Sivanandan 2009.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | Inclusion criteria:
Exclusion criteria:
Single‐unit phototherapy was said to have "failed" if at any time during phototherapy, TSB > 357 μmol/L was documented Mean (SD) of age in days at recruitment: Intervention = 2.70 (1.03) Control = 3.04 (1.83) Mean (SD) birth weight in kg of participants: Intervention = 2.79 (0.35) Control = 2.92 (0.33) |
|
Interventions | Single phototherapy with white plastic reflective curtains vs single phototherapy | |
Outcomes | Mean duration of phototherapy Rate of fall of TSB units/time (μmol/h) for first 8 hours Mean reduction in TSB after 24 hours of phototherapy (mean, SD) Number of exchange transfusions All‐cause mortality |
|
Notes | Study done in New Delhi, India, from October 2005 until March 2007. Adverse effects of phototherapy reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomisation not reported |
Allocation concealment (selection bias) | Low risk | Sealed, sequentially numbered, opaque envelopes used |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants (parents): not blinded. Reflective curtains might inhibit handling of the baby by parents. Clinicians/Nurses not blinded, and reflective curtains might inhibit handling by nurses or parents |
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 | Total of 5 (5.6%) babies excluded from analysis ‐ 2 for intervention group and 3 for control group |
Selective reporting (reporting bias) | Low risk | No protocol available. Based on description of the methods, all planned outcomes apparently reported |
Other bias | Low risk | No other sources of bias detected |
AAP: American Academy of Pediatrics.
ALTE: acute life‐threatening event.
DCT: direct Coombs test.
G6PD: glucose‐6‐phosphate dehydrogenase.
SB: serum bilirubin.
SD: standard deviation.
TSB: total serum bilirubin.