Methods |
Randomised controlled trial at Provincial Hospital affiliated to Shandong University, Jinan, China. Study period: July 2011 to December 2011. |
Participants |
Preterm infants with a PDA |
Interventions |
Oral ibuprofen 10 mg/kg, followed by 5 mg/kg after 24 and 48 H, and the placebo group received the same volume of 5% glucose |
Outcomes |
PDA closure at 7 days after treatment |
Notes |
We did not include N‐terminal pro‐brain natriuretic peptide as an outcome. No information on funding provided |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
No information provided |
Allocation concealment (selection bias) |
Unclear risk |
Randomly placed into two groups. No other information provided |
Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
No information provided |
Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
ECHOs were performed by a senior paediatric attending physician, who was unaware of the infants' treatment schedule |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Outcomes reported on all randomised infants |
Selective reporting (reporting bias) |
Unclear risk |
The study protocol was not available to us so we could not judge if there were any deviations or not |
Other bias |
Unclear risk |
Inclusion criteria not well defined and study design not well described |