

We carried out data analysis using Review Manager 5 (RevMan 2014). If it was possible to conduct a meta‐analysis of identified trials, the effect measures for binary outcomes were risk ratio (RR) and risk difference (RD). For binary outcome(s), we planned to calculate the number needed to benefit (NNTB) or the number needed to harm (NNTH) when the RD is statistically significant. For continuous outcomes, the effect measure is the mean difference (MD). If scales of different lengths are used, and if we judged that the outcome measured is similar enough, we used the standardised mean difference (SMD). For all estimates, we provide 95% confidence intervals (CIs).

Unit of analysis issues

We did not anticipate any problems with unit of analysis issues.

Dealing with missing data

We contacted the respective investigators in cases where adequate information was not available within the papers.

Assessment of heterogeneity

We estimated the amount of heterogeneity of treatment effect across trials using the I² statistic. We used the following cutoffs and labels: < 25%: no heterogeneity, 25% to 49%: low heterogeneity, 50% to 74%: moderate heterogeneity, and > 75%: substantial heterogeneity. If substantial heterogeneity was present, we explored its potential sources, taking into account differences in study design, participants, and interventions used in the trials. We explored possible differences using a limited number of pre‐specified subgroup analyses (see Subgroup analysis and investigation of heterogeneity).

Assessment of reporting biases

We planned to create a funnel plot if 10 or more studies were included in the meta‐analysis of the same outcome. If there would be skewing with positive results being published and negative results not being published, we planned to report this and attempt to explain, recognising that not all funnel plot asymmetry is due to publication bias.

Data synthesis

We used a fixed‐effect model for analysis as recommended by the Cochrane Neonatal Group (http://neonatal.cochrane.org/resources-review-authors). When meta‐analysis was deemed appropriate, we performed the analysis using RevMan 5 software supplied by Cochrane (RevMan 2014).

Certainty of evidence

We used the GRADE approach, as outlined in the GRADE Handbook (Schünemann 2013), to assess the certainty of evidence for the following (clinically relevant) outcomes: decline in bilirubin, exchange transfusion, acute life‐threatening events, parental satisfaction, and breastfeeding at discharge.

Two review authors independently assessed the certainty of evidence for each of the outcomes above. We considered evidence from RCTs as high certainty but downgraded the evidence one level for serious (or two levels for very serious) limitations based upon the following: design (risk of bias), consistency across studies, directness of evidence, precision of estimates, and presence of publication bias. We used the GRADEpro GDT Guideline Development Tool to create a "Summary of findings" table to report the certainty of evidence.

The GRADE approach results in an assessment of the certainty of a body of evidence according to one of four grades.

1. High: we are very confident that the true effect lies close to that of the estimate of the effect.

2. Moderate: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.

3. Low: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.

4. Very low: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

Subgroup analysis and investigation of heterogeneity

We visually inspected the forest plot, if indicated. If we had sufficient data, we intended to perform the following subgroup analyses.

1. Types, sizes, and configurations of different reflective materials (as stated by study authors).

2. Phototherapy methods and irradiance of units used in conjunction.

3. Preterm versus term gestational age (< 28 weeks, 28 to 32 weeks, > 32 weeks to 38 weeks, and term).

4. Severity of baseline jaundice (≤ 340 micromol/L and > 340 micromol/L).

The exact cutoffs that we use for these subgroups will depend on the availability of subgroups in the included studies.

For the purpose of creating subgroups according to the severity of jaundice, we used the cutoff value of 300 μmol/L.

Sensitivity analysis

We conducted a sensitivity analysis based on trial quality to test judgements made in our risk of bias assessment.

Results

Description of studies

Results of the search

The search resulted in 1402 studies (1015 after removal of duplicates). After screening, we retrieved full‐text articles for 15 articles; 12 of these were included in the qualitative analysis and 11 in the quantitative analysis of this review, as shown in Figure 1.

Included studies

We included 12 studies (Abd Hamid 2013; Babaei 2013; Dachlan 2015; Devpura 2017; Djokomuljanto 2006; Eggert 1988; Kurniasih 2011; Lahiri 2016; Lee 2014; Magaspi 2014; Rashmi 2015; Sivanandan 2009): 11 in the first comparison and 1 in the second comparison (Abd Hamid 2013).

Babaei 2013 included 182 term infants, more than 48 hours but less than 14 days of age, with SB of 300 to 360 μmol/L without haemolysis. The intervention consisted of standard phototherapy with a white shiny plastic cover around three sides of the phototherapy unit. The intervention was compared with standard phototherapy without curtains. Outcomes included SB on admission and after 12 and after 24 hours of phototherapy, duration of phototherapy, and duration of hospital stay. Adverse effects were also reported.

Dachlan 2015 included 70 term neonates, more than 24 hours of age, with neonatal jaundice requiring phototherapy. Asphyxia, G6PD deficiency, severe infection, and unknown birth weight were exclusion criteria for this study. The intervention consisted of a phototherapy unit with aluminium reflecting materials on four sides of the unit. Controls received similar phototherapy but without reflecting materials. Outcome measures included SB after 12, 24, and 48 hours after the start of phototherapy and the duration of phototherapy. Adverse effects were not reported.

Devpura 2017 included 100 healthy term neonates with non‐haemolytic jaundice between 24 hours and 14 days of age. The intervention consisted of a phototherapy unit with white reflecting materials on three sides of the unit. The type of material used was not reported. Controls received similar phototherapy but without reflecting materials. Outcome measures included the fall of SB at the end of 12 hours and 24 hours, the rate of fall of SB in the first 12 hours and between 12 hours and 24 hours, and the duration of phototherapy. There were no pre‐specified adverse events, and there was no report of whether any adverse events were detected.

