By InvitationPhase 2

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

Mexico40 participantsStarted 2019-08-12

Plain-language 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.

Who can participate

Age range

1 Hour – 15 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change on systolic pressure of pulmonary artery

Timeframe: Before surgery (baseline), 24 hour, 48 hour, 72 hour, day 7, day 14 and day 21 post-surgery.

Preductal partial pressure of carbon (PaCO2)

Timeframe: Before surgery (baseline), 24 hour, 48 hour, 72 hour and day 7 post-surgery.

Change in Preductal and postductal oxygen saturation (SatO2)

Timeframe: Before surgery (baseline), 24 hour, 48 hour, 72 hour, day 7, day 14 and day 21 post-surgery.

Inspired fraction of oxygen (FiO2)

Timeframe: Before surgery (baseline), 24 hour, 48 hour, 72 hour, day 7, day 14 and day 21 post-surgery.

Growth velocity and Nutritional status

Timeframe: Before surgery (baseline), day 7, day 14 and day 21 post-surgery.

Pain manifestation

Timeframe: Before surgery (baseline), 24 hour, 48 hour, 72 hour, day 7, day 14 and day 21 post-surgery.

Trial details

NCT IDNCT04031508

SponsorCoordinación de Investigación en Salud, Mexico

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2026-11

View on ClinicalTrials.gov More Pulmonary Hypertension of Newborn trials

Plain-language summary

Who can participate

Age range

1 Hour – 15 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change on systolic pressure of pulmonary artery

Timeframe: Before surgery (baseline), 24 hour, 48 hour, 72 hour, day 7, day 14 and day 21 post-surgery.

Preductal partial pressure of carbon (PaCO2)

Timeframe: Before surgery (baseline), 24 hour, 48 hour, 72 hour and day 7 post-surgery.

Change in Preductal and postductal oxygen saturation (SatO2)

Timeframe: Before surgery (baseline), 24 hour, 48 hour, 72 hour, day 7, day 14 and day 21 post-surgery.

Inspired fraction of oxygen (FiO2)

Timeframe: Before surgery (baseline), 24 hour, 48 hour, 72 hour, day 7, day 14 and day 21 post-surgery.

Growth velocity and Nutritional status

Timeframe: Before surgery (baseline), day 7, day 14 and day 21 post-surgery.

Pain manifestation

Timeframe: Before surgery (baseline), 24 hour, 48 hour, 72 hour, day 7, day 14 and day 21 post-surgery.