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A Randomized Trial of Phototherapy with Filtered Sunlight in African Neonates
Tina M Slusher1, Bolajoko O Olusanya, Hendrik J Vreman
1From the Department of Pediatrics (T.M.S., T.C.L.) and the Biostatistical Design and Analysis Center, Clinical and Translational Science Institute (A.M.B.), University of Minnesota, and Hennepin County Medical Center (T.M.S.) - both in Minneapolis; Center for Healthy Start Initiative (B.O.O.) and Massey Street Children's Hospital (A.A.E.), Lagos, Nigeria; and Department of Pediatrics, Stanford University, Stanford (H.J.V., R.J.W., D.K.S.), and the University of California, San Diego, San Diego (Y.E.V.) - both in California.
Insights
Filtered sunlight is a safe and effective alternative to conventional phototherapy for treating neonatal hyperbilirubinemia, especially where resources are limited. This study found filtered sunlight to be noninferior to conventional methods.
Area of Science:
- Neonatal care
- Phototherapy
- Public health
Background:
- Severe neonatal hyperbilirubinemia poses a significant health risk in resource-limited settings.
- Filtered sunlight has shown promise as a safe and effective phototherapy method.
- Comparative safety and efficacy against conventional phototherapy remained unknown.
Purpose of the Study:
- To compare the efficacy and safety of filtered sunlight versus conventional phototherapy for neonatal hyperbilirubinemia.
- To determine if filtered sunlight is noninferior to conventional phototherapy.
Main Methods:
- A randomized, controlled noninferiority trial was conducted in Nigeria.
- 447 term and late-preterm neonates with hyperbilirubinemia were enrolled.
- Efficacy was defined by bilirubin level changes; safety by absence of adverse events requiring therapy withdrawal.
Main Results:
- Filtered sunlight was efficacious on 93% of treatment days compared to 90% for conventional phototherapy.
- Filtered sunlight provided higher irradiance (40 vs. 17 μW/cm²/nm).
- No significant safety concerns or need for exchange transfusion arose in either group.
Conclusions:
- Filtered sunlight is noninferior to conventional phototherapy for treating neonatal hyperbilirubinemia.
- Filtered sunlight demonstrated comparable safety, with no study withdrawals due to adverse events.
- This approach offers a viable alternative in areas lacking conventional phototherapy.
Background:
Sequelae of severe neonatal hyperbilirubinemia constitute a substantial disease burden in areas where effective conventional phototherapy is unavailable. We previously found that the use of filtered sunlight for the purpose of phototherapy is a safe and efficacious method for reducing total bilirubin. However, its relative safety and efficacy as compared with conventional phototherapy are unknown.
Methods:
We conducted a randomized, controlled noninferiority trial in which filtered sunlight was compared with conventional phototherapy for the treatment of hyperbilirubinemia in term and late-preterm neonates in a large, urban Nigerian maternity hospital. The primary end point was efficacy, which was defined as a rate of increase in total serum bilirubin of less than 0.2 mg per deciliter per hour for infants up to 72 hours of age or a decrease in total serum bilirubin for infants older than 72 hours of age who received at least 5 hours of phototherapy; we prespecified a noninferiority margin of 10% for the difference in efficacy rates between groups. The need for an exchange transfusion was a secondary end point. We also assessed safety, which was defined as the absence of the need to withdraw therapy because of hyperthermia, hypothermia, dehydration, or sunburn.
Results:
We enrolled 447 infants and randomly assigned 224 to filtered sunlight and 223 to conventional phototherapy. Filtered sunlight was efficacious on 93% of treatment days that could be evaluated, as compared with 90% for conventional phototherapy, and had a higher mean level of irradiance (40 vs. 17 μW per square centimeter per nanometer, P<0.001). Temperatures higher than 38.0°C occurred in 5% of the infants receiving filtered sunlight and in 1% of those receiving conventional phototherapy (P<0.001), but no infant met the criteria for withdrawal from the study for reasons of safety or required an exchange transfusion.
Conclusions:
Filtered sunlight was noninferior to conventional phototherapy for the treatment of neonatal hyperbilirubinemia and did not result in any study withdrawals for reasons of safety. (Funded by the Thrasher Research Fund, Salt Lake City, and the National Center for Advancing Translational Sciences of the National Institutes of Health; Clinical Trials.gov number, NCT01434810.).
