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Search / Trial NCT04031508

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

Launched by COORDINACIÓN DE INVESTIGACIÓN EN SALUD, MEXICO · Jul 22, 2019

Trial Information

Current as of July 09, 2025

Enrolling by invitation

Keywords

Pphn Diaphragmatic Hernia Omega 3 Dha And Epa

ClinConnect Summary

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 to right ventricular dysfunction, congenital diaphragmatic hernia, sepsis, and meconium aspiration. This condition is understudied. PPHN causes pulmonary vascular resistance (PVR) that decreases left pulmonary artery flow (LPA), meaning that blood cannot be oxygenated in the lungs, leading to low oxygen delivery to all organs. Expensive medication along with ventilator support may help, but the...

Gender

ALL

Eligibility criteria

  • 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.

About Coordinación De Investigación En Salud, Mexico

Coordinación de Investigación en Salud, Mexico, is a leading clinical trial sponsor dedicated to advancing medical research and enhancing public health outcomes. With a robust infrastructure and a commitment to ethical standards, the organization collaborates with a network of healthcare professionals and institutions to conduct innovative clinical studies across various therapeutic areas. By leveraging cutting-edge methodologies and adhering to rigorous regulatory guidelines, Coordinación de Investigación en Salud aims to generate high-quality evidence that informs clinical practices and contributes to the development of safe and effective treatments for diverse populations.

Locations

Mexico, Ciudad De Mexico, Mexico

Patients applied

0 patients applied

Trial Officials

Mariela Bernabe-Garcia, Ph.D.

Principal Investigator

Instituto Mexicano del Seguro Social

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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