title: A Randomized Trial of Phototherapy with Filtered Sunlight in African Neonates.
abstract: 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.).
authors.affiliation: From 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.
authors.forename: Tina M
authors.initials: TM
authors.lastname: Slusher
authors.forename: Bolajoko O
authors.initials: BO
authors.lastname: Olusanya
authors.forename: Hendrik J
authors.initials: HJ
authors.lastname: Vreman
authors.forename: Ann M
authors.initials: AM
authors.lastname: Brearley
authors.forename: Yvonne E
authors.initials: YE
authors.lastname: Vaucher
authors.forename: Troy C
authors.initials: TC
authors.lastname: Lund
authors.forename: Ronald J
authors.initials: RJ
authors.lastname: Wong
authors.forename: Abieyuwa A
authors.initials: AA
authors.lastname: Emokpae
authors.forename: David K
authors.initials: DK
authors.lastname: Stevenson
mesh_terms: D000017:ABO Blood-Group System; D001663:Bilirubin / Q000097:blood; D044383:Black People; D005260:Female; D005865:Gestational Age; D006370:Heliotherapy / Q000009:adverse effects / Q000379:methods; D006801:Humans; D051556:Hyperbilirubinemia, Neonatal / Q000628:therapy*; D007231:Infant, Newborn; D008297:Male; D009549:Nigeria; D016896:Treatment Outcome
chemical_list: D000017:ABO Blood-Group System; D001663:Bilirubin