Intact Cord Resuscitation in CDH

Официальное название

Efficacy of Intact Cord Resuscitation Compared to Immediate Cord Clamping on Cardiorespiratory Adaptation at Birth in Infants With Isolated Congenital Diaphragmatic Hernia (CDH)

Обзор

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.

Вмешательства

• Процедура Immediate umbilical cord clamping
  In the immediate cord clamping group, the umbilical cord will be clamped within the first 20 seconds after birth and the infant will be transferred to the resuscitation room. The newborn infant will be intubated and mechanically ventilated as quickly as possible on the resuscitation table as recommended in the French "Programme National de Soins". After cardiorespiratory stabilization (i.e. heart rate\>120/min, increasing preductal O2 saturation or achieving acceptable preductal SpO2 targets be
• Процедура intact cord resuscitation
  The umbilical cord will be kept intact during the initial phase of the resuscitation. The infant will be placed on a specifically designed compact trolley with a warmed platform, suitable for commencing resuscitation between the mother's legs in case of vaginal birth or near the operating table beside the mother in case of cesarean section. This trolley will be fully equipped for resuscitation, including a suction device, gas flowmeter/blender, ventilatory support, and monitoring system. Its hei

Первичные конечные точки

• Number of infants with APGAR score < 4 at 1 min or < 7 at 5 min. [Срок оценки: during the first ten minutes after birth]
• APGAR score [Срок оценки: during the first ten minutes after birth]

Вторичные конечные точки (12)

• Frequency of postpartum hemorrhage (PPH) defined by blood loss ≥ 500 ml [Срок оценки: during the deliverance time]
• Frequency of severe PPH, defined by measured blood loss ≥ 1000 ml [Срок оценки: during the deliverance time]
• Blood loss volume after birth [Срок оценки: at 15 minutes after birth, at 1hours after birth]
• Frequency of infants with the need for chest compressions [Срок оценки: during the deliverance time]
• Frequency of infants with the need for epinephrine administration and/or fluid resuscitation [Срок оценки: during the deliverance time]
• Heart rate [Срок оценки: at 1, 5, and 10 min after birth and at 24 hours, 48 hours, 72 hours, at 7 days and at 28 days]
• plasma lactate concentration [Срок оценки: 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 [Срок оценки: at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days]
• changes of ventilatory parameters [Срок оценки: at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days]
• changes of ventilatory parameters [Срок оценки: at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days]
• Volume of fluid resuscitation [Срок оценки: during the first 24 hours]
• Frequency of infants with the need for vasoactive drugs ; [Срок оценки: during the first 24 hours]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Preterm birth less than 37 weeks gestational age
• Other severe malformation(s) or chromosomal diseases
• Twin
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 3 центра

• Chu Amiens Picardie — Amiens
• Hop Jeanne de Flandre Chu Lille — Lille
• Chu de Nantes - — Nantes

Идентификаторы

NCT: NCT04429750 · 2018_94 · 2019-A01030-57 · PHRC-18-0234

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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