No Treatment Versus Oral Ibuprofen Treatment for Patent Ductus Arteriosus in Preterm Infants

Summary

The purpose of this study is to evaluate the efficacy and safety of no treatment compared with ibuprofen treatment for patent ductus arteriosus in preterm infants. The study hypothesis is that no treatment is not inferior to oral ibuprofen treatment in preterm infants. (non-inferiority study)

Timeline

Start

2014-07

Primary completion

2019-08

Completion

2019-08

Publications

• Sung SI, Lee MH, Ahn SY, Chang YS, Park WS. Effect of Nonintervention vs Oral Ibuprofen in Patent Ductus Arteriosus in Preterm Infants: A Randomized Clinical Trial. JAMA Pediatr. 2020 Aug 1;174(8):755-763. doi: 10.1001/jamapediatrics.2020.1447.

Drugs

Indications