NCT03265782.
Trial name or title | Comparison between the effect of oral paracetamol versus oral ibuprofen in the treatment of patent ductus arteriosus in preterm and low birth weight infants |
Methods | Randomised open label trial with parallel assignment |
Participants | PMA ≤ 35 weeks, age 2 to 7 days with colour Doppler echocardiographic evidence of PDA, urine output more than 1 mL/kg/h and creatinine concentration level less than 1.8 mg/dl |
Interventions | Ibuprofen administered with a loading dose of 10 mg/kg/day followed by 5 mg/kg/day in 2 doses with 24 h apart for 3 days Paracetamol drug administered for 3 consecutive days in a dose of 15 mg/kg/dose every 6 h |
Outcomes | Echo‐confirmed closure of PDA (time frame: 6 days) |
Starting date | June 2015 |
Contact information | Rania Ali El‐Farrash, Ain Shams University, Cairo, Egypt |
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