Status:
UNKNOWN
Intact Cord Resuscitation in CDH
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Rare Diseases
Congenital Diaphragmatic Hernia
Eligibility:
All Genders
36-37 years
Phase:
NA
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, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04429750
Start Date
October 8 2020
End Date
October 1 2025
Last Update
January 26 2023
Active Locations (3)
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1
Chu Amiens Picardie
Amiens, France
2
Hop Jeanne de Flandre Chu Lille
Lille, France, 59037
3
Chu de Nantes -
Nantes, France