Intact Cord Resuscitation in CDH

NARecruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

October 8, 2020

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2025

Conditions
Rare DiseasesCongenital Diaphragmatic Hernia
Interventions
PROCEDURE

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 between 80 and 95%), the infant will be transferred to the neonatal intensive care unit (NICU). Oxytocin is infused to the mother as recommended in the local protocol (usually just after birth or cord clamping)."

PROCEDURE

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 height can be adjusted in order to position the infant close to the maternal perineum. The infant will be intubated and mechanically ventilated on this trolley. The cord will be clamped once cardiorespiratory stabilization will be obtained (i.e. heart rate\>120/min, increasing preductal O2 saturation or achieving acceptable preductal SpO2 targets between 80 and 95%) or in case of spontaneous placental expulsion. The infant will be then transferred to the neonatal intensive care unit (NICU).

Trial Locations (3)

59037

RECRUITING

Hop Jeanne de Flandre Chu Lille, Lille

Unknown

RECRUITING

Chu Amiens Picardie, Amiens

RECRUITING

Chu de Nantes -, Nantes

All Listed Sponsors
collaborator

Ministry of Health, France

OTHER_GOV

lead

University Hospital, Lille

OTHER