Intact Cord Resuscitation in CDH (CHIC)

University Hospital, Lille

Status: Enrolling

Conditions: Rare Diseases; Congenital Diaphragmatic Hernia

Treatments: Procedure: Immediate umbilical cord clamping; Procedure: intact cord resuscitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04429750

2018_94

PHRC-18-0234 (Other Identifier)

2019-A01030-57 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 36 to 37 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Immediate umbilical cord clamping

Active Comparator group

Description:

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.

Treatment:

Procedure: Immediate umbilical cord clamping

Intact cord resuscitation

Experimental group

Description:

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.

Treatment:

Procedure: intact cord resuscitation