Efficacy of Direct CAtheterisation of the OMbilical Vein in Emergency Through Wharton's Jelly
ConditionNewborn Morbidity
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorHôpital NOVO
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Umbilical vein catheterization through Wharton's jelly procedure
Procedure/SurgeryAll 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)
Treatment groups
26 Participants
are divided into 1 treatment groupGroup A: Umbilical vein catheterization through Wharton's jellyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
At the beginning of the study, an average of 90 secondsSecondary outcomes
1
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)
Time frame
At the beginning of the study, an average of 90 seconds2
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)
Time frame
At the beginning of the study, an average of 90 seconds3
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)
Time frame
At the beginning of the study, an average of 90 seconds4
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
Time frame
At the beginning of the study, an average of 90 secondsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: