Efficacy of Intact Cord Resuscitation Compared to Immediate Cord Clamping on Cardiorespiratory Adaptation at Birth in Infants With Isolated Congenital Diaphragmatic Hernia (CDH)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 4
- 主要终点
- APGAR score
研究概览
简要总结
Isolated CDH is a rare disease (1/3500) and displays a wide range of severity and outcome. Despite attempts to standardize the management of this disease at birth and during the first months of life, the mortality varies from 20 to 50% according to different hospitals in France and abroad.
Several studies already showed the benefice of late cord clamping at birth on biological and physiological adaptation of newborns to life. Previous works also suggest a possible benefit of this procedure for babies with CDH.
This multicenter randomized clinical study aims to investigate the efficacy of intact cord resuscitation compared to immediate cord clamping on cardiorespiratory adaptation at birth in full term newborn infants with isolated CDH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 36 Weeks 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Antenatal diagnosis of CDH
- •No severe additional malformation or chromosomal diseases
- •Full term (>36 weeks gestational age)
- •No inclusion in another antenatal trial
- •Written informed consents from the parents
排除标准
- •Preterm birth less than 37 weeks gestational age
- •Other severe malformation(s) or chromosomal diseases
- •Parents who may have French language understanding difficulties may not participate to the study unless they receive appropriate assistance regarding the understanding of the formal consent forms needed to get included in the study. If included in the study, regarding their French understanding level, the parents may not be proposed the auto questionnaires and interviews led by the psychologist
研究组 & 干预措施
Immediate umbilical cord clamping
This group includes newborn infants with isolated CDH who will benefit from the standardized CDH management procedure as described in the French national CDH management guidelines ("Programme National de Soins").The resuscitation maneuvers are started after the umbilical cord is clamped.
干预措施: Immediate umbilical cord clamping (Procedure)
Intact cord resuscitation
This group includes newborn infants with isolated CDH who will benefit from the standardized CDH resuscitation maneuvers as described in the French national CDH management guidelines ("Programme National de Soins") before the umbilical cord is clamped. The resuscitation maneuvers are started at birth while the umbilical cord still bridges mother and child.
干预措施: intact cord resuscitation (Procedure)
结局指标
主要结局
APGAR score
时间窗: during the first ten minutes after birth
APGAR at 1, 5 and 10 minutes after birth will be reassessed retrospectively by a final observer. The reassessment will be carried out using a video of the first 10 minutes of life of the newborn filmed with a camera if the parents agree. This video will only record the appearance of babies' bodies and faces
Number of infants with APGAR score < 4 at 1 min or < 7 at 5 min.
时间窗: during the first ten minutes after birth
次要结局
- Frequency of infants with the need for chest compressions(during the deliverance time)
- Frequency of severe PPH, defined by measured blood loss ≥ 1000 ml(during the deliverance time)
- Infant mortality rate(at 90-day after birth)
- the Intolerance for Uncertainty Scale (EII).(at the end of the study period (90±7 days after birth).)
- Frequency of infants with the need for epinephrine administration and/or fluid resuscitation(during the deliverance time)
- Heart rate(at 1, 5, and 10 min after birth and at 24 hours, 48 hours, 72 hours, at 7 days and at 28 days)
- Frequency of postpartum hemorrhage (PPH) defined by blood loss ≥ 500 ml(during the deliverance time)
- Blood loss volume after birth(at 15 minutes after birth, at 1hours after birth)
- Number of refusal of participating to the protocol.(at the end of the study period (90±7 days after birth))
- State Trait Anxiety Inventory (STAI) revised version, form Y(within the first 48 hours after birth, and at the end of the study period (90±7 days after birth).)
- Semi-structured interviews(at the end of the study period (12 months after birth))
- plasma lactate concentration(at one hour after birth (H1): at 24 hours, 48 hours, 72 hours, at 7 days and at 28 days)
- changes of global Blood gases parameters(at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days)
- Frequency of infants with the need for pulmonary vasodilator(during the first 24 hours)
- Hemoglobin concentration(at 24 hours)
- Infant morbidity outcomes assessed within the first 90 days after birth(at 90-day after birth)
- the Impact of Event Scale-Revised (IES-R)(during the 7 days prior to completion and at the end of the study period (90±7 days after birth).)
- Echographic parameters with the Resistive index and pulsatility index in the anterior cerebral artery(at H6, H24, H24 after the chirurgical CDH repair gesture, H48, D7, D28)
- Frequency of infants with the need for vasoactive drugs ;(during the first 24 hours)
- changes of ventilatory parameters(at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days)
- Volume of fluid resuscitation(during the first 24 hours)
- the 'faceless' acute neonatal pain scale (FANS)(during intubation)
- Cerebral Near-infrared spectroscopy recorded(at H1, H2, H6, H12, H24, H48)
- A parental questionnaire to assess neurological development (ASQ 3 score).(at M6 and M12)