Fakhraee 2007.
Methods | Single centre randomised controlled trial in Tehran, Iran. Study period: June 2003 to June 2004 | |
Participants | 36 preterm infants PMA < 34 weeks, aged ≤ 14 days, platelet count > 100,000/μL, serum creatinine ≤ 1.6 mg/dL, absence of clinical manifestations of abnormal clotting function, absence of grades III‐IV IVH. Colour Doppler ECHO evidence of significant PDA Ibuprofen: 18 infants, mean (SD) PMA 31.5 (1.4) weeks; BW 1658 (387) grams Indomethacin: 18 infants, mean (SD) PMA 30.9 (2.0) weeks; BW 1522 (358) grams Study period: June 2003 to June 2004 |
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Interventions | Ibuprofen: orally as a suspension at a first dose of 10 mg/kg, followed at an interval of 24 hours by 2 doses of 5 mg/kg Indomethacin: orally 3 times at 0.2 mg/kg/dose at intervals of 24 hours |
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Outcomes | Ductal closure, need for re‐treatment, reopening of the duct, mortality during the first 30 days of life, maximum serum BUN and creatinine levels, NEC, IVH (grades III‐IV), oliguria | |
Notes | No information on funding provided | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No description provided |
Allocation concealment (selection bias) | Unclear risk | No description provided. "The enrolled patients randomly received either oral ibuprofen or oral indomethacin" |
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 paediatric cardiologist, who was blinded to the infants' treatment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcomes were reported for all enrolled 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 |