Investigating cord resuscitation techniques for newborns with congenital diaphragmatic hernia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial examines the effects of intact cord resuscitation versus immediate cord clamping on the cardiorespiratory adaptation of full-term newborns diagnosed with isolated congenital diaphragmatic hernia (CDH). Given the high mortality rates associated with CDH, the study aims to determine if delaying cord clamping can improve outcomes for these infants. The trial is multicenter and randomized, involving several hospitals in France to ensure a diverse patient population. Parents must provide informed consent for their participation, and the study excludes preterm infants and those with severe additional malformations.

Why it matters

Who can join: the full rules

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

Where it's running

• Chu Amiens Picardie
  Amiens, France Recruiting
• Hop Jeanne de Flandre Chu Lille
  Lille, France Recruiting
• Chu de Nantes -
  Nantes, France Recruiting

Study contacts

• Principal investigator: Laurent Storme, MD,PhD — University Hospital, Lille
• Study coordinator: Laurent Storme, MD,PhD
• Email: laurent.storme@chru-lille.fr
• Phone: 03 20 44 61 99

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.