Setzer Bandstra 1988.

Study characteristics
Methods	Single‐centre randomized controlled trial
Participants	Inclusion criteria Inborn infants with birth weights of 500 g to 1300 g admitted to the NICU and requiring supplemental oxygen (if study entry was accomplished within 12 hours of birth) Exclusion criteria Terminal condition No parental informed consent Supplemental oxygen not required Grades 2 to 4 IVH on pre study echoencephalogram Major congenital malformation Inability to perform pre study echoencephalogram Overt congenital infection Haemostatic abnormalities Maternal acquired immunodeficiency syndrome.
Interventions	Active intervention (n = 99) IV Indomethacin reconstituted with distilled water to yield 1 mg/mL indomethacin. First dose (0.2mL/kg, i.e. 0.2 mg/kg) given over 15 seconds within 12 hours of birth. Second and third doses (0.1 mL/kg, i.e. 0.1 mg/kg each) given at 12‐hour intervals thereafter. Control (n = 100) Blinded IV placebo
Outcomes	Relevant outcomes for this study included Mortality IVH Treatment for symptomatic PDA Periventricular leukomalacia CLD NEC Oliguria Neurodevelopmental outcome
Notes	Primary study location: University of Miami, USA Study period: February 1983 to June 1985 Trial registration: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomization was effected by drawing consecutive pre coded envelopes
Allocation concealment (selection bias)	Low risk	Patients allocated uses pre coded envelopes
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Identical vials of indomethacin and placebo were prepared by Merck Sharp and Dohme. Investigators unaware of group assignments.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Research personnel unaware of infant treatment assignment reviewed maternal and neonatal records.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Outcomes reported for all randomized infants
Selective reporting (reporting bias)	Unclear risk	It was unclear if there were deviations from the original protocol.
Other bias	Low risk	none noted