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Not yet recruiting NCT06915467

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

Phase II Interventional Newborn Morbidity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Umbilical vein catheterization through Wharton's jelly procedure.
Who it may be relevant to
Registry conditions: Newborn Morbidity. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Procedure 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)

Primary outcome measures

  • 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 [Time frame: At the beginning of the study, an average of 90 seconds]
Secondary outcome measures (9)
  • Measurement of the time taken to insert the umbilical line through Wharton's jelly [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: At the beginning of the study, an average of 90 seconds]
  • 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) [Time frame: At the beginning of the study, an average of 90 seconds]
  • 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) [Time frame: At 72 hours after the beginning of the study]
  • 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 [Time frame: At the beginning of the study, an average of 90 seconds]
  • Description of the difficulties encountered when using the Umbilical vein catheterization through Wharton's jelly procedure [Time frame: At the beginning of the study, an average of 90 seconds]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 5 centers
  • Paediatric resuscitation and neonatal medicine department- Centre Hospitalier Universitair — Amiens
  • Neonatal medicine department - Hôpital Louis Mourier — Colombes
  • Neonatal medicine and resuscitation department - Centre hospitalier intercommunal de Poiss — Poissy
  • Neonatal medicine - neonatal resuscitation department - Hôpital Delafontaine — Saint-Denis
  • Neonatal medicine and resuscitation department - Centre Hospitalier de Troyes — Troyes

Identifiers

NCT: NCT06915467 · CHRD 2419 · 2024-515249-41-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