Status:
ACTIVE_NOT_RECRUITING
Physiological-based Cord Clamping in Congenital Diaphragmatic Hernia
Lead Sponsor:
Erasmus Medical Center
Conditions:
Hernias, Diaphragmatic, Congenital
Hernia; Diaphragm Defect, Congenital
Eligibility:
All Genders
35+ years
Phase:
NA
Brief Summary
Pulmonary hypertension is a major determinant of postnatal survival in infants with a congenital diaphragmatic hernia (CDH). The current care during the perinatal stabilisation period in infants born ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04373902
Start Date
May 11 2020
End Date
July 1 2026
Last Update
September 15 2025
Active Locations (9)
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1
Monash University
Melbourne, Australia
2
Medical University Graz
Graz, Austria
3
University Hospitals leuven
Leuven, Belgium
4
Universitätskrankenhaus Bonn
Bonn, Germany