NCT02128191

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

Completed Phase 2 Last updated 9 January 2020

What this trial tests

Phase 2 trial testing Oral ibuprofen in Bronchopulmonary Dysplasia (BPD) in 142 participants. Completed in 1 August 2019.

Timeline

1 July 2014

Primary endpoint
1 August 2019

1 August 2019

Quick facts

Lead sponsor	Samsung Medical Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	142
Start date	1 July 2014
Primary completion	1 August 2019
Estimated completion	1 August 2019
Sites	1 location across South Korea

Drugs / interventions tested

• Oral ibuprofen
• Normal saline

Conditions studied

• Bronchopulmonary Dysplasia (BPD) — all drugs for Bronchopulmonary Dysplasia (BPD) →

Sponsor

Samsung Medical Center

Who can join

Adults 5 Days to 14 Days, any sex, with Bronchopulmonary Dysplasia (BPD). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Incidence of moderate to severe bronchopulmonary dysplasia (BPD) or mortality at 36 weeks postmenstrual age (PMA)
  Time frame: 36 weeks PMA

Sponsor's own description

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)

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Relationship between Duration of Infant Exposure to a Moderate-to-Large Patent Ductus Arteriosus Shunt and the Risk of Developing Bronchopulmonary Dysplasia or Death Before 36 Weeks.
   Clyman RI, Hills NK, Liebowitz M, Johng S. · · 2020 · cited 66× · PMID 31600791 · DOI 10.1055/s-0039-1697672
2. Ibuprofen for the treatment of patent ductus arteriosus in preterm or low birth weight (or both) infants.
   Ohlsson A, Walia R, Shah SS. · · 2020 · cited 60× · PMID 32045960 · DOI 10.1002/14651858.cd003481.pub8
3. Effect of Nonintervention vs Oral Ibuprofen in Patent Ductus Arteriosus in Preterm Infants: A Randomized Clinical Trial.
   Sung SI, Lee MH, Ahn SY, Chang YS, et al · · 2020 · cited 59× · PMID 32539121 · DOI 10.1001/jamapediatrics.2020.1447
4. Ibuprofen for the treatment of patent ductus arteriosus in preterm or low birth weight (or both) infants.
   Ohlsson A, Walia R, Shah SS. · · 2018 · cited 43× · PMID 30264852 · DOI 10.1002/14651858.cd003481.pub7
5. Treatment and Nontreatment of the Patent Ductus Arteriosus: Identifying Their Roles in Neonatal Morbidity.
   Clyman RI, Liebowitz M. · · 2017 · cited 19× · PMID 28709633 · DOI 10.1016/j.jpeds.2017.06.054