Adamska 2005

Methods	Single centre, randomised controlled trial conducted in one NICU in Warsaw, Poland. Study period: not stated
Participants	35 preterm (< 33 weeks' gestation and BW < 1500 grams) infants with a PDA diagnosed by Doppler ECHO Ibuprofen: 16 infants, mean (SD) GA 27.7 (1.8) weeks; BW 1074 (264) grams; 9 boys, 7 girls Indomethacin: 19 infants, mean (SD) GA 27.6 (2.0) weeks; BW 1003 (192) grams; 11 boys, 8 girls
Interventions	Ibuprofen: 3 doses given at 24‐hour intervals (10, 5 and 5 mg/kg IV) Indomethacin: 3 doses given at 24‐hour intervals (0.2 mg/kg/dose IV)
Outcomes	Primary outcome: ductal closure Other outcomes: need for surgical ligation, IVH, PVL, NEC, intestinal perforation, oliguria, time to full oral feeds, CLD (at 28 days of age), pulmonary haemorrhage, pulmonary hypertension, duration of mechanical ventilation, and days in supplemental oxygen
Notes	Study published in Polish. No information about funding of the study
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information other than "...randomly assigned"
Allocation concealment (selection bias)	Low risk	Allocation was done in a blinded fashion
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Ibuprofen and indomethacin were given at the same time intervals
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Staff and researchers were blinded to the group assignment
Incomplete outcome data (attrition bias) All outcomes	Low risk	Complete follow‐up ‐ yes
Selective reporting (reporting bias)	Unclear risk	27 infants (12 received ibuprofen and 15 received indomethacin) were treated as per protocol. In the remaining 8 infants, treatment was stopped due to adverse effects. In the ibuprofen group, the reasons to stop treatment were pulmonary haemorrhage (3/16 infants) and pulmonary hypertension (1/16); in the indomethacin group, it was increased serum creatinine and urea nitrogen concentrations (3/19) and IVH (grade IV) (1/19). The protocol was not available to us so we cannot ascertain if there were any deviations from the protocol or not
Other bias	Low risk	Appeared free of other bias