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

NCT06915467 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: CHRD 24192024-515249-41-00
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Newborn Morbidity

Keywords

Cardiorespiratory arrest; Newborns; Umbilical Venous Catheter; Wharton's jelly; Neonatal resuscitation; Adrenaline injection

Outcome Measures

Primary Outcomes (1)

• 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

  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)

  At the beginning of the study, an average of 90 seconds

Secondary Outcomes (9)

• Measurement of the time taken to insert the umbilical line through Wharton's jelly

  At the beginning of the study, an average of 90 seconds

• Measurement of the delay between the start of the Umbilical vein catheterization through Wharton's jelly procedure and the achievement of a heart rate greater than 100 bpm, to be compared with the delay for an injection via UVC if applicable

  At the beginning of the study, an average of 90 seconds

• Measurement of the delay between the injection of adrenaline by catheter and the resumption of a heart rate greater than 100 bpm, to be compared with the line actually used

  At the beginning of the study, an average of 90 seconds

• Measurement of the frequency of failure of the Umbilical vein catheterization through Wharton's jelly procedure

  At the beginning of the study, an average of 90 seconds

• Description of the types of procedure failure and their causes, requiring the use of another approach

  At the beginning of the study, an average of 90 seconds

Study Arms (1)

Umbilical vein catheterization through Wharton's jelly

EXPERIMENTAL

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

Procedure: Umbilical vein catheterization through Wharton's jelly procedure

Interventions

Umbilical vein catheterization through Wharton's jelly procedure 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)

Umbilical vein catheterization through Wharton's jelly

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

Sponsors & Collaborators

• Hôpital NOVO: lead

Study Sites (5)

Paediatric resuscitation and neonatal medicine department- Centre Hospitalier Universitaire Amiens-Picardie

Amiens, 80054, France

Location

Neonatal medicine department - Hôpital Louis Mourier

Colombes, 92700, France

Location

Neonatal medicine and resuscitation department - Centre hospitalier intercommunal de Poissy Saint-Germain-en-Laye - Poissy site

Poissy, 78300, France

Location

Neonatal medicine - neonatal resuscitation department - Hôpital Delafontaine

Saint-Denis, 93200, France

Location

Neonatal medicine and resuscitation department - Centre Hospitalier de Troyes

Troyes, 10000, France

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Dr Suzanne BORRHOMEE

  Hôpital NOVO - Pontoise site

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maryline Delattre

CONTACT

+3333130754131; maryline.delattre@ght-novo.fr

Mathilde Wlodarczyk

CONTACT

+3333130754040; mathilde.wlodarczyk@ght-novo.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 8, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

FR (5)