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. 2023 Mar 2;2023(3):CD008168. doi: 10.1002/14651858.CD008168.pub2

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)
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)
Outcomes Primary outcomes
  • Mean peak total serum bilirubin levels

  • Mean phototherapy hours


Reported outcomes
  • Death and major predischarge morbidities, including:

    • severe (grade 3 or 4) intraventricular haemorrhage;

    • bronchopulmonary dysplasia;

    • surgical necrotising enterocolitis;

    • patent ductus arteriosus requiring treatment;

    • severe retinopathy of prematurity (stage 3 or higher or plus disease);

    • late onset sepsis.

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.