Umbilical vein catheterization through Wharton’s jelly in the delivery room : CaDOm multicenter clinical trial.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Hopital NOVO
- 入组人数
- 26
- 试验地点
- 7
- 主要终点
- 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
研究概览
简要总结
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
入排标准
- 年龄范围
- 0 years 至 17 years(0-17 Years)
- 接受健康志愿者
- 是
入选标准
- •Full-term newborn (≥ 37 weeks of Amenorrhea)
- •Newborn for whom a decision to resuscitate has been made
- •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
- •Newborn beneficiary of a social security system or entitled to
排除标准
- •Newborn with known heart malformation, or another potentially lethal malformation
- •Presence of an approach already laid
- •Pediatric resuscitator not trained in the VOW method
- •Twins born with circulatory arrest requiring simultaneous care
结局指标
主要结局
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
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
次要结局
- 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.
- 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)
- 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)
- Frequency of VOW procedure failures: number of failures over the number of attempts
- 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...
- 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)
- Description of adverse events in the 72 hours following the injection, overall and according to the approach actually used (VOW vs KTVO)
- 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)
- 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
研究者
Suzanne BORRHOMEE
Scientific
Hopital NOVO