Djokomuljanto 2006 included 100 term newborns with uncomplicated neonatal jaundice presenting in the first week of life. Researchers compared phototherapy with curtains (white plastic) with identical phototherapy without curtains. Outcomes were mean decrease in SB after four hours of phototherapy, median duration of phototherapy, and adverse effects of phototherapy.

Eggert 1988 included 70 newborns above the age of 40 hours with uncomplicated hyperbilirubinaemia, who were cared for in incubators. Children treated with antibiotics and with blood group incompatibility were excluded. The intervention was phototherapy (special blue light) with white cloth draped at the four outer walls of the phototherapy unit; the intervention was compared with the same type of phototherapy without white cloth around it at four sides (a third group was also studied with a different type of phototherapy, not relevant to our research question). Main outcomes were SB at 24 hours and duration of phototherapy. Adverse effects were not reported.

Kurniasih 2011 included 63 infants with uncomplicated hyperbilirubinaemia without haemolytic disease. The intervention was phototherapy (compact blue lights) with white plastic curtains around the phototherapy.units, and the control was similar phototherapy units without any curtains. Main outcomes were mean decrease in bilirubin after 12 and 24 hours of phototherapy and total duration of phototherapy. Adverse effects were reported.

Lahiri 2016 included 100 term infants between 24 hours and 10 days of age, who were exclusively breastfed, with birth weight > 2500 grams and SB < 340 μmol/L. Infants with haemolysis were excluded. The intervention was compact fluorescent phototherapy light with white cotton cloth with an inner reflecting surface hung from three sides of the phototherapy unit. The control group received similar phototherapy without curtains. Main outcomes included SB at 4, 12, and 24 hours of phototherapy; mean SB decline; duration of phototherapy; and mean spectral irradiance. Adverse effects were not reported.

Rashmi 2015 included 30 term infants weighing more than 2500 grams with SB between 300 and 340 μmol/L, who were aged 48 hours to 14 days. Researchers excluded infants with haemolysis and infants on phenobarbitone or herbal preparations. They compared phototherapy with and without curtains, but the nature of the curtains was not reported. Outcomes were SB after 24 and 48 hours of phototherapy. Adverse effects were monitored but were not reported.

Magaspi 2014 included 201 term babies below seven days of age without evidence of haemolysis. The intervention consisted of phototherapy with aluminium foil on three sides of the cot. The control arm was partially enclosed with a white material at the level of the cot (there was a third arm, which was not relevant to this research question). Outcomes were SB at 24 hours of phototherapy and duration of phototherapy. Adverse effects were not reported.

Lee 2014 (available only in abstract format) included 108 preterm and term healthy infants with jaundice requiring phototherapy. The intervention group had white curtains hanging around the phototherapy unit. The control group received phototherapy without the addition of a white curtain. Outcomes were SB at 24 hours of phototherapy and mean duration of hospitalisation. Adverse effects, including skin rash, were reported. However, no quantitative data were included in the abstract. Therefore this study could not be included in the meta‐analysis.

Sivanandan 2009 included healthy term neonates with non‐haemolytic jaundice between 24 hours and 10 days of age with SB < 357 μmol/L. Babies requiring exchange transfusion, or having evidence of haemolysis, were excluded. The intervention consisted of a phototherapy unit with white plastic sheets with an inner reflective surface on three sides of the unit. Controls received similar phototherapy but without curtains. Outcomes reported were rate of fall of SB per hour during the first eight hours, reduction in SB after 24 hours, number of exchange transfusions, all‐cause mortality, and the following side effects: loose stools, feeding intolerance, skin rashes, temperature, vomiting, decreased urine output, and others.

Abd Hamid 2013 included 156 infants with birth weight more than 2.3 kg and with SB more than 300 μmol/L for babies more than 48 hours of age, and more than 250 μmol/L for babies less than 48 hours of age. The comparison was between double phototherapy and single therapy with reflective curtains (silver‐coloured reflecting cloth) on three sides of the phototherapy unit. Main outcomes reported included mean decrease in SB four and 10 hours after the start of phototherapy, duration of phototherapy, number of exchange transfusions, all‐cause mortality, ALTE, and adverse effects.

Participants

All studies included term babies with jaundice requiring phototherapy according to international or national guidelines (AAP 2004). Only Lee 2014 included term and preterm babies. Ten studies reported exclusion of at least one cause of haemolysis. For six studies, the lower limit of age at study entry was 24 hours after birth, for another study 48 hours (Babaei 2013), and for the remaining four studies, this was not specified. The upper limit of age varied from 10 to 14 days. Only one study was performed in a high‐income country (Eggert 1988). All others were conducted in middle‐income countries. Baseline bilirubin levels at study entry were similar for intervention and control groups.

Outcomes

The primary outcome was reported in all 12 studies, but data were sufficient for analysis in only 11 of these. There were differences in the timing of measurement. Four studies reported the first bilirubin assessment at four to eight hours (Abd Hamid 2013; Djokomuljanto 2006; Lahiri 2016; Sivanandan 2009), and nine studies reported assessment of bilirubin at 24 hours, but in only four studies was this the first measurement. For Abd Hamid 2013, we obtained from study authors bilirubin levels measured at 24 hours. Decline in bilirubin was reported as decline from baseline or as absolute bilirubin values post intervention (after specified time periods of phototherapy). The outcome measure reported by the authors of each study was used for analysis of primary outcomes.

