NCT04031508Active, not recruitingPhase 2
Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH
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
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 8 Jul 2019
- Start date
- 12 Aug 2019
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- NCT number
- NCT04031508
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 12 Aug 2019 to the primary completion date, 1 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Insufficiency of the tricuspid valve
- Immunosuppressive disease. HIV has been associated with PPHN and human herpesvirus with vascular remodeling, perivascular macrophages, and lung fibrosis
- Presence of profuse and persistent haemorrhage at any level
- Elimination criteria
Other
- Diagnosis of complex congenital cardiopathy
- Cyanotic congenital cardiology defect
- Clinical entities that preclude the total parenteral nutrition for one day or longer.
- Parents who withdraw their consent.
Who the study is looking for
- 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
Age in the registry: 1 hour to 15 days · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Unit of Medical Research in Nutrition Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.