EPINEPHRINE for Cardiorespiratory arrest at birth

Inclusion criteria

• {"criterion_text":"- Full-term newborn (≥ 37 weeks of Amenorrhea)\n- Newborn for whom a decision to resuscitate has been made\n- 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\n- Newborn beneficiary of a social security system or entitled to"}

Exclusion criteria

• {"criterion_text":"- Newborn with known heart malformation, or another potentially lethal malformation\n- Presence of an approach already laid\n- Pediatric resuscitator not trained in the VOW method\n- Twins born with circulatory arrest requiring simultaneous care"}

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Success rate of cardiopulmonary resuscitation in less than 90 seconds with the VOW procedure as first intention (measured as whether cardiopulmonary resuscitation is successful within 90 seconds after procedure start)"}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measured as delay in seconds between start of asepsis and start of adrenaline injection; compared to KTVO application time (delay between adrenaline decision and injection) if applicable."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Measured as seconds from start of VOW procedure to achievement of heart rate >100 bpm; comparisons by approach (VOW vs KTVO) if applicable."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Measured as seconds from adrenaline injection to heart rate >100 bpm; analyzed overall and by approach (VOW vs KTVO)."}
• {"endpoint_text":"- Frequency of VOW procedure failures: number of failures over the number of attempts","definition_or_measurement_approach":"Measured as count: number of VOW procedure failures divided by number of attempts."}
• {"endpoint_text":"- 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...","definition_or_measurement_approach":"Descriptive classification of failure types and causes as listed; collected and reported qualitatively/quantitatively."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Measured as number of deaths at H1 and at hospital discharge or 28 days divided by number included; reported overall and by approach used."}
• {"endpoint_text":"- Description of adverse events in the 72 hours following the injection, overall and according to the approach actually used (VOW vs KTVO)","definition_or_measurement_approach":"Adverse events collected within 72 hours post-injection and described overall and by approach (VOW vs KTVO)."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Analytical modelling (GLM) to assess association between success/duration and cord state or practitioner experience (years and VOW experience)."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Qualitative collection from healthcare professionals and Likert questionnaire assessing perceived complexity; descriptive reporting of listed difficulty types."}

France

Earliest CTIS Part Ii Submission Date

18-12-2024

Latest Decision Or Authorization Date

11-06-2025

Processing Time Days

175

Number Of Sites

8

Number Of Participants

26

Primary sponsor

Full Name

Hopital NOVO

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France