Gimeno Navarro 2005

Methods	Single centre, randomised controlled trial, conducted in a NICU in Valencia, Spain. Study period: January 2003 to July 2004
Participants	47 ventilated, preterm infants (< 34 weeks' GA) with a haemodynamically significant PDA, confirmed by ECHO in the first week of life and who required respiratory support Ibuprofen: median (25th and 75th centiles) GA 28 (24, 31) weeks; mean (SD) BW 1.169 (490) grams Indomethacin: median (25th and 75th centiles) GA 28.5 (27, 30) weeks; mean (SD) BW 1.206 (513) grams
Interventions	Ibuprofen: 23 infants, ibuprofen 10 mg/kg IV, followed by 2 doses of ibuprofen IV every 24 hours Indomethacin: 24 infants indomethacin 0.2 mg/kg/dose IV every 12 hours for a total of 3 doses
Outcomes	Primary outcome: pharmacological ductal closure Other outcomes: mortality, ductal reopening, need for surgical ligation, NEC, isolated bowel perforation, intestinal haemorrhage, pulmonary haemorrhage, CLD (supplemental oxygen at 28 days), IVH (grades III‐IV), days on assisted ventilation, days in supplemental oxygen, days in NICU
Notes	Study published in Spanish. For the 2014 update of this review, we used Google Translate for Business (Translator Toolkit Website Translator Global Market Finder). No information on funding provided
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation sequence
Allocation concealment (selection bias)	Low risk	Blinding of randomisation ‐ sealed, opaque envelopes
Blinding of participants and personnel (performance bias) All outcomes	High risk	Indomethacin and ibuprofen were given at different time points
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	We could not find information whether the cardiologist performing the ECHOs was blinded to the treatment or not
Incomplete outcome data (attrition bias) All outcomes	Low risk	Complete follow‐up ‐ yes Outcomes reported on all randomised infants
Selective reporting (reporting bias)	Unclear risk	The protocol was not available to us, so we could not judge if there were any deviations
Other bias	Low risk	Appeared free of other bias