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

ClinicalTrials.gov ID

NCT06915467

Lead Sponsor

Hôpital NOVOOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

26Estimated

Last Update Posted

Sep 9, 2025Actual

Start Date

Sep 2025Estimated

Primary Completion Date

Oct 2027Estimated

Completion Date

Oct 2027Estimated

Official Title

Efficacy of Direct CAtheterisation of the OMbilical Vein in Emergency Through Wharton's Jelly in the Delivery Room: Multicentre Study

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.

• Newborn Morbidity

• Umbilical vein catheterization through Wharton's jelly procedure

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Hôpital NOVOOTHER

luc.desfrere@aphp.fr+33 1 47 60 61 31

• Umbilical Vein Needle Catheterization for Endotracheal Intubation.

  NCT03359993

  CompletedObservationalUpdated Jan 26, 2022
• Difficult Intravenous Access in Pediatric Patients: Paramedical Care Using Ultrasound Guidance

  NCT06465121

  RecruitingInterventionalNot ApplicableUpdated Feb 20, 2026
• Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries

  NCT03657394

  Active, not recruitingInterventionalNot ApplicableUpdated Sep 1, 2026
• Efficacy of Ultrasound-guided Internal Jugular Vein Versus Supraclavicular Subclavian Vein Cannulation in Neonates and Infants Less Than 5 kg.

  NCT05956028

  CompletedInterventionalNot ApplicableUpdated Mar 4, 2025
• Umbilical Vessel Catheterization Under ECG Monitoring and Guidance

  NCT03898596

  RecruitingInterventionalNot ApplicableUpdated May 1, 2025
• Central Venous Catheterization Techniques in Neonates

  NCT02688595

  CompletedInterventionalNot ApplicableUpdated Jan 9, 2018