| Methods |
Randomised controlled study conducted in the Yuzuncu Yil University, NICU, Van, Turkey. Study period: January 2014 to July 2015 |
| Participants |
Infants < 32 weeks' PMA and with birth weights < 1500 grams and with a haemodynamically significant PDA |
| Interventions |
A total of three ibuprofen doses were administered; the initial dose was 10 mg/kg and the following two doses at 24 and 48 hours were 5 mg/kg. Both rectal and oral ibuprofen were given via an oro‐gastric tube, which was flushed with 1 to 2 ml of sterile water to ensure the delivery of the drug |
| Outcomes |
Failure to close the PDA, need for a 2nd course, need for surgical ligation. Plasma creatinine (mg/dL) after treatment, urine output after treatment, plasma bilirubin (mg/dL) after treatment |
| Notes |
"This manuscript presents independent research funded by Office of Scientific Research Projects of Yuzuncu Yil Unicersity for Health research and Patient Benefit program (Grant reference number 2014‐TF‐B184)" |
| 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 |
"The patients were randomised into treatment groups using numbered cards in sealed envelopes which are not opaque" |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
The infants received either rectal or oral ibuprofen and the administration methods were known to the caregivers. The authors stated: "The limitations of our study included that it was not a double‐blind study and the sample size was relatively small" |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
The infants received either rectal or oral ibuprofen and the administration methods were known to the caregivers. It was not stated whether the cardiologist performing the ECHOs was blinded to the groups or not |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Outcomes reported for all randomised infants. Two infants in the oral ibuprofen group and one infant in the rectal ibuprofen group died before completed treatment; they were not included in a intention‐to‐treat analysis |
| Selective reporting (reporting bias) |
Unclear risk |
The study protocol was not available to us so we could not state if there were any deviations or not |
| Other bias |
Low risk |
Appeared free of other bias |
