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. 2021 Jul 6;2021(7):CD013277. doi: 10.1002/14651858.CD013277.pub2

Slusher 2015.

Study characteristics
Methods Randomized, controlled non‐inferiority trial in which filtered sunlight was compared with CPT for the treatment of hyperbilirubinemia in term and late preterm neonates at Island Maternity Hospital in Lagos, Nigeria, from November 2012 to September 2013.
Participants Eligibility: all infants up to 14 days of age at > 35 weeks' gestation (or > 2.2 kg BW if GA unknown), black Africans, with elevated serum bilirubin (defined as 3 mg/dL below the level recommended by the AAP (based on Bhutani 1999), to begin PT in high‐risk infants)
Enrollment: 447 term and late preterm neonates enrolled and randomly assigned; 224 to filtered sunlight, 223 to CPT
Interventions Filtered sunlight compared with CPT.
  • Filter was Film canopy Air Blue 80 if sky was overcast (84% blue light passage) or Film canopy Gila Titanium if sky was sunny (39% blue light passage)

  • CPT with locally available materials, irradiance 8–10 µW/cm2/nm


At night and on rainy days, all enrolled infants who met criteria for treatment received CPT.
Outcomes Primary
  • Proportion of safe days when a given therapy was used in which the therapy was efficacious (based on rate of change of serum bilirubin, rise no greater than 0.2 mg/dL if < 72 hours old, decrease if > 72 hours old). Non‐inferiority margin 10%


Secondary
  • Proportion of infants requiring exchange transfusion. Non‐inferiority margin 5%


Safety monitoring
  • Hyperthermia

  • Hypothermia

  • Dehydration

  • Sunburn

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 number, NCT01434810.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomly assigned using a block randomization procedure, with block sizes of 2, 4, 6, 8, and 10.
Allocation concealment (selection bias) Low risk Treatment assignments were recorded on sequentially numbered sheets of paper, enclosed in opaque, sealed, matching, numbered envelopes, and shipped to Lagos and opened sequentially for each enrolled infant.
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 13/220 infants could not be evaluated (4 had missing time under PT, 6 received < 5 hours of PT, 4 had missing afternoon bilirubin assessments).
No infant in either group met criteria for withdrawal due to safety.
Selective reporting (reporting bias) Low risk Trial formally registered. All outcomes reported.
Other bias Low risk 2 mothers of infants in CPT group requested their infants be switched to FSPT on the last day of treatment.