Ten studies pre‐specified the adverse effects they would report; Dachlan 2015 and Eggert 1988 did not.

Excluded studies

A total of three studies were excluded from this review. We excluded two studies because they used reflective mirrors behind the lights of phototherapy units and did not have reflective materials hanging around the unit (Hashim 2015; Salehzadeh 2010). Standard specifications of many commonly used and commercially available phototherapy units already include a reflective aluminium coloured surface behind the lamps to increase irradiance. Based on this and on our inclusion criteria, we judged that these studies should not be included in the review. Another RCT, initially retrieved as full text, examined the effects of several interventions on neonatal jaundice, but we excluded this study because the interventions did not include use of reflective materials (Martinez 1992). We identified no ongoing studies.

Risk of bias in included studies

Please see Figure 2 and Figure 3 for a summary of risk of bias.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Allocation

All studies reported that allocation to the intervention or control group was random. For three studies, available information was sufficient to conclude that risk of bias for sequence generation was low; for the remaining nine studies, risk of bias was unclear. Concealment of allocation was adequately documented for five studies. In the other seven studies, this was judged as unclear.

Blinding

Because of the nature of the intervention, it was not possible to blind parents and healthcare professionals to the intervention. We judged that lack of blinding may have influenced the way babies were taken care of; thus we concluded that all studies included in this review were at high risk of performance bias. The main outcome in this review is based on laboratory measurements of SB. It was specifically stated in only one study that the outcome assessor was blinded to the intervention. However we judged measurement of SB to be an objective measure that would be unlikely to be affected by lack of blinding. Thus even if the outcome assessor were not blinded, we judged this to show low risk for detection bias. We judged that other outcomes such as duration of phototherapy, length of stay, or detection of adverse effects would be at high risk for detection bias.

Incomplete outcome data

We judged nine studies to have low risk for attrition bias because the dropout rate or non‐reported data were less than 10% and were balanced across groups. However, we judged three studies to have unclear risk for attrition bias (Eggert 1988; Lee 2014; Magaspi 2014).

Selective reporting

The initial protocols were not available for all included studies. However for all studies, all expected outcomes were reported. We judged seven studies to be at low risk for reporting bias. Two studies reported outcomes in their methods section that were not reported in the results section; therefore we judged them to have high risk for reporting bias. For the other three studies, available information was insufficient to permit a conclusion, and we judged them to have unclear reporting bias.

Other potential sources of bias

For all included studies, we identified no other additional sources of bias.

Effects of interventions

See: Table 1; Table 2

Summary of findings 1

Phototherapy with reflective curtains compared to phototherapy alone for newborn infants with unconjugated hyperbilirubinaemia

Summary of findings 2

Reflective curtains compared to intensified phototherapy for newborn infants with unconjugated hyperbilirubinaemia

Comparison 1. Reflective materials versus single phototherapy

Primary outcome

Decline in bilirubin

Decline in SB at four to eight hours (Analysis 1.1)

Three studies reported this outcome (Djokomuljanto 2006; Lahiri 2016; Sivanandan 2009). The mean difference (MD) at four to eight hours was ‐14.61 (95% confidence interval (CI) ‐19.80 to ‐9.42; I² = 57%; 3 studies; 281 participants; moderate‐certainty evidence (Analysis 1.1).

Analysis

Comparison 1: Phototherapy with reflective curtains versus phototherapy alone, Outcome 1: Decline in bilirubin at 4 to 8 hours

Decline in SB at 24 hours (Analysis 1.2)

Nine studies reported this outcome (Babaei 2013; Dachlan 2015; Devpura 2017; Eggert 1988; Kurniasih 2011; Lahiri 2016; Magaspi 2014; Rashmi 2015; Sivanandan 2009). Therefore in addition to our pre‐specified primary outcome of bilirubin at four to eight hours, we made a post hoc decision to report bilirubin at 24 hours as a primary outcome. Of the nine studies that reported bilirubin at 24 hours, this the first measurement for only four studies. For all nine studies, effect estimates for the mean difference favoured the use of curtains; however heterogeneity was substantial (I² = 97%), so we were not able to provide a pooled estimate (Analysis 1.2; very low‐certainty evidence). Heterogeneity was not explained by the type of curtain used (Analysis 1.2). Within subgroups, heterogeneity was also substantial (I² varied between 85% and 98%). Subgroup analyses for irradiance were not possible due to insufficient data. Studies that clearly described the light source reported the use of compact fluorescent lights (six studies: Abd Hamid 2013; Devpura 2017; Djokomuljanto 2006; Kurniasih 2011; Lahiri 2016; Sivanandan 2009), or they reported the use of conventional fluorescent lights (four studies: Babaei 2013; Dachlan 2015; Eggert 1988; Magaspi 2014); one of these studies used daylight white light (Magaspi 2014), and one did not specify the light used (Rashmi 2015). Because evidence suggests no differences in terms of irradiance or effectiveness between compact and standard fluorescent lights (Sarin 2006), and because the number studies using other light source types was small, subgroup analysis based on the type of light source would not be meaningful. We were also unable to perform subgroup analysis according to gestational age because no studies included solely preterm babies.

Analysis

Comparison 1: Phototherapy with reflective curtains versus phototherapy alone, Outcome 2: Decline in serum bilirubin (over 24 hours)

Mean decline in SB per hour

Sivanandan 2009 reported the rate of decline of SB per hour: Mean difference per hour was ‐3.39 (95% CI ‐6.88 to 0.10; 1 study; 84 participants; very low‐certainty evidence).

