Umbilical vein catheterization through Wharton’s jelly in the delivery room : CaDOm multicenter clinical trial.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hopital NOVO

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Trial duration

1 Oct 2025 → ongoing

Decision date (initial)

2024-12-30

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

PHRC- I 2021 (DGOS, Ministry of Health)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

Estimate the success rate of cardiopulmonary resuscitation in less than 90 seconds with the VOW procedure as first intention, in newborns with circulatory arrest in the delivery room for whom an adrenaline injection is indicated

Secondary objectives 9

1. Measure the duration of installation of the umbilical route through Wharton's jelly (VOW): time between the start of the VOW procedure (cord asepsis), and the start of the adrenaline injection, to compare to duration via KTVO if applicable
2. Measure the time between the start of the VOW procedure and obtaining a heart rate (HR) greater than 100 bpm, to compare to the time during an injection by KTVO if applicable
3. Measure the time between the adrenaline injection and the resumption of a heart rate above 100 bpm, to compare according to the approach used (VOW vs KTVO)
4. Measure the frequency of VOW procedure failures
5. Describe the types of procedural failures and their causes requiring recourse to another approach
6. Measure immediate mortality (at H1) and upon discharge from hospitalization or at 28 days, overall and according to the approach actually used (VOW vs KTVO).
7. Measure tolerance and safety: adverse events within 72 hours, overall and according to the approach used (VOW vs KTVO)
8. Study the relationship between injection time with the VOW procedure and practitioner experience, or cord condition
9. Describe the difficulties encountered when using the VOW procedure

Conditions and MedDRA coding

Cardiorespiratory arrest at birth in full-term newborns

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Full-term newborn (≥ 37 weeks of Amenorrhea)
2. Newborn for whom a decision to resuscitate has been made
3. Newborn in circulatory arrest, or in deep bradycardia < 60 bpm, requiring an injection of adrenaline in the delivery room, the indication being made according to the recommendations of the ERC (European Ressuscitation Council) 2021, after completion of the first cardiopulmonary resuscitation steps, including establishment of effective ventilation
4. Newborn beneficiary of a social security system or entitled to
5. Parents or holders of parental authority aged 18 and over

Exclusion criteria 5

1. Newborn with known heart malformation, or another potentially lethal malformation
2. Presence of an approach already laid
3. Pediatric resuscitator not trained in the VOW method
4. Twins born with circulatory arrest requiring simultaneous care
5. Parents or holders of parental authority with cognitive impairments that prevent them from understanding the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Estimate the success rate of cardiopulmonary resuscitation in less than 90 seconds with the VOW procedure as first intention, in newborns with circulatory arrest in the delivery room for whom an adrenaline injection is indicated

Secondary endpoints 9

1. Duration of placement of the umbilical route through Wharton's jelly (VOW) (delay in seconds between the start of asepsis and the start of the adrenaline injection). To be compared to the KTVO application time (delay between the adrenaline decision and the injection, in order to take into account the KTVO application time) if applicable.
2. Delay in seconds between the start of the VOW procedure and obtaining a heart rate greater than 100 bpm, overall and depending on the approach actually used (compare the delays with VOW procedure versus KTVO procedure if applicable)
3. Delay in seconds between the adrenaline injection and obtaining a heart rate > 100 bpm, overall and depending on the approach actually used (compare the delays with the VOW procedure versus the KTVO procedure if applicable)
4. Frequency of VOW procedure failures: number of failures over the number of attempts
5. Description of types and causes of failures The types of failures are: time exceeded, ineffective injection or an adverse event. The causes of failures could be: a small bowel cord, coloring/opacity of the cord (icteric or impregnated with meconium), extravasation, failure to locate the vein, absence of reflux, maternal hemorrhage, a hardware-related defect (unsuitable needle, unsuitable syringes), secondary perforation of the vein, inability to hold the needle in the vein, move...
6. Mortality rate at H1 and at hospital discharge (or at 28 days), overall and according to the approach actually used (number of patients who died out of the number of patients included)
7. Description of adverse events in the 72 hours following the injection, overall and according to the approach actually used (VOW vs KTVO)
8. Modeling (GLM model) of the relationship between, on the one hand, the success or duration of placement and, on the other hand, the state of the cord (normal or abnormal: if abnormal, it can be thin, meconium-opaque or yellow in the context of jaundice) or the experience of the practitioner (number of years of professional experience in neonatal resuscitation and experience of the VOW procedure)
9. Difficulties when implementing this VOW procedure will be collected from healthcare professionals and described. These difficulties could be as follows: a lack of confidence of the caregiver at the time of the procedure, a lack of personnel, a difficulty in visualizing the vein, a defect linked to the equipment, an abnormal cord,... A likert questionnaire will also be asked of caregivers so that they can indicate their feelings about the complexity of the VOW procedure

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hopital NOVO

Sponsor organisation

Hopital NOVO

Address

6 Avenue De L Ile De France

City

Pontoise

Postcode

95300

Country

France

Scientific contact point

Organisation

Hopital NOVO

Contact name

Suzanne BORRHOMEE

Public contact point

Organisation

Hopital NOVO

Contact name

Maryline DELATTRE

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications