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

Enrolling by invitation · Phase 2

Conditions studied: Pulmonary Hypertension of Newborn, Diaphragm Defect

In brief

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.

Key facts

Study ID

NCT04031508

Run by

Coordinación de Investigación en Salud, Mexico

People needed

40

Starts

2019-08-12

Expected to finish

2026-12-01

Last updated by the study team

2026-03-18

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Plan to administrate TPN for at least 7 days
• Clinical, gasometric, and echocardiographic diagnosis of congenital diaphragmatic hernia.
• Gestational age >=34 weeks.
• Written informed consent signed by both parents after an explanation of the objectives, procedures and possible risks and benefits of the research, along with the signature of two witnesses

You may not qualify if…

• Diagnosis of complex congenital cardiopathy
• Cyanotic congenital cardiology defect
• Insufficiency of the tricuspid valve
• Immunosuppressive disease. HIV has been associated with PPHN and human herpesvirus with vascular remodeling, perivascular macrophages, and lung fibrosis
• Clinical entities that preclude the total parenteral nutrition for one day or longer.
• Presence of profuse and persistent haemorrhage at any level
• Elimination criteria
• Parents who withdraw their consent.
• Starting a drug at doses for nonclotting treatment such as heparin, enoxaparin.
• Development of profuse and persistent haemorrhage at any level after receiving vitamin K treatment.

Where it is running

• Unit of Medical Research in Nutrition — Mexico City, Mexico City, Mexico

Full record on ClinicalTrials.gov

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