Pourarian 2015.
Methods | Randomised controlled trial conducted in the Neonatology Research Center, Shiraz Univeristy Medical Sciences, Shiraz, Iran. Study period: April 2012 to May 2013 | |
Participants | Preterm infants with PMA < 37 weeks and postnatal age 3 to 7 days with ECHO diagnosis of a haemodynamically significant PDA | |
Interventions | Group I (high‐dose ibuprofen group) received 20 mg/kg PO ibuprofen as first dose followed by 10 mg/kg/dose after 24 and 48 hours Group II (normal‐dose ibuprofen group) received 10 mg/kg PO ibuprofen as first dose followed by 5 mg/kg/dose after 24 and 48 hours |
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Outcomes | Primary: Failure to close the PDA after the first course and after the second course. Secondary: Surgical ligation, ROP, bleeding disorders, GI bleeding, NEC, pulmonary haemorrhage, IVH (all grades) mortality, oliguria, serum BUN (mmol/L) after treatment, serum creatinine (mg/dL) after treatment, urine output (mL/kg/hr) after treatment, platelet count | |
Notes | No external funding was secured for this study | |
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 | Cards in sealed opaque envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information provided |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The cardiologist performing the ECHOs was unaware of the infants' treatment assignments |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcome data provided for all randomised infants |
Selective reporting (reporting bias) | Unclear risk | The protocol for the study was not available to us so we could not judge if there were any deviations from the protocol or not |
Other bias | Low risk | Appeared free of other bias |