Newborn MorbidityPhase 2CaDOmNCT06915467
Efficacy of Direct CAtheterisation of the OMbilical Vein in Emergency Through Wharton's Jelly
A Phase 2 study testing Umbilical vein catheterization through Wharton's jelly procedure in people with Newborn Morbidity, run by Hôpital NOVO at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Newborn Morbidity
- What is being tested?
- Umbilical vein catheterization through Wharton's jelly procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 5 sitesFrance
- Study dates
- Sep 2025to Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Presence of a pre-existing access route
- Paediatric resuscitator not trained to the UVW procedure
- Twins born in circulatory arrest and requiring simultaneous management
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites
Paediatric resuscitation and neonatal medicine department- Centre Hospitalier Universitaire Amiens-Picardie
Amiens, 80054
Dr Ghida RAMADAN-GHOSTINE, +33 3 22 08 76 04, ghostine.ghida@chu-amiens.fr
Neonatal medicine department - Hôpital Louis Mourier
Colombes, 92700
Dr Luc DESFRERE, +33 1 47 60 61 31, luc.desfrere@aphp.fr
Neonatal medicine and resuscitation department - Centre hospitalier intercommunal de Poissy Saint-Germain-en-Laye - Poissy site
Poissy, 78300
Dr Emmanuelle Dr MOTTE-SIGNORET, 33 1 39 27 52 35, emmanuelle.mottesignoret@ght-yvelinesnord.fr
Neonatal medicine - neonatal resuscitation department - Hôpital Delafontaine
Saint-Denis, 93200
Dr Alizée LORI, +33 1 42 35 61 10, alizee.lori@ch-stdenis.fr
Neonatal medicine and resuscitation department - Centre Hospitalier de Troyes
Troyes, 10000
Dr Ali BILAL, +33 3 25 49 49 12, ali.bilal@hcs-sant-.fr
About this study
Official title: Efficacy of Direct CAtheterisation of the OMbilical Vein in Emergency Through Wharton's Jelly in the Delivery Room: Multicentre Study
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.
Read the 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.
- Conditions
- Newborn Morbidity
- Being tested
- Umbilical vein catheterization through Wharton's jelly procedure
- Keywords
- Cardiorespiratory arrest, Newborns, Umbilical Venous Catheter, Wharton's jelly, Neonatal resuscitation, Adrenaline injection
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical vein catheterization through Wharton's jelly procedureProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| Umbilical vein catheterization through Wharton's jelly | Experimental | 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) Receives: Procedure: Umbilical vein catheterization through Wharton's jelly procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Successful completion of the Umbilical vein catheterization through Wharton's jelly procedure is defined as achieving a heart rate (HR) greater than 100 bpm within 90 seconds of the start of the procedure, which corresponds to cord asepsis.
The reference procedure (UVC), which has been prepared in parallel, is used as soon as it is ready, if the heart rate is not greater than 100 bpm. The Umbilical vein catheterization through Wharton's jelly procedure is then considered to have failed (because the line has not been inserted, the catheter injection has not been performed or the target rate has not been reached within the time limit)
Measured: At the beginning of the study, an average of 90 seconds
Secondary outcomes (9)
Measurement of the time taken to insert the umbilical line through Wharton's jelly
The time taken to insert the umbilical line through Wharton's jelly is the time in seconds between the start of asepsis and the start of catheter injection of adrenaline. To be compared with the time taken to insert the UVC (time between the decision to inject adrenaline and the catheter injection, in order to take into account the time taken to insert the UVC)
Measured: 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
Delay in seconds between the start of the Umbilical vein catheterization through Wharton's jelly procedure and obtaining a heart rate above 100 bpm, overall and according to the approach actually used (comparison between delay with Umbilical vein catheterization through Wharton's jelly procedure versus UVC procedure where applicable)
Measured: 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
Delay in seconds between catheter injection of adrenaline and obtaining a heart rate above 100 bpm, overall and according to the approach actually used (comparison between delay with Umbilical vein catheterization through Wharton's jelly procedure versus UVC procedure if applicable)
Measured: 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
The frequency of failure of the Umbilical vein catheterization through Wharton's jelly procedure is the number of failures out of the number of attempts
Measured: 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
The types of failure are: missed deadline, ineffective catheter injection or adverse event.
