Arnold 2020.
Study characteristics | ||
Methods | Multicentre, randomised controlled trial conducted in USA | |
Participants |
Inclusion criteria: birth weight 401 to 1000 grams; postnatal age < 24 hours; receiving full medical support Exclusion criteria: previously received phototherapy; known haemolytic disease; overt nonbacterial infection; major anomaly; moribund (pH < 6.8 for > 2 hours or persistent bradycardia < 100 beats per minute associated with hypoxia for > 2 hours) |
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Interventions | Total N = 305 Group 1 (n = 137): intermittent phototherapy (15 minutes or more per hour, adjusted based on daily total serum bilirubin levels) Group 2 (n = 34): intermittent phototherapy (30 minutes or more per hour, adjusted based on daily total serum bilirubin levels) Group 3 (n = 134): continuous phototherapy Infants in all groups received phototherapy when the total serum bilirubin was ≥ 5.0 mg/dL during the first 14 days of life (infants 751 to 1000 grams ≥ 7.0 mg/dL days 8 to 14) |
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Outcomes |
Primary outcomes
Reported outcomes
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Notes | clinicaltrials.gov identifier: NCT01944696 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Participants were ... randomized using a variable block size and a web‐based computerized program (REDCap)". |
Allocation concealment (selection bias) | Low risk | Quote: "Participants were ... randomized using a variable block size and a web‐based computerized program (REDCap)". |
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 | Quote: "The BAERs were assessed by a single evaluator (A.D.) using carefully standardized methods and blinded to treatment group". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete outcome data provided for all infants |
Selective reporting (reporting bias) | High risk | Primary outcomes reported did not match primary and secondary outcomes in trial registry. NCT01944696: Cycled phototherapy: a safer effective treatment for small premature infants? clinicaltrials.gov/ct2/show/NCT01944696 (first received 18 September 2013). |
Other bias | Low risk | No other potential sources of bias were identified. |