Cherif 2008.
| Methods | Single centre, randomised controlled trial. Conducted in the NICU of the Neonatal and Maternity Center of Tunis, Tunis, Tunisia. Study period: one year, January 2007 to December 2007 | |
| Participants | 64 VLBW infants with ECHO‐confirmed PDA, PMA < 32 weeks, BW < 1500 grams, postnatal age 48 to 96 hours, respiratory distress requiring > 25% oxygen supplementation and ECHO evidence of significant left‐to‐right shunting across PDA | |
| Interventions | Ibuprofen (oral): 32 infants, oral ibuprofen 10 mg/kg as the initial dose Ibuprofen (IV): 32 infants, IV ibuprofen 10 mg/kg as the initial dose After the first dose of treatment in both groups, ECHO evaluation was performed to determine the need for a second or a third dose. In each group, in case the ductus was still open after the third dose, IV ibuprofen (an initial dose of 10 mg/kg followed by 2 doses of 5 mg/kg each, after 24 and 48 hours) as a non‐randomised rescue treatment was given. If this therapy did not promote ductal closure and the infant continued to receive mechanical ventilation, surgical ligation of the ductus was performed |
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| Outcomes | PDA closure rate, need for surgical ligation, rate of reopening of the ductus, oliguria, increase in serum creatinine level > 16 mg/dL, change in creatinine concentrations, IVH grades I‐II and grades III‐IV, PVL, NEC, bowel perforation, sepsis, duration of intubation, survival at 1 month, and duration of hospital stay | |
| Notes | 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) | Low risk | Infants were randomly assigned to a treatment group by means of cards in sealed, opaque envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Health care providers were not blinded to treatment groups |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Physicians performing ECHO and making the decision for second and third dose administration were unaware of assignment |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcomes reported for all enrolled infants |
| Selective reporting (reporting bias) | Low risk | The protocol was available to us. Trial number: NCT00642330. There did not seem to be any definitive deviations from the protocol |
| Other bias | Low risk | Appeared free of other bias |