Secondary outcomes

Duration of phototherapy

Duration of phototherapy was reported in five studies; however, Djokomuljanto 2006 reported this as a median with interquartile range and hence was not included in the analysis. For the four studies with analysable data (Babaei 2013; Devpura 2017; Lahiri 2016; Sivanandan 2009), all effect estimates favoured the use of reflective curtains. However heterogeneity between studies was substantial (I² = 88%), precluding a pooled estimate (Analysis 1.5;very low‐certainty evidence). Djokomuljanto 2006 also reported that the median duration of phototherapy was reduced in the reflective curtains group.

Analysis

Comparison 1: Phototherapy with reflective curtains versus phototherapy alone, Outcome 5: Duration of phototherapy (in hours)

Duration of hospital stay

Babaei 2013 and Djokomuljanto 2006 reported this outcome for 179 infants. Mean difference in hospital stay (hours) was reduced in the intervention group at ‐41.08 (95% CI ‐45.92 to ‐36.25; moderate‐certainty evidence).

Other secondary outcomes

Two studies reported no exchange transfusion; the remaining nine studies did not report this outcome.

Mortality was not specifically reported in any study; however, Kurniasih 2011 reported one death in the treatment group during the study period but provided no further details. We contacted study authors twice for further information, but they have not responded.

The difference in irradiance between the two groups was reported in six studies (Abd Hamid 2013; Devpura 2017; Djokomuljanto 2006; Eggert 1988; Kurniasih 2011; Sivanandan 2009). Information was insufficient to permit conclusions or pooling of results.

Other pre‐defined outcomes, including ALTE during phototherapy, cost of the intervention, parental and medical staff satisfaction, exclusive or partial breastfeeding upon discharge, and long‐term neurological outcomes, were not reported in any of the studies.

Comparison 2. Reflective materials versus double phototherapy

Only one trial included a total of 156 infants and compared phototherapy with reflective curtains versus double phototherapy (two compact fluorescent phototherapy units from above) (Abd Hamid 2013). Of our pre‐specified outcomes, study authors reported the decline in bilirubin at four hours and duration of phototherapy. There was little or no difference in the mean decline in bilirubin at four hours (MD 0.17, 95% CI ‐8.58 to 8.92; low‐certainty evidence) nor in the duration of phototherapy (hours) (MD 4.04, 95% CI ‐1.56 to 9.64; low‐certainty evidence).

Adverse events

Data on adverse events are presented in the table below. Listed pre‐specified events are those reported in the methods section as being monitored. Ten studies pre‐specified specific adverse events, and two did not. These two studies also did not report whether any adverse events were detected. Adverse events are shown in Table 1.

Table 1. Adverse events

* Not reported signifies that adverse events were not mentioned in the results section. None detected means that adverse events were specifically reported, but none were identified.

Sensitivity analysis

Sensitivity analysis performed by removing trials at high risk of bias did not substantively change the level of heterogeneity (Magaspi 2014; Rashmi 2015).

Discussion

Summary of main results

Eleven trials including a total of 1180 participants met the inclusion criteria for this review. Only three studies reported the pre‐specified outcome ‐ bilirubin after four to eight hours of phototherapy. We found moderate‐certainty evidence showing that use of reflective curtains resulted in a decline in bilirubin at this time point. The difference resulted in a small decline of 14 μmol/dL (mean difference (MD) ‐14.61, 95% confidence interval (CI) ‐19.80 to ‐9.42). Although no data are available to inform what a clinically important difference might be, we believe that most clinicians would consider this decline, although small, to be clinically meaningful and sufficient to prevent brain damage, particularly for infants who have jaundice severe enough to threaten the brain.

Nine studies reported a drop in bilirubin after 24 hours of phototherapy. For this outcome, the effect estimate for each trial favoured the use of curtains, but heterogeneity was too substantial to permit a sensible estimate of the effect size through meta‐analysis. Similar results were obtained when we analysed serum bilirubin (SB) at first measurement. Overall, these results support the use of reflective curtains, but there is uncertainty about the extent of the decline. Subgroup analyses (based on type of reflective material used or baseline levels of SB) could not explain the heterogeneity. Adverse effects, when reported, were mild and showed no differences between groups. The secondary outcome ‐ duration of phototherapy ‐ was reported in six studies. Each trial favoured the use of reflective materials, but again heterogeneity was too substantial for meta‐analysis of the data. Duration of hospital admission was reported in two trials and was reduced with the use of reflective materials. One trial compared the use of one phototherapy unit with reflective curtains versus the use of two phototherapy units and provided low‐certainty evidence suggesting that there was little to no difference between these two interventions.

Overall completeness and applicability of evidence

Because most of the included studies excluded infants with haemolysis, our results apply mainly to infants with non‐haemolytic causes of jaundice.

The purpose of phototherapy is to prevent exchange transfusion, and the purpose of exchange transfusion is to prevent kernicterus. Unfortunately, we found insufficient information about either of these outcomes. Exchange transfusion is infrequent, and because of interventions now in place to prevent rhesus disease and the advent of phototherapy, kernicterus is now quite rare. Therefore, randomised controlled trials (RCTs) may not serve as the best way to measure the impact of our intervention on these important outcomes. This also applies to some of the adverse effects that might occur with reflective curtains, including acute life‐threatening events (ALTEs) ‐ an important perceived risk that might arise due to curtains obscuring the infant. However, breastfeeding and parental satisfaction are important outcomes that could be measured in the context of an RCT. We did not find information on either of these outcomes in any of the included studies.

