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 |