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

NCT ID: NCT06915467

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2027-10-31

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.

Detailed Description

In France, it is estimated that 2 to 4 births per 1000 are complicated by perinatal anoxia. This infrequent event constitutes a vital emergency because, in addition to death, the consequences, particularly neurological, are serious for the survivors. Mortality is high,and estimated at more than half of children when an Apgar score of zero is observed at 5 and 10 minutes, as shown by data found in the literature. When children are born in circulatory arrest, rapid recovery of a heart rate (HR) of more than 100 beats per minute (bpm) to allow correct circulation is therefore essential.

The recommendations of the European Resuscitation Council, updated in 2021, help to guide the birth room practitioner for optimum effectiveness. If the heart rate remains low, after the ventilation method and interface have been checked and adjusted if necessary, cardiac massage is started, and the next step is the emergency administration of adrenaline via the venous route. The reference route is currently the umbilical venous route via an umbilical venous catheter (UVC). This method is effective, but remains a technical procedure and takes a long time to set up, lasting an average of 3 minutes and up to 6 minutes, including just 1 and a half minutes to prepare the equipment and the venous approach. The intra-tracheal route is not prohibited by the latest recommendations, but it has not been shown to be effective and has not been adopted as a reference emergency route in this indication. The intraosseous route has also been studied and mentioned in the recent recommendations of the Société Française de Néonatalogie, but it remains highly invasive and is not routinely used by neonatal resuscitators or paediatricians in the delivery room. Peripheral venous access is difficult because of hypoperfusion, and is not indicated in these emergency situations either.

In this context, the investigator propose to evaluate a quicker and easier infusion method enabling adrenaline to be administered without delay to neonates in circulatory arrest, when the indication is given, i.e. after a well-conducted initial resuscitation. This method consists of catheterising the umbilical vein directly through Wharton's jelly, and injecting the treatments into it.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Umbilical vein catheterization through Wharton's jelly

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)

Group Type: EXPERIMENTAL

Umbilical vein catheterization through Wharton's jelly procedure

Intervention Type: 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)

Interventions

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)

Intervention Type: PROCEDURE

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.

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital NOVO

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Suzanne BORRHOMEE

Role: PRINCIPAL_INVESTIGATOR

Hôpital NOVO - Pontoise site

Locations

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

Countries

France

Central Contacts

Maryline Delattre

Role: CONTACT

maryline.delattre@ght-novo.fr

+3333130754131

Mathilde Wlodarczyk

Role: CONTACT

mathilde.wlodarczyk@ght-novo.fr

+3333130754040

Facility Contacts

Dr Ghida RAMADAN-GHOSTINE

Role: primary

ghostine.ghida@chu-amiens.fr

+33 3 22 08 76 04

Dr Luc DESFRERE

Role: primary

luc.desfrere@aphp.fr

+33 1 47 60 61 31

Dr Emmanuelle Dr MOTTE-SIGNORET

Role: primary

emmanuelle.mottesignoret@ght-yvelinesnord.fr

33 1 39 27 52 35

Dr Alizée LORI

Role: primary

alizee.lori@ch-stdenis.fr

+33 1 42 35 61 10

Dr Ali BILAL

Role: primary

ali.bilal@hcs-sant-.fr

+33 3 25 49 49 12

Other Identifiers

2024-515249-41-00

Identifier Type: CTIS

Identifier Source: secondary_id

CHRD 2419

Identifier Type: -

Identifier Source: org_study_id