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. 2020 Feb 11;2020(2):CD003481. doi: 10.1002/14651858.CD003481.pub8

NCT01758913.

Trial name or title Closure of patent ductus arteriosus with indomethacin or ibuprofen in extreme low‐birth‐weight infants
Methods Randomised controlled trial
Participants Selection criteria: preterm infants with birth weight < 1000 g, radiographic diagnosis of respiratory distress syndrome, requirement of mechanical ventilation, and ECHO and clinical evidence of significant PDA
Interventions Indomethacin: 56 infants, indomethacin 0.2 mg/kg, 0.1 mg/kg and 0.1 mg/kg in 24‐hour interval
Ibuprofen: 54 infants, ibuprofen 10 mg/kg, 5 mg/kg and 5 mg/kg in 24‐hour interval
Outcomes Serum electrolytes, creatinine, renal function (urine output, glomerular filtration rate, fractional excretion of sodium and potassium, osmolar clearance and free water clearance, urinary prostaglandin excretion), pulmonary outcome, and mortality
Starting date February 2007
Contact information Tsu‐Fu Yeh, M.D., Ph.D., Taipei Medical University
Notes ClinicalTrials.gov identifier: NCT01758913
As of January 3, 2013, the recruitment for this study was completed