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ENROLLING BY INVITATION
NCT04031508
PHASE2

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

Sponsor: Coordinación de Investigación en Salud, Mexico

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.

Official title: Effect of a Parenteral Emulsion With LC-PUFA Omega 3 on Clinical Outcomes, Inflammatory and Oxidative Stress Markers in Neonates With Persistent Pulmonary Hypertension Associated With Congenital Diaphragmatic Hernia

Key Details

Gender

All

Age Range

1 Hour - 15 Days

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2019-08-12

Completion Date

2026-12

Last Updated

2026-03-18

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

lipid injectable emulsion with Fish oil

TPN will start at 1.5-2.0 g/kg/d of the lipid emulsion, increasing 1.0 g/kg/d until a maximum of 3.0 g/kg/d for at least 7 days.

Locations (1)

Unit of Medical Research in Nutrition

Mexico City, Mexico City, Mexico