Intact Cord Resuscitation in CDH

NCT ID: NCT04429750

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-08
• Study Completion Date: 2025-10-31

Brief Summary

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.

Conditions

Rare Diseases; Congenital Diaphragmatic Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Immediate umbilical cord clamping

Intervention Type: PROCEDURE

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).

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.

Group Type: EXPERIMENTAL

intact cord resuscitation

Intervention Type: PROCEDURE

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 36 Weeks
• Maximum Eligible Age: 37 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent Storme, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Chu Amiens Picardie

Amiens, , France

Site Status: RECRUITING

Hop Jeanne de Flandre Chu Lille

Lille, , France

Site Status: RECRUITING

Chu de Nantes -

Nantes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Laurent Storme, MD,PhD

Role: CONTACT

laurent.storme@chru-lille.fr

03 20 44 61 99 ext. +33

Facility Contacts

Role: primary

0320445962

Other Identifiers

2019-A01030-57

Identifier Type: OTHER

Identifier Source: secondary_id

PHRC-18-0234

Identifier Type: OTHER

Identifier Source: secondary_id

2018_94

Identifier Type: -

Identifier Source: org_study_id