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Clinical Trials in France / NCT06915467
Starting soon Phase 2

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

NCT06915467 · tracked via the Priya Life Science France tracker
Sponsor
Hôpital NOVO
Phase
Phase 2
Started
2025-09
Last updated
2025-09-09

Condition(s) studied

Newborn Morbidity

Investigational drug(s) / intervention(s)

Umbilical vein catheterization through Wharton's jelly procedure

Umbilical vein catheterization through Wharton's jelly procedure: All patients included will receive the Umbilical vein catheterization through Wharton's jelly procedure as first-line treatment: placement of the umbilical line through Wharton's jelly, with simultaneous and systematic preparation of umbilical venous catheter (UVC)

Study summary

The aim of this study is to demonstrate, with a good level of evidence, the efficacy, safety and feasibility of placing an umbilical route through Wharton's jelly, in the context of emergency situations in the delivery room.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Estimation of the success rate of cardiorespiratory resuscitation in less than 90s with the Umbilical vein catheterization through Wharton's jelly as 1st line, in neonates in circulatory arrest in the delivery room — At the beginning of the study, an average of 90 seconds
    Successful completion of the Umbilical vein catheterization through Wharton's jelly procedure is defined as achieving a heart rate (HR) greater than 100 bpm within 90 seconds of the start of the procedure, which corresponds to cord asepsis. The reference procedure (UVC), which has been prepared in parallel, is used as soon as it is ready, if the heart rate is not greater than 100 bpm. The Umbilical vein catheterization through Wharton's jelly procedure is then considered to have failed (because the line has not been inserted, the catheter injection has not been performed or the target rate has not been reached within the time limit)

Trial sites (5)

FacilityCityRegionStatus
Paediatric resuscitation and neonatal medicine department- Centre Hospitalier Universitaire Amiens-Picardie Amiens France
Neonatal medicine department - Hôpital Louis Mourier Colombes France
Neonatal medicine and resuscitation department - Centre hospitalier intercommunal de Poissy Saint-Germain-en-Laye - Poissy site Poissy France
Neonatal medicine - neonatal resuscitation department - Hôpital Delafontaine Saint-Denis France
Neonatal medicine and resuscitation department - Centre Hospitalier de Troyes Troyes France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06915467 on ClinicalTrials.gov ↗ ← All trials in France