Filtered-sunlight phototherapy for newborns with moderate-to-severe hyperbilirubinemia: a randomized trial.

Filtered-sunlight phototherapy (FSPT) is safe and non-inferior to conventional phototherapy for treating mild-to-moderate hyperbilirubinemia during birth hospitalization. We evaluated the performance of FSPT among newborns with moderate-to-severe hyperbilirubinemia. Newborns were randomized to FSPT or intensive electric phototherapy (IEPT). Primary outcomes were safety, defined as the absence of hyperthermia, hypothermia, dehydration, or sunburn; and efficacy, defined as the rate of increase in total serum or plasma bilirubin (TSB) < 3.4 µmol/L/h for newborns aged ≤72 h or a decrease in TSB for newborns aged >72 h who received ≥4 h of phototherapy. Secondary outcomes were night-time phototherapy, exchange transfusion (ET), and neonatal mortality rates. Some 104 newborns were assigned to FSPT (n = 52) or IEPT (n = 52). Mean irradiance was 27.7 ± 7.3μW/cm²/nm under FSPT and 36.1 ± 8.3μW/cm²/nm under IEPT. FSPT and IEPT were 93.4% and 93.3% efficacious in all treatment days, respectively. No newborn developed controlled hyperthermia or met the criteria for withdrawal for safety reasons under FSPT. Night-time phototherapy was more frequent under FSPT (52.5%) than IEPT (43.4%). Three neonates (FSPT = 2 and IEPT = 1) had ET. No baby died. Where practicable, FSPT is safe and non-inferior to IEPT for treating neonates with moderate-to-severe hyperbilirubinemia during birth hospitalization when there is no effective IEPT. NCT02612727 (24/11/2015). Filtered-sunlight phototherapy (FSPT) is safe and efficacious for treating newborns with moderate-to-severe hyperbilirubinemia during birth hospitalization. Compared to intensive electric phototherapy, FSPT is not associated with higher rates of exchange transfusion or mortality. The incidence of hazardous hyperbilirubinemia with or without acute bilirubin encephalopathy is rare within 72 h of life in a population with high prevalence of G6PD deficiency and ABO incompatibility risk. In settings where intensive electric phototherapy that meets the recommended minimum irradiance threshold of 30 μW/cm²/nm cannot be assured, FSPT should be considered for at least 4 h for newborns with moderate-to-severe hyperbilirubinemia when practicable.