Causes of failure may include : a small cord, discoloration/opacity of the cord (icteric or impregnated with meconium), extravasation, failure to locate the vein, absence of reflux, maternal haemorrhage, an equipment-related fault (unsuitable needle, unsuitable syringes), secondary perforation of the vein, inability to keep the needle in the vein during catheter injection, movement of the needle during syringe change for rinsing, or a blood exposure accident (BEA) suffered by the carer
Measured: 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)
The mortality rate at H1 and at discharge from hospital (or at 28 days), overall and according to the approach actually used, is the number of patients who died out of the number of patients included
Measured: 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)
Description of adverse events in the 72 hours following catheter injection, overall and according to the approach actually used (Umbilical vein catheterization through Wharton's jelly procedure vs UVC)
Measured: 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
Modelling (General Linear Model) of the relationship between, on the one hand, the success or duration of insertion and, on the other hand, the state of the cord (normal or abnormal: if abnormal, it may be thin, meconium-opaque or yellow in the case of jaundice) or the practitioner's experience (number of years ofl experience in neonatal resuscitation and experience of the Umbilical vein catheterization through Wharton's jelly procedure)
Measured: 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
Difficulties encountered during the implementation of this Umbilical vein catheterization through Wharton's jelly procedure will be collected from healthcare professionals and described. These difficulties could be as follows: a lack of confidence on the part of the carer at the time of the procedure, a shortage of staff, difficulty in visualising the vein, an equipment fault (unsuitable needle, unsuitable syringes), an abnormal cord (small, meconium or yellow indicating jaundice), difficulties in keeping the needle in the vein during catheter injection, movement of the needle during the syringe change for rinsing, ...
Caregivers will also be asked to complete a Likert-type question to assess their feelings about the complexity of the Umbilical vein catheterization through Wharton's jelly procedure. They answer by ticking the box Very easy, Easy, Neither easy nor difficult, Difficult or Very difficult
Measured: At the beginning of the study, an average of 90 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study startSep 2025 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn MorbidityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Suzanne BORRHOMEE, Principal investigator, Hôpital NOVO - Pontoise site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915467
- Sponsor's protocol ID
- CHRD 2419
- Other IDs
- 2024-515249-41-00
- Acronym
- CaDOm
- Status last verified
- Sep 2025
- First submitted
- 31 Mar 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Direct CAtheterisation of the OMbilical Vein in Emergency Through Wharton's Jelly in the Delivery Room: Multicentre Study
- ClinicalTrials.gov ID
- NCT06915467
- Acronym / sponsor ID
- CaDOm / CHRD 2419
- Conditions
- Newborn Morbidity
- Keywords
- Cardiorespiratory arrest, Newborns, Umbilical Venous Catheter, Wharton's jelly, Neonatal resuscitation, Adrenaline injection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Umbilical vein catheterization through Wharton's jelly | Experimental | Procedure: Umbilical vein catheterization through Wharton's jelly procedureAll 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Newborn with known heart defects or other potentially lethal defects
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Umbilical vein catheterization through Wharton's jelly procedureAll 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) | Procedure or surgery | Umbilical vein catheterization through Wharton's jelly |
Primary outcome
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
Successful completion of the Umbilical vein catheterization through Wharton's jelly procedure is defined as achieving a heart rate (HR) greater than 100 bpm within 90 seconds of the start of the procedure, which corresponds to cord asepsis. The reference procedure (UVC), which has been prepared in parallel, is used as soon as it is ready, if the heart rate is not greater than 100 bpm. The Umbilical vein catheterization through Wharton's jelly procedure is then considered to have failed (because the line has not been inserted, the catheter injection has not been performed or the target rate has not been reached within the time limit)
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Suzanne BORRHOMEE principal investigator
Hôpital NOVO - Pontoise site
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Umbilical vein catheterization through Wharton's jelly procedure in people with Newborn Morbidity, run by Hôpital NOVO at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maryline Delattre (+3333130754131, maryline.delattre@ght-novo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: At the beginning of the study, an average of 90 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.