Sachdeva 2015.
Study characteristics | ||
Methods | Single‐centre, randomised controlled trial conducted in India | |
Participants |
Inclusion criteria: (quote:) "Healthy" infants > 34 weeks' gestation; hyperbilirubinaemia requiring phototherapy for a minimum of 8 hours Exclusion criteria: (quote:) "Major congenital malformations"; Apgar score < 4 at 5 minutes; onset of jaundice within first 24 hours of life, total serum bilirubin > 18 mg/dL at the time of admission; rise of bilirubin > 0.5 mg/dL/h in the initial 8 hours of starting phototherapy; haemolytic cause of jaundice (positive Coombs’ test, evidence of haemolysis on peripheral smear, reticulocyte count > 6%); total serum bilirubin in exchange range at the time of admission; requiring NICU admission for any reason other than jaundice; direct bilirubin > 15% of total bilirubin; direct bilirubin > 1.5 mg/dL |
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Interventions | Total N = 75 Group 1 (n = 39): continuous phototherapy (phototherapy interrupted for feeding) Group 2 (n = 36): intermittent phototherapy (12 hours on, 12 hours off) Phototherapy was continued until 2 serum bilirubin values measured 12 hours apart < 13 mg/dL |
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Outcomes |
Primary outcome
Secondary outcomes
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Notes | CTRI registration number: CTRI/2014/05/004584 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "the infant was randomized either into intermittent (IPT) or continuous (CPT) group using a computer‐generated random number sequence with 1:1 allocation ratio". |
Allocation concealment (selection bias) | Low risk | Quote: "The site investigator allocated the group by opening serially numbered, opaque, sealed, identical envelopes containing the treatment group allocation". |
Blinding (performance bias and detection bias) All outcomes | Low risk | Unblinded study with objective outcome measures |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Unblinded study with objective outcome measures |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Unblinded study with objective outcome measures |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete outcome data provided for all infants |
Selective reporting (reporting bias) | Unclear risk | Trial registered retrospectively |
Other bias | Low risk | No other potential sources of bias were identified |