We preferred to measure decline in SB at four to eight hours for our primary outcome for several reasons. First, the rate of decline in SB is exponential. The higher the SB, the greater the decline that would be expected. Second, the first four to eight hours is the most critical time in the management of hyperbilirubinaemia. Third, by 24 hours, there may be some attrition because some babies are well enough for discharge home. Three studies reported attrition 24 hours after the start of the intervention, and for four it is unclear whether there might have been attrition because it is unclear how many infants were analysed.

We observed substantial heterogeneity between studies for the outcome decline in bilirubin. This is to be expected for several reasons. First, age at recruitment would be important because babies would be at different stages in the natural history of neonatal jaundice. Bilirubin production increases over the first few days of the condition and then levels off and declines. The SB increase and decline mirrors this, peaking often at about 96 hours of life. Therefore babies might respond to the intervention differently depending on their age at recruitment. Across studies, the mean age at recruitment ranged from 30 hours to 6 days of age. Second, preterm infants might respond differently. When the irradiance of phototherapy is increased, efficacy is increased, and reflective curtains increase irradiance by reflecting scattered light from the light source back to the baby. This varies depending on the type of reflective material used and the distance between the light source and the curtains, as well as the distance between the curtains and the baby. The exponential relationship between irradiance and distance from the light source would mean that small differences in distance could have a considerable effect on irradiance, thus exaggerating differences between studies. For this same reason, the distance between the patient and the light source could also contribute to the heterogeneity we encountered. Reported increases in irradiance resulting from the use of reflecting curtains of a different nature varied among studies, and some studies did not report irradiance, nor the distance between the phototherapy unit and the patient. Subgroup analysis suggests that heterogeneity is not explained by the type of reflective material used nor by the baseline SB. It is not possible to look at the contribution of distance because this varies widely. We were unable to look at the effects of gestation.

Quality of the evidence

We used the GRADE approach to assess the certainty of evidence.

We considered evidence to be of moderate certainty for decline in bilirubin after four to eight hours of phototherapy and for duration of stay in the hospital. We downgraded for study limitations (one level because of the nature of the intervention, or because hospital staff and caregivers of patients could not be blinded to the intervention) and for imprecision (because the number of trials reporting these two outcomes was low).

For the other outcomes reported in this review, we graded evidence as very low certainty. We downgraded evidence based on study limitations (one level for lack of blinding) and on imprecision (one level), as well as for inconsistency (heterogeneity) (one level), making pooling of data not sensible.

For the second comparison, we downgraded the evidence two levels because this involved only one small study with wide confidence intervals, which included the possibility of a decline or an increase in the outcome. In addition, we could not assess whether there was inconsistency because there was only one study.

Potential biases in the review process

One study that met our inclusion criteria and included our primary outcome was available only in abstract form and did not include any quantitative data, although study authors concluded that reflective materials resulted in a more rapid decline in SB and a shorter hospital stay. Another study was available only in the form of a "slide" presentation, which included sufficient quantitative data to be included in the analysis. Both of these studies were identified through additional searches, suggesting that there could yet be other unidentified studies.

The initially planned primary outcome (decline in SB after four to eight hours of phototherapy) was reported in only three trials for the first comparison. We added post hoc a primary outcome (decline in SB after 24 hours) because this was reported in nine trials. Without this added outcome, assessment of available evidence would have been extremely incomplete.

Our search revealed an article that described the use of reflective materials with a single phototherapy unit versus the use of two phototherapy units without curtains. All study authors deemed this sufficiently important to be added as a second comparison post hoc.

Two review authors were involved in studies included in this review: HVR in Abd Hamid 2013 and Djokomuljanto 2006; and IJAH in Abd Hamid 2013. Extreme care was taken to minimise involvement of these two review authors in decisions concerning their own studies.

A potential bias of this review could be our definition of what constitutes our intervention. We wanted to study the use of additional reflective materials hung around the perimeter of the light bank. We do not have a definition of a reflective material, and only one of the included studies made an attempt to show that the material used by researchers was reflective (Djokomuljanto 2006). We excluded two studies because we judged that the intervention used did not meet our inclusion criteria. The intervention in these two studies consisted of a reflective surface behind the bank of lights. Almost all commercially available phototherapy lights have such a reflective surface behind the light bank, hence our reason for these exclusions. Nevertheless, making these judgements could be conceived as a bias in the review process.

Agreements and disagreements with other studies or reviews

A previously published systematic review included only five trials, all of which we identified (Lee 2018). The method of assessment of quality used in this review differed from our method. Review authors assessed the quality of trials by using the Physiotherapy Evidence Database Scale and the Consolidated Standards of Reporting Trials Guidelines. They did not identify the between‐study heterogeneity that we encountered but similarly concluded that use of reflective materials could improve the "efficacy" of phototherapy. They concluded that this did not cause adverse effects.

Authors' conclusions

Implications for practice

Our findings provide support for the use of reflective curtains. Moderate‐certainty evidence shows that reflective materials hung around a bank of phototherapy lights result in a small but clinically meaningful greater decline in bilirubin over the first four to eight hours. At 24 hours, heterogeneity was too substantial to allow for meaningful overall effect estimates, although each of the individual included trials favoured the use of reflective materials. However, we found no data from RCTs to inform whether the reduction in bilirubin translates to a reduction in exchange transfusion. Limited very low‐certainty evidence suggests that the duration of phototherapy is reduced. However, moderate‐certainty evidence shows that the duration of hospital stay is reduced. The heterogeneity that we encountered can be explained by differences between age at recruitment and severity of jaundice, types of reflective material used, and timing of outcome measurement. Adverse events were reported in nine trials and were similar between groups. FIve of these nine trials reported that no adverse events occurred in either group. However, due to their relative rarity, information about potentially serious adverse events such as ALTE is lacking.

