Lahiri 2016.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | Term infants between 24 hours and 10 days of age, exclusively breastfed, birth weight > 2500 grams, SB < 340 micromol/L. Infants with haemolysis excluded Mean (SD) age in days at recruitment: Intervention = not available Control = not available Mean (SD) birth weight in kg of participants: Intervention = 2.72 (0.37) Control = 2.69 (0.47) |
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Interventions |
Intervention: phototherapy (6 compact light sources ‐ 4 blue and 2 white) with reflective curtains (white cotton sheets with inner reflective surface) Control: phototherapy with a similar phototherapy unit without any curtains |
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Outcomes | SB at 4, 12, and 24 hours Mean SB decline Duration of phototherapy Mean spectral irradiance Adverse effects not reported |
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Notes | Conducted in Calcutta, India, from June 2011 until May 2012 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random sequence after consent obtained |
Allocation concealment (selection bias) | Low risk | "... allocation mailed to researcher after inclusion in the study..." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants: neonates by definition blinded, but parents not blinded. Clinicians/Nurses not blinded. The type of intervention may have influenced handling of the baby by parents and healthcare providers |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Not reported. We judged bilirubin measurement to be an objective measurement not affected by lack of blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Two (out of 100) excluded from control group post randomisation due to G6PD deficiency. All other infants in the study accounted for |
Selective reporting (reporting bias) | Unclear risk | No protocol available. All expected outcomes reported |
Other bias | Low risk | None detected. No adverse effects reported |