NCT02128191

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

Efficacy and Safety of No Treatment Compared With Oral Ibuprofen Treatment for Patent Ductus Arteriosus in Preterm Infants: a Randomized, Double-blind, Placebo-controlled, Non-inferiority Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 5 Days – 14 Days
• Healthy volunteers: Not accepted

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)

Detailed description

This study is a randomized, double-blind, placebo-controlled, non-inferiority clinical trial.

Conditions

• Bronchopulmonary Dysplasia (BPD)

Interventions

Type	Name	Description
DRUG	Oral ibuprofen	Initial dose of 10 mg/kg of oral ibuprofen, followed by two doses of 5 mg/kg 24 and 48 hours later
DRUG	Normal saline	Initial dose of normal saline followed by second and third dose 24 and 48 hours later, at equal volume to ibuprofen arm

Timeline

• Start date: 2014-07-01
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2014-05-01
• Last updated: 2020-01-13

Locations

1 site across 1 country: South Korea