Implications for research

If further studies were to be undertaken to assess a single bank of phototherapy lights with reflective materials versus single phototherapy alone, it is recommended that bilirubin should be measured at four to eight hours because neonatal jaundice could have resolved by 24 hours, and the decline in the first hours of phototherapy would be most important to prevent bilirubin toxicity. Inclusion of babies with haemolysis may be useful for assessment of the effect of this intervention on this group of infants. Further research to identify the optimal reflective material might be useful, not only to determine the reflectance of these materials but also to assess the availability and optimal arrangement of curtains in terms of efficacy and safety. In the meantime, further studies should adequately describe the intervention including the reflecting material used, the distance between the curtain and the baby, the distance of the light source from the baby, and irradiance in both intervention and control arms.

It is also recommended that breastfeeding outcomes should be measured, as well as parent and healthcare personnel acceptability of the intervention. Serious adverse events may have to be assessed by observational studies. More studies conducted to compare single phototherapy with curtains versus two sets of phototherapy may be useful.

History

Protocol first published: Issue 12, 2015
Review first published: Issue 7, 2020

Acknowledgements

We thank Dr. S Djokomuljanto for replying to our enquiries regarding his study (Djokomuljanto 2006).

We would like to thank Cochrane Neonatal: Colleen Ovelman, Managing Editor; Caitlin O'Connell Eckert, Assistant Managing Editor; Roger Soll, Co‐coordinating Editor; and Bill McGuire, Co‐coordinating Editor, who provided editorial and administrative support. Carol Friesen, Information Specialist, designed and ran the literature searches, and Colleen Ovelman peer‐reviewed the Ovid MEDLINE search strategy.

Cochrane Neonatal Senior Editor Jeffrey Horbar and Cochrane Neonatal Associate Editor Vibhuti Shah have peer‐reviewed and offered feedback on this review.

Appendices

Appendix 1. Search methods

The RCT filters have been created using Cochrane's highly sensitive search strategies for identifying randomised trials (Higgins 2019). The neonatal filters were created and tested by the Cochrane Neonatal Information Specialist.

CENTRAL via CRS Web

Date searched: 01 November 2019
Terms:
1MESH DESCRIPTOR Hyperbilirubinemia EXPLODE ALL AND CENTRAL:TARGET
2MESH DESCRIPTOR Hyperbilirubinemia, Neonatal EXPLODE ALL AND CENTRAL:TARGET
3MESH DESCRIPTOR Jaundice, Neonatal EXPLODE ALL AND CENTRAL:TARGET
4MESH DESCRIPTOR jaundice EXPLODE ALL AND CENTRAL:TARGET
5MESH DESCRIPTOR Jaundice, Obstructive EXPLODE ALL AND CENTRAL:TARGET
6MESH DESCRIPTOR kernicterus EXPLODE ALL AND CENTRAL:TARGET
7hyperbilirubinemi* OR hyperbilirubinaemi* OR bilirubinemi* OR bilirubinaemi* OR jaundice OR jaundices OR jaundiced OR kernicterus OR icter* OR (encephalopath* ADJ2 bilirubin) AND CENTRAL:TARGET
8#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 AND CENTRAL:TARGET
9MESH DESCRIPTOR Phototherapy EXPLODE ALL AND CENTRAL:TARGET
10phototherap* OR (photoradiation ADJ3 therap*) OR (light ADJ3 therap*) AND CENTRAL:TARGET
11#10 OR #9 AND CENTRAL:TARGET
12MESH DESCRIPTOR Infant, Newborn EXPLODE ALL AND CENTRAL:TARGET
13infant or infants or infant’s or "infant s" or infantile or infancy or newborn* or "new born" or "new borns" or "newly born" or neonat* or baby* or babies or premature or prematures or prematurity or preterm or preterms or "pre term" or premies or "low birth weight" or "low birthweight" or VLBW or LBW or ELBW or NICU AND CENTRAL:TARGET
14#13 OR #12 AND CENTRAL:TARGET
15#8 AND #11 AND #14 AND CENTRAL:TARGET
# of Results: 654
MEDLINE via Ovid:
Date ranges: 1946 to 01 November 2019
Terms:
1. exp hyperbilirubinemia/ or exp hyperbilirubinemia, neonatal/ or exp jaundice, neonatal/ or exp jaundice/ or exp jaundice, obstructive/ or exp kernicterus/
2. hyperbilirubinemi*.mp.
3. hyperbilirubinaemi*.mp.
4. bilirubinemi*.mp.
5. bilirubinaemi*.mp.
6. jaundice.mp.
7. (jaundices or jaundiced).mp.
8. kernicterus.mp.
9. icter*.mp.
10. (encephalopath* adj2 bilirubin).mp.
11. 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10
12. exp Phototherapy/
13. phototherap*.mp.
14. (photoradiation adj3 therap*).mp.
15. (light adj3 therap*).mp.
16. 12 or 13 or 14 or 15
17. exp infant, newborn/
18. (newborn* or new born or new borns or newly born or baby* or babies or premature or prematurity or preterm or pre term or low birth weight or low birthweight or VLBW or LBW or infant or infants or 'infant s' or infant's or infantile or infancy or neonat*).ti,ab.
19. 17 or 18
20. randomized controlled trial.pt.
21. controlled clinical trial.pt.
22. randomized.ab.
23. placebo.ab.
24. drug therapy.fs.
25. randomly.ab.
26. trial.ab.
27. groups.ab.
28. or/20‐27
29. exp animals/ not humans.sh.
30. 28 not 29
31. 19 and 30
32. randomi?ed.ti,ab.
33. randomly.ti,ab.
34. trial.ti,ab.
35. groups.ti,ab.
36. ((single or doubl* or tripl* or treb*) and (blind* or mask*)).ti,ab.
37. placebo*.ti,ab.
38. 32 or 33 or 34 or 35 or 36 or 37
39. 18 and 38
40. limit 39 to yr="2018 ‐Current"
41. 31 or 40
42. 11 and 16 and 41

