Status:
ENROLLING_BY_INVITATION
Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH
Lead Sponsor:
Coordinación de Investigación en Salud, Mexico
Collaborating Sponsors:
University of Southampton
Universidad Nacional Autonoma de Mexico
Conditions:
Pulmonary Hypertension of Newborn
Diaphragm Defect
Eligibility:
All Genders
1-15 years
Phase:
PHASE2
Brief 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 a...
Detailed Description
Background. Persistent pulmonary hypertension of the newborn (PPHN), is a syndrome characterized by difficulty to provide normal pulmonary vasodilatation at birth or after birth, which may be related ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04031508
Start Date
August 12 2019
End Date
December 1 2026
Last Update
August 21 2024
Active Locations (1)
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1
Unit of Medical Research in Nutrition
Mexico City, Mexico City, Mexico, 06720