Dani 2000.

Study characteristics
Methods	Two‐centre randomized controlled trial
Participants	Inclusion criteria GA < 34 weeks Treatment with nasal continuous positive airway pressure with FiO2 > 0.3 or with mechanical ventilation (synchronised mechanical ventilation or high‐frequency ventilation) due to RDS Platelet count ≥ 75,000/cm, serum creatinine ≤ 1.5 mg/dL, absence of clinical manifestation of abnormal clotting function Absence of grade 3 or 4 IVH before randomisation Enrolled within first 24 hours after birth Exclusion criteria Major congenital malformations including congenital heart defects, persistent pulmonary hypertension of the newborn or hydrops fetalis
Interventions	Active intervention (n = 40) Prophylactic IV ibuprofen lysine (Arfen, Lisapharma, Italy) 10 mg/kg within first 24 hours of life, followed by 5 mg/kg after 24 and 48 hours Control (n = 40) The control group received no prophylactic therapy. The control group received same pharmacological treatment after echocardiographic diagnosis of PDA
Outcomes	Relevant outcomes for this study included Mortality IVH CLD (oxygen supplementation beyond 28 days) NEC Treatment for symptomatic PDA Surgical PDA ligation
Notes	Primary study location: Careggi University Hospital of Florence and Sant'Anna University Hospital of Turin, Italy Study period: February 1995 to January 1996 Trial registration: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Sequence generation method not specified.
Allocation concealment (selection bias)	Low risk	sealed envelope technique used
Blinding of participants and personnel (performance bias) All outcomes	High risk	No placebo and no indication of blinding efforts
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	It is unclear if the assessors for reported outcomes were blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Outcomes reported for all enrolled infants.
Selective reporting (reporting bias)	Unclear risk	Study protocol was unavailable. Unclear if there were any deviations from the protocol.
Other bias	Low risk	Appeared free of other bias.