CINAHL via EBSCOhost

Date ranges: 1981 to 01 November 2019
Terms:
(hyperbilirubinemi* OR hyperbilirubinaemi* OR bilirubinemi* OR bilirubinaemi* OR jaundice OR jaundices OR jaundiced OR kernicterus OR icter* OR (encephalopath* AND bilirubin))
AND
(phototherap* OR (photoradiation AND therap*) OR (light AND therap*))
AND
(infant or infants or infant’s or infantile or infancy or newborn* or "new born" or "new borns" or "newly born" or neonat* or baby* or babies or premature or prematures or prematurity or preterm or preterms or "pre term" or premies or "low birth weight" or "low birthweight" or VLBW or LBW)
AND
(randomized controlled trial OR controlled clinical trial OR randomized OR randomised OR placebo OR clinical trials as topic OR randomly OR trial OR PT clinical trial)

ISRCTN

Date searched: 01 November 2019
Terms:
Condition: Hyperbilirubinaemia AND Interventions: Phototherapy AND Participant age range: Neonate
Condition: Hyperbilirubinemia AND Interventions: Phototherapy AND Participant age range: Neonate
Condition: Jaundice AND Interventions: Phototherapy AND Participant age range: Neonate

Appendix 2. Risk of bias tool

We used the standard methods of Cochrane and Cochrane Neonatal to assess the methodological quality (to meet the validity criteria) of trials. For each trial, we sought information regarding the method of randomisation and blinding and reporting of all outcomes of all infants enrolled in the trial. We assessed each criterion as having low, high, or unclear risk. Two review authors separately assessed each study. We resolved any disagreement by discussion. We added this information to the Characteristics of included studies table. We evaluated the following issues and entered our findings into the risk of bias table.

1. Sequence generation (checking for possible selection bias). Was the allocation sequence adequately generated?

For each included study, we categorised the method used to generate the allocation sequence as:

• low risk (any truly random process, e.g. random number table; computer random number generator);

• high risk (any non‐random process, e.g. odd or even date of birth; hospital or clinic record number); or

• unclear risk.

2. Allocation concealment (checking for possible selection bias). Was allocation adequately concealed?

For each included study, we categorised the method used to conceal the allocation sequence as:

• low risk (e.g. telephone or central randomisation; consecutively numbered sealed opaque envelopes);

• high risk (open random allocation; unsealed or non‐opaque envelopes, alternation; date of birth); or

• unclear risk.

3. Blinding of participants and personnel (checking for possible performance bias). Was knowledge of the allocated intervention adequately prevented during the study?

For each included study, we categorised the methods used to blind study participants and personnel from knowledge of which intervention a participant received. Blinding was assessed separately for different outcomes or classes of outcomes. We categorised the methods as:

• low risk, high risk, or unclear risk for participants; and

• low risk, high risk, or unclear risk for personnel.

4. Blinding of outcome assessment (checking for possible detection bias). Was knowledge of the allocated intervention adequately prevented at the time of outcome assessment?

For each included study, we categorised the methods used to blind outcome assessment. Blinding was assessed separately for different outcomes or classes of outcomes. We categorised the methods as:

• low risk for outcome assessors;

• high risk for outcome assessors; or

• unclear risk for outcome assessors.

5. Incomplete outcome data (checking for possible attrition bias through withdrawals, dropouts, protocol deviations). Were incomplete outcome data adequately addressed?

For each included study and for each outcome, we described the completeness of data including attrition and exclusions from the analysis. We noted whether attrition and exclusions were reported, the numbers included in the analysis at each stage (compared with the total randomised participants), reasons for attrition or exclusion when reported, and whether missing data were balanced across groups or were related to outcomes. When sufficient information was reported or supplied by the trial authors, we re‐included missing data in the analyses. We categorised the methods as:

• low risk (< 20% missing data);

• high risk (≥ 20% missing data); or

• unclear risk.

6. Selective reporting bias. Are reports of the study free of suggestion of selective outcome reporting?

For each included study, we described how we investigated the possibility of selective outcome reporting bias and what we found. For studies in which study protocols were published in advance, we compared pre‐specified outcomes versus outcomes eventually reported in the published results. If the study protocol was not published in advance, we contacted study authors to gain access to the study protocol. We assessed the methods as:

• low risk (when it is clear that all of the study's pre‐specified outcomes and all expected outcomes of interest to the review have been reported);

• high risk (when not all of the study's pre‐specified outcomes have been reported; one or more reported primary outcomes were not pre‐specified outcomes of interest and are reported incompletely and so cannot be used; study fails to include results of a key outcome that would have been expected to have been reported); or

• unclear risk.

