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Search / Trial NCT06915467

Efficacy of Direct CAtheterisation of the OMbilical Vein in Emergency Through Wharton's Jelly

Launched by HÔPITAL NOVO · Mar 31, 2025

Trial Information

Current as of June 27, 2025

Not yet recruiting

Keywords

Cardiorespiratory Arrest Newborns Umbilical Venous Catheter Wharton's Jelly Neonatal Resuscitation Adrenaline Injection

ClinConnect Summary

This clinical trial is studying a new method for emergencies in newborns, specifically how to place a catheter (a small tube) in the umbilical vein using a special tissue called Wharton's jelly. This procedure aims to provide quick and effective care for newborns who are experiencing severe health issues right after birth, like very slow heart rates or needing emergency medication. The goal is to show that this method is safe and can be done easily in delivery rooms.

To participate in this trial, newborns must be full-term (born at least 37 weeks), and they must be in need of resuscitation due to serious heart conditions. Unfortunately, babies with known heart defects or those who already have a different access route for treatment won't be eligible. If a newborn qualifies, medical staff will follow specific guidelines to provide care, and families can expect thorough monitoring and support throughout the process. This trial is important because it could improve emergency treatment options for newborns in critical situations.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria :
  • Full-term newborn (≥ 37 SA)
  • Newborn for whom a resuscitation decision has been taken.
  • Newborn in circulatory arrest, or in profound bradycardia \< 60 bpm, requiring an injection of adrenaline in the delivery room, the indication being established in accordance with the recommendations of the European Resuscitation Council 2021, after completion of the first stages of cardiopulmonary resuscitation, including the establishment of effective ventilation
  • Newborn beneficiary of a social security scheme or entitled person.
  • Non-inclusion Criteria :
  • Newborn with known heart defects or other potentially lethal defects
  • Presence of a pre-existing access route
  • Paediatric resuscitator not trained to the UVW procedure
  • Twins born in circulatory arrest and requiring simultaneous management

About Hôpital Novo

Hôpital Novo is a leading clinical trial sponsor dedicated to advancing medical research and improving patient outcomes through innovative studies and rigorous scientific methodologies. With a strong emphasis on collaboration and ethical practices, Hôpital Novo partners with healthcare professionals and institutions to conduct high-quality clinical trials across various therapeutic areas. Their commitment to patient safety, data integrity, and regulatory compliance ensures that all research initiatives are conducted to the highest standards, ultimately contributing to the development of new treatments and therapies that enhance healthcare delivery.

Locations

Amiens, , France

Colombes, , France

Poissy, , France

Saint Denis, , France

Troyes, , France

Patients applied

0 patients applied

Trial Officials

Dr Suzanne BORRHOMEE

Principal Investigator

Hôpital NOVO - Pontoise site

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported