Abd Hamid 2013.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | Inclusion criteria:
Exclusion criteria:
Mean (SD) age in days at recruitment: Intervention = 5.12 (2.09) Control = 5.82 (6.85) Mean (SD) body weight in kg of participants: Intervention = 3.08 (0.44) Control = 3.06 (0.37) |
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Interventions | Single phototherapy with reflective curtains (n = 78) vs double phototherapy (n = 78) | |
Outcomes | Mean decrease in SB after 4 hours phototherapy (n = 153, excluding 3 requiring exchange transfusion) (data not included in the analysis) Mean decrease in SB after 4 hours phototherapy (n = 156, including 3 requiring exchange transfusion) (data included in the analysis) Mean decrease in SB after 10 hours phototherapy (n = 153) Duration of phototherapy Number of exchange transfusions within neonatal period All‐cause mortality at discharge (provided by study authors) Acute life‐threatening event (ALTE) during phototherapy (provided by study authors) Side effects including hypothermia, hyperthermia, dehydration, weight loss, skin rash, bronze discolouration, changes in stool frequency |
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Notes | Comparison of duration of phototherapy done with Cox proportional hazard. No median value mentioned in the article. Information on mean and SD value of SB at 24 hours and duration of phototherapy given by primary author of the study. Single‐centre study done in Kelantan, Malaysia, from May 2010 to April 2011 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Block randomisation, based on a computer generated table, was used for the randomisation of all subjects into either of two groups (control group = double phototherapy, intervention group = single phototherapy with reflecting curtains)" |
Allocation concealment (selection bias) | Low risk | "Only after inclusion in the study, consecutively numbered, sealed and opaque envelopes, carrying the allocation, were opened" |
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 by healthcare providers |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Laboratory staff blinded to the study (reported in article); bilirubin measurement objective Comment: we judged that lack of blinding of participants and staff would be unlikely to have an effect on the outcomes reported (changes in bilirubin levels) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Both per‐protocol analysis and intention‐to‐treat analysis reported. Follow‐up complete |
Selective reporting (reporting bias) | Low risk | No protocol available. All expected outcomes and all outcomes outlined in the methods reported |
Other bias | Low risk | No other sources of significant bias identified |