Slusher TM, et al. - Researchers conducted a prospective, randomized, controlled non-inferiority trial in Nigeria to compare the efficacy and safety of filtered-sunlight phototherapy (FSPT) to intensive electric phototherapy (IEPT) in neonates with clinically significant, moderate-to-severe hyperbilirubinemia. Findings indicated that, for the treatment of moderate-to-severe neonatal hyperbilirubinemia in near-term and term infants, FSPT is safe and no less efficacious than IEPT.

Methods

• Near-term or term infants aged ≤ 14 days who were of 35 weeks or more gestational age and with total serum bilirubin concentrations at or above the recommended age-dependent treatment levels for high-risk neonates were randomized (1:1) to either FSPT or IEPT.
• Randomization was computer-generated, and neither physicians nor the parents or guardians of study participants were masked to group allocation.
• FSPT was delivered in a transparent polycarbonate room lined with commercial tinting films that transmitted effective phototherapeutic light, blocked ultraviolet light, and decreased infrared radiation.
• Efficacy was the primary outcome, which was based on assessable treatment days only (ie, those on which ≥ 4 hours of phototherapy was delivered) and characterized as a rate of increase in total serum bilirubin concentrations of less than 3.4 μmol/L/h in infants aged ≤ 72 hours, or a decrease in total serum bilirubin concentrations in those aged > 72 hours.
• Safety was characterized as no sustained hypothermia, hyperthermia, dehydration, or sunburn and was based on all treatment days.
• Analysis was by intention to treat with a non-inferiority margin of 10%.

Results

• A total of 174 neonates were enrolled and randomized: 87 to FSPT and 87 to IEPT between July 31, 2015, and April 30, 2017.
• Researchers found that neonates in the FSPT group received 215 days of phototherapy, 82 (38%) of which were not assessable.
• In addition, neonates in the IEPT group received 219 treatment days of phototherapy, 67 (31%) of which were not assessable.
• It was noted that median irradiance was 37.3 μW/cm²/nm (interquartile range: 21.4–56.4) in the FSPT group and 50.4 μW/cm²/nm (44.5–66.2) in the IEPT group.
• FSPT was efficacious on 116 (87.2%) of 133 treatment days.
• IEPT was efficacious on 135 (88.8%) of 152 treatment days (mean difference: -1·6%; 95% CI: -9·9 to 6·7; P=0.8165).
• FSPT was not inferior to IEPT because the CI did not extend below -10%.
• For all neonates, treatment was safe.