NCT05493540

Oral Ibuprofen Versus Placebo in Treatment of Patent Ductus Arteriosus (PDA)in Preterm Infants

Completed Phase 2 Last updated 28 February 2023

What this trial tests

Phase 2 trial testing Ibuprofen oral suspension in Patent Ductus Arteriosus After Premature Birth in 80 participants. Completed in 1 September 2022.

Timeline

15 April 2021

Primary endpoint
15 August 2022

1 September 2022

Quick facts

Lead sponsor	Nada Youssef
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	80
Start date	15 April 2021
Primary completion	15 August 2022
Estimated completion	1 September 2022
Sites	1 location across Egypt

Drugs / interventions tested

• Ibuprofen oral suspension
• Placebo

Conditions studied

• Patent Ductus Arteriosus After Premature Birth — all drugs for Patent Ductus Arteriosus After Premature Birth →
• Patent Ductus Arteriosus Conservative Management — all drugs for Patent Ductus Arteriosus Conservative Management →

Sponsor

Nada Youssef

Who can join

Adults 1 Hour to 7 Days, any sex, with Patent Ductus Arteriosus After Premature Birth or Patent Ductus Arteriosus Conservative Management. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The management options of Patent Ductus Arteriosus are still controversial and differ between centers. Recently, conservative management has been gaining interest as the evidence of benefit from medical treatment in terms of mortality and morbidity is lacking.

This study will compare oral ibuprofen (the standard treatment) with the conservative treatment, in terms of ductal closure and morbidity and mortality at discharge in preterm neonates less than 34 weeks.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The molecular mechanisms of cardiac development and related diseases.
   Li Y, Du J, Deng S, Liu B, et al · · 2024 · cited 53× · PMID 39715759 · DOI 10.1038/s41392-024-02069-8