Devpura 2017.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | Inclusion criteria:
Exclusion criteria:
Mean (SD) age in days at recruitment: Intervention = 2.84 (0.53) Control = 2.96 (0.70) Mean (SD) birth weight in kg of participants: Intervention = 2.78 (0.36) Control = 2.79 (0.26) |
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Interventions | Intervention Experimental group: Single phototherapy with white reflective plastic curtains on 3 sides Control group: Single‐surface phototherapy |
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Outcomes | Fall in SB at the end of 12 hours, 24 hours Rate of fall of serum bilirubin in first 12 hours and between 12 hours and 24 hours Duration of phototherapy (hours) |
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Notes | Study done at a tertiary care institution in Rajasthan, India. SB reported in mg/dL | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "...randomly assigned ... by paper chit method". We judged this description to show unclear risk |
Allocation concealment (selection bias) | Unclear risk | Not reported |
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 | Unclear 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 | Three patients in the intervention group and 4 in the control group excluded from analysis (i.e. 6.5% of participants not included in analysis) |
Selective reporting (reporting bias) | Low risk | Protocol not available. All expected outcomes reported |
Other bias | Low risk | No other source of bias identified |