Clinical Trial

Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH

Study acronym: CDH-PPHN-N3
Enrolling by Invitation Phase 2
View on ClinicalTrials.gov →
Summary
The purpose of this study is to evaluate the effect of a parenteral emulsion containing n-3 long-chain polyunsaturated fatty acids (LC-PUFA) in fish oil on clinical outcomes, markers of inflammation and oxidative stress, and pain in neonates with persistent pulmonary hypertension of the newborn (PPHN) compared with those who receive an emulsion containing soy oil and medium-chain triglycerides (MCT) without n-3 LC-PUFA.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2019-07-22; most recent amendment 2026-03-17.
Status change: Active, Not Recruiting → Enrolling by Invitation 2024-02-21
Status change: Recruiting → Active, Not Recruiting 2023-12-20
Status change: Active, Not Recruiting → Recruiting 2021-03-19
Status change: Recruiting → Active, Not Recruiting 2020-04-11
Status change: Not Yet Recruiting → Recruiting 2020-01-23
Trial Details
NCT Number NCT04031508
Lead Sponsor Coordinación de Investigación en Salud, Mexico
Collaborators: University of Southampton, Universidad Nacional Autonoma de Mexico
Conditions Pulmonary Hypertension of Newborn, Diaphragm Defect
Enrollment 40 participants
Start Date 2019-08-12
Primary Completion 2026-11 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-03-18