Trial name or title | No treatment versus ibuprofen treatment for patent ductus arteriosus in preterm infants |
Methods | Randomised controlled trial |
Participants | Infants with a gestational age of ≤ 30 weeks or birth weight of ≤ 1250 grams confirmed to have haemodynamically significant PDA during day of life 7 to 14 |
Interventions | Ibuprofen: initial dose of oral ibuprofen 10 mg/kg, followed by 2 doses of 5 mg/kg 24 and 48 hours later Saline: normal saline followed by second and third dose 24 and 48 hours later, at equal volume to ibuprofen |
Outcomes | Incidence of moderate‐to‐severe bronchopulmonary dysplasia or mortality at 36 weeks' PMA (time frame 36 weeks' PMA) |
Starting date | July 2014 |
Contact information | Contact: Se In Sung, M.D.; phone: 82‐2‐3410‐1775; sein.sung@samsung.com |
Notes | ClinicalTrials.gov Identifier: NCT02128191 As of October 14, 2016, this study was still recruiting |