Cord clamping method for infants with congenital diaphragmatic hernia
Physiological-based Cord Clamping Versus Immediate Cord Clamping for Infants Born with Congenital Diaphragmatic Hernia: a Multicentre, Randomised Controlled Trial
This study is testing if delaying the clamping of the umbilical cord for babies with congenital diaphragmatic hernia can help reduce lung problems in the first day after birth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 35 Weeks and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 9 sites (Melbourne and 8 other locations) |
| Trial ID | NCT04373902 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of physiological-based cord clamping (PBCC) on infants diagnosed with congenital diaphragmatic hernia (CDH). The study aims to determine if delaying cord clamping until after lung aeration can reduce the incidence of pulmonary hypertension in these infants during the critical first 24 hours after birth. By utilizing a multicenter, randomized controlled trial design, the researchers will compare outcomes between standard cord clamping and PBCC. The trial focuses on infants with isolated left-sided CDH, ensuring a controlled environment for evaluating the intervention's efficacy.
Who should consider this trial
Good fit: Ideal candidates for this study are infants with isolated left-sided congenital diaphragmatic hernia born at or after 35 weeks of gestation.
Not a fit: Patients with right-sided or bilateral congenital diaphragmatic hernia, or those born before 35 weeks of gestation, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and reduce complications related to pulmonary hypertension in infants with congenital diaphragmatic hernia.
How similar studies have performed: While the approach of physiological-based cord clamping has shown promise in animal models, its application in human infants with congenital diaphragmatic hernia is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Left-sided CDH * Isolated CDH: no associated structural or genetic abnormalities that are diagnosed before birth * Gestational age at delivery ≥35.0 weeks * Parental written informed consent Exclusion Criteria: * Right-sided or bilateral CDH * Gestational age at delivery \<35.0 weeks * Maternal contraindications: anterior placenta praevia, placental abruption * High urgency caesarean section, with intended interval to delivery \<15 min * Cases that have been treated during pregnancy with experimental drug therapy aiming to decrease the occurrence of pulmonary hypertension * Twin pregnancies in which the infant diagnosed with a CDH is born first * Multiple birth \>2 (triplets or higher order)
Where this trial is running
Melbourne and 8 other locations
- Monash University — Melbourne, Australia (Recruiting)
- Medical University Graz — Graz, Austria (Recruiting)
- University Hospitals leuven — Leuven, Belgium (Recruiting)
- Universitätskrankenhaus Bonn — Bonn, Germany (Recruiting)
- Universitätsklinik Mannheim — Mannheim, Germany (Recruiting)
- Ospedale Pediatrico Bambino Gesu — Rome, Italy (Recruiting)
- Radboudumc University Medical Center — Nijmegen, Netherlands (Recruiting)
- Erasmus MC University Medical Center - Sophia Children's Hospital — Rotterdam, Netherlands (Recruiting)
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
Study contacts
- Study coordinator: Philip LJ DeKoninck, Dr.
- Email: p.dekoninck@erasmusmc.nl
- Phone: 0031107036614
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.