Investigating cord resuscitation techniques for newborns with congenital diaphragmatic hernia
Efficacy of Intact Cord Resuscitation Compared to Immediate Cord Clamping on Cardiorespiratory Adaptation at Birth in Infants With Isolated Congenital Diaphragmatic Hernia (CDH)
NA · University Hospital, Lille · NCT04429750
This study is testing if delaying the clamping of the umbilical cord can help full-term newborns with congenital diaphragmatic hernia breathe better and have better health outcomes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 36 Weeks to 37 Weeks |
| Sex | All |
| Sponsor | University Hospital, Lille (other) |
| Locations | 3 sites (Amiens and 2 other locations) |
| Trial ID | NCT04429750 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are full-term newborns diagnosed with isolated congenital diaphragmatic hernia.
Not a fit: Patients who are preterm or have severe additional malformations or chromosomal diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates and better health outcomes for newborns with congenital diaphragmatic hernia.
How similar studies have performed: Previous studies have indicated potential benefits of delayed cord clamping for newborns, suggesting that this approach may be promising for similar conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amiens and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rare Diseases, Congenital Diaphragmatic Hernia, Congenital diaphragmatic hernia, resuscitation, delayed cord clamping, newborn