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

Romagnoli 1976.

Study characteristics
Methods Single‐centre, randomised controlled trial conducted in Italy
Participants Inclusion criteria: quote: "Preterm newborn infants" (gestation not specified)
Exclusion criteria: severe respiratory disease; haemolytic conditions; septic conditions; malformation
Interventions Total N = 90 
Group I (n = 31): no intervention (exchange transfusion if required)
Group II (n = 31): continuous phototherapy (started day 1 of life, stopped day 5 of life (average 96 hours))
Group III (n = 28): intermittent phototherapy (12 hours on, 12 hours off; started day of life, stopped day 7 of life (total 72 hours of phototherapy))
Outcomes Primary outcome
  • (quote:) "Somatic development during the first four weeks of life"


Reported outcomes
  • Daily bilirubin level for first 7 days of life

  • Bilirubin level > 12 mg/dL

  • Bilirubin level > 15 mg/dL

  • Exchange transfusion

  • Weekly weight and head circumference for first 4 weeks of life

Notes Article in Italian
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Sequence generation not described ((quote:) "Subjects included in the study were assigned 'randomly' to one of the three study groups").
Allocation concealment (selection bias) Unclear risk Allocation concealment not described ((quote:) "Subjects included in the study were assigned 'randomly' to one of the three study groups").
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 Unclear risk Completeness of data not specified
Selective reporting (reporting bias) Unclear risk Study protocol not available
Other bias Low risk No other potential sources of bias were identified.