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

Hôpital NOVO

Status and phase: Not yet enrolling; Phase 2

Conditions: Newborn Morbidity

Treatments: Procedure: Umbilical vein catheterization through Wharton's jelly procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT06915467

CHRD 2419

2024-515249-41-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Umbilical vein catheterization through Wharton's jelly

Experimental group

Description:

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)

Treatment:

Procedure: Umbilical vein catheterization through Wharton's jelly procedure