drugset / Trial / NCT04031508
Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH
Phase 2
Enrolling by invitation
40 enrolled
Coordinación de Investigación en Salud, Mexico
Universidad Nacional Autonoma de Mexico · collabUniversity of Southampton · collab
RandomizedParallel-groupTriple-blindPrevention
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.
Timeline
- Start
- 2019-08-12
- Primary completion
- 2026-11
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SMOFlipid | Other / unclassified | 3 g/kg | Intravenous |