| NCT ID | NCT04429750 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Rare Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2020-10-08 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2020-10-08 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Laurent Storme, MD,PhD
PRINCIPAL INVESTIGATOR
University Hospital, Lille
Frequently Asked Questions
Who can join the NCT04429750 clinical trial?
This trial is open to participants of all sexes, aged 36 Weeks or older, up to 37 Weeks, studying Rare Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04429750 currently recruiting?
Yes, NCT04429750 is actively recruiting participants. Contact the research team at laurent.storme@chru-lille.fr for enrollment information.
Where is the NCT04429750 trial being conducted?
This trial is being conducted at Amiens, France, Lille, France, Nantes, France.
Who is sponsoring the NCT04429750 clinical trial?
NCT04429750 is sponsored by University Hospital, Lille. The principal investigator is Laurent Storme, MD,PhD at University Hospital, Lille. The trial plans to enroll 180 participants.
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