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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8 months
Maximum Age: 8 months
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Chu Amiens Picardie
RECRUITING
Amiens
Hop Jeanne de Flandre Chu Lille
RECRUITING
Lille
Chu de Nantes -
RECRUITING
Nantes
Contact Information
Primary
Laurent Storme, MD,PhD
laurent.storme@chru-lille.fr
03 20 44 61 99
Time Frame
Start Date: 2020-10-08
Estimated Completion Date: 2025-10
Participants
Target number of participants: 180
Treatments
Active_comparator: 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.
Experimental: 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.
Sponsors
Collaborators: Ministry of Health, France
Leads: University Hospital, Lille

This content was sourced from clinicaltrials.gov