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 |
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Interventions | Filtered sunlight compared with CPT.
At night and on rainy days, all enrolled infants who met criteria for treatment received CPT. |
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Outcomes |
Primary
Secondary
Safety monitoring
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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. |