Clinical trial NCT06915467: Efficacy of Direct CAtheterisation of the OMbilical Vein in Emergency Through Wharton's Jelly
Official title: Efficacy of Direct CAtheterisation of the OMbilical Vein in Emergency Through Wharton's Jelly in the Delivery Room: Multicentre Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Newborn Morbidity
Keywords: Cardiorespiratory arrest
Newborns
Umbilical Venous Catheter
Wharton's jelly
Neonatal resuscitation
Adrenaline injection
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 outcomes:
measure: 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
timeFrame: At the beginning of the study, an average of 90 seconds
Secondary outcomes:
measure: Measurement of the time taken to insert the umbilical line through Wharton's jelly
timeFrame: At the beginning of the study, an average of 90 seconds
measure: 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
timeFrame: At the beginning of the study, an average of 90 seconds
measure: 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
timeFrame: At the beginning of the study, an average of 90 seconds
measure: Measurement of the frequency of failure of the Umbilical vein catheterization through Wharton's jelly procedure
timeFrame: At the beginning of the study, an average of 90 seconds
measure: Description of the types of procedure failure and their causes, requiring the use of another approach
timeFrame: At the beginning of the study, an average of 90 seconds
measure: Measurement of immediate mortality (at H1) and mortality at discharge from hospital, or 28 days, overall and according to the approach actually used (Umbilical vein catheterization through Wharton's jelly procedure vs UVC)
timeFrame: At the beginning of the study, an average of 90 seconds
measure: Measurement of tolerance and safety: adverse events within 72 hours, overall and according to the approach used (Umbilical vein catheterization through Wharton's jelly procedure vs UVC)
timeFrame: At 72 hours after the beginning of the study
measure: Study of the relationship between the delay to inject adrenaline by catheter with the Umbilical vein catheterization through Wharton's jelly procedure and the practitioner's experience, or the condition of the cord
timeFrame: At the beginning of the study, an average of 90 seconds
measure: Description of the difficulties encountered when using the Umbilical vein catheterization through Wharton's jelly procedure
timeFrame: At the beginning of the study, an average of 90 seconds
Other outcomes:
Locations:
city: Amiens
country: France
facility: Paediatric resuscitation and neonatal medicine department- Centre Hospitalier Universitaire Amiens-Picardie
city: Colombes
country: France
facility: Neonatal medicine department - Hôpital Louis Mourier
city: Poissy
country: France
facility: Neonatal medicine and resuscitation department - Centre hospitalier intercommunal de Poissy Saint-Germain-en-Laye - Poissy site
city: Saint-Denis
country: France
facility: Neonatal medicine - neonatal resuscitation department - Hôpital Delafontaine
city: Troyes
country: France
facility: Neonatal medicine and resuscitation department - Centre Hospitalier de Troyes
Study officials:
affiliation: Hôpital NOVO - Pontoise site
name: Dr Suzanne BORRHOMEE
role: PRINCIPAL_INVESTIGATOR
References: