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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Amiens, , France
Colombes, , France
Poissy, , France
Saint Denis, , France
Troyes, , France
Patients applied
Trial Officials
Dr Suzanne BORRHOMEE
Principal Investigator
Hôpital NOVO - Pontoise site
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported