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Intact Cord Resuscitation in CDH

RecruitingNAAges 36 Weeks - 37 WeeksAllUniversity Hospital, Lille
NCT04429750 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Immediate umbilical cord clamping
  • intact cord resuscitation
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Where

3 sites
Chu Amiens Picardie
Amiens, France
Hop Jeanne de Flandre Chu Lille
Lille, France
Chu de Nantes -
Nantes, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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