Slusher 2018.

Study characteristics
Methods	Prospective, randomized controlled non‐inferiority trial conducted at Bowen University Teaching Hospital in Ogbomoso, Nigeria – a simulated rural setting. Randomization was computer‐generated, and neither clinicians nor the parents or guardians of participants were blinded to group allocation. Study was conducted from July 2015 through April 2017.
Participants	Eligibility: neonates aged ≤ 14 days or younger who were ≥ 35 weeks' GA or weighed > 2.2 kg if age not known and had TSB at or higher than high risk curve (> 35 weeks) (based on Bhutani 1999), irrespective of actual GA. Infants meeting exchange transfusion requirements could be included at discretion of treating physician. Enrollment: 174 neonates enrolled and randomly assigned: 87 to FSPT group, 87 to IEPT group.
Interventions	Randomly assigned (1:1) to either FSPT or IEPT FSPT: transparent polycarbonate outdoor room with transparent walls and a roof lined with Air blue 80 tinting film that transmitted effective phototherapeutic light, blocked UV light, and reduced infrared radiation. Solar‐powered fans were used to cool the room. IEPT: irradiance at least 30 µW/cm2/nm. Locally designed and constructed IEPT devices. At night and on rainy days, all enrolled infants who met criteria for treatment received IEPT.
Outcomes	Primary Proportion of assessable treatment days (≥ 4 hours of PT, initial and final bilirubin measurements obtained), on which TSB increased by < 3.4 μmol/L/hour if < 72 hours old or decreased if > 72 hours old, and, therefore, was deemed effective. Secondary Absolute change in TSB during the treatment day, rate of change in TSB in each group. Safety Proportion of all treatment days on which neonate not removed for sunburn, dehydration, persistent temperature instability, failure to return to normothermia within 1 hour of being removed from PT. Analysis by intention‐to‐treat with a non‐inferiority margin of 10%
Notes	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 registration number NCT02612727.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Assigned 1:1. Randomization procedure with variable block sizes, assignments were computer generated by study statistician.
Allocation concealment (selection bias)	Low risk	Assignments were printed on sequentially numbered sheets of paper, enclosed in opaque envelopes, sealed, sequentially numbered envelopes, transported to Nigeria by regulatory sponsor. When study nurse enrolled infant she opened the envelope and recorded number and treatment assignment on case report form.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Study was non‐blinded.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Study was non‐blinded.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Only 12/174 infants could not be evaluated. Of treatment days, 149/434 treatment days could not be evaluated, 145 because infant had < 4 hours of PT, and 110 because infant had missing TSB measurement (most of these days had both < 4 hours of PT and a missing TSB measurement). Additionally, 2 days were not evaluated (in 1 infant) because the infant had direct hyperbilirubinemia and so was subsequently excluded from the study. 9 infants were withdrawn after randomization, 5 in the FSPT group (4 by parental request and 1 needed treatment incompatible with PT) and 4 in the IEPT group (2 had direct hyperbilirubinemia, 1 by parental request, and 1 needed treatment incompatible with PT).
Selective reporting (reporting bias)	Low risk	Trial formally registered. All outcomes reported.
Other bias	Low risk	2 infants in the FSPT group received IEPT on 1 treatment day, and 1 infant in the IEPT group received 3 days of FSPT.