Fish oil infusion may ease lung pressure in fragile newborns
NCT ID NCT04031508
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a special fish-oil emulsion given through an IV can improve outcomes for newborns with a diaphragm defect that causes severe lung pressure. About 40 babies will receive either the fish-oil emulsion or a standard soy-oil one. Researchers will measure lung pressure, oxygen levels, growth, and pain to see if the fish-oil approach helps control the condition better.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2019
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 hour to 15 days
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Unit of Medical Research in Nutrition
Mexico City, Mexico City, 06720, Mexico
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