7. Other sources of bias. Was the study apparently free of other problems that could put it at high risk of bias?

For each included study, we described any important concerns we had about other possible sources of bias (e.g. whether there was a potential source of bias related to the specific study design, whether the trial was stopped early due to some data‐dependent process). We assessed whether each study was free of other problems that could put it at risk of bias as:

• low risk;

• high risk; or

• unclear risk.

If needed, we explored the impact of the level of bias by undertaking sensitivity analyses.

Data and analyses

Comparison 1

Phototherapy with reflective curtains versus phototherapy alone

Analysis

Comparison 1: Phototherapy with reflective curtains versus phototherapy alone, Outcome 4: Rate of decline in bilirubin (micromol/L/h)

Analysis

Comparison 1: Phototherapy with reflective curtains versus phototherapy alone, Outcome 6: Duration of hospital stay (in hours)

Analysis

Comparison 1: Phototherapy with reflective curtains versus phototherapy alone, Outcome 7: Decline in bilirubin at 24 hours (low and high baseline SB)

Comparison 2

Reflective curtains versus intensified phototherapy

Analysis

Comparison 2: Reflective curtains versus intensified phototherapy, Outcome 1: Decline in bilirubin (first measurement)

Analysis

Comparison 2: Reflective curtains versus intensified phototherapy, Outcome 2: Duration of phototherapy (in hours)

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Characteristics of excluded studies [ordered by study ID]

Differences between protocol and review

We made a post hoc decision to include studies comparing reflective curtains with other forms of phototherapy. We included bilirubin at 24 hours as a primary outcome.

As of July 2019, Cochrane Neonatal no longer searches Embase for its reviews. RCTs and controlled clinical trials (CCTs) from Embase are added to the Cochrane Central Register of Controlled Trials (CENTRAL) via a robust process (see How CENTRAL is created). Cochrane Neonatal has validated its searches to ensure that relevant Embase records are found while searching CENTRAL.

Also starting in July 2019, Cochrane Neonatal no longer searches for RCTs and CCTs on the following platforms: ClinicalTrials.gov or the World Health Organization’s International Clinical Trials Registry Platform (ICTRP), as records from both platforms are added to CENTRAL on a monthly basis (see How CENTRAL is created). Comprehensive search strategies are executed in CENTRAL to retrieve relevant records. The ISRCTN (at http://www.isrctn.com/; formerly Controlled‐trials.com) is searched separately.

Contributions of authors

All review authors wrote sections of the protocol, and all provided substantial input into the final draft.

Sources of support

Internal sources

• School of Medical Sciences, Universiti Sains Malaysia, Malaysia

• RCSI & UCD Malaysia Campus (formerly Penang Medical College), Malaysia

• Hospital Seberang Jaya, Penang, Malaysia

• Advanced Medical and Dental Insitute, Universiti Sains Malaysia, Malaysia

External sources

• SEA ORCHID Project, Malaysia

  Training support

• Vermont Oxford Network, USA

  Cochrane Neonatal Reviews are produced with support from Vermont Oxford Network, a worldwide collaboration of health professionals dedicated to providing evidence‐based care of the highest quality for newborn infants and their families.

Declarations of interest

HVR co‐authored two of the RCT studies included in this review (Abd Hamid 2013; Djokomuljanto 2006) (he was the corresponding author for Djokomuljanto 2006). Data from these two studies were extracted independently by LCH and JJH, but some information was supplied by the study author.

IJAH co‐authored one of the RCT studies included in this review (Abd Hamid 2013). Data from this study were extracted independently by LCH and JJH, but some information was supplied by the study author.

JJH has no interest to declare.

CHL has no interest to declare.

References

References to studies included in this review

Abd Hamid 2013 {published data only}

• Abd Hamid IJ, MIyen MI, Ibrahim NR, Abd Majid N, Ramli N, Van Rostenberghe H. Randomised controlled trial of single phototherapy with reflecting curtains versus double phototherapy in term newborns with hyperbilirubinaemia. Journal of Paediatrics and Child Health 2013;49(5):375-9. [DOI: 10.1111/jpc.12192] [PMID: ] [PubMed] [CrossRef] [Google Scholar]

Babaei 2013 {published data only}

• Babaei H, Alipour AA, Hemmati M, Ghaderi M, Rezaei M. Effect of white plastic cover around the phototherapy unit on hyperbilirubinemia in full term neonates. Iranian Journal of Pediatrics 2013;23(2):143-8. [PMID: ] [PMC free article] [PubMed] [Google Scholar]

Dachlan 2015 {published data only}

• Dachlan TI, Yuniati T, Sukadi A. Effect of phototherapy with aluminium foil reflectors on neonatal hyperbilirubinemia. Paediatrica Indonesiana 2015;55(1):13-7. [DOI: 10.14238/pi55.1.2015.18-22] [CrossRef] [Google Scholar]

Devpura 2017 {published data only}

• Devpura K, Swami G, Debbarma R, Udawat P, Jangid A. Effect of low-cost white reflecting sling application on efficacy of phototherapy in healthy term neonates with non-hemolytic jaundice: a randomized controlled trial. Indian Journal of Child Health 2017;4(2):235-8. [Google Scholar]

Djokomuljanto 2006 {published data only}

• Djokomuljanto S, Quah BS, Surini Y, Noraida R, Ismail NZ, Hansen TW, et al. Efficacy of phototherapy for neonatal jaundice is increased by the use of low-cost white reflecting curtains. Archives of Disease in Childhood. Fetal and Neonatal Edition 2006;91(6):F439-42. [DOI: 10.1136/adc.2006.095687] [PMID: ] [PMC free article] [PubMed] [CrossRef] [Google Scholar]

Eggert 1988 {published data only}

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