Physiological-based Cord Clamping in Congenital Diaphragmatic Hernia (PinC)
Hernias, Diaphragmatic, Congenital, Hernia; Diaphragm Defect, Congenital, Pulmonary Hypertension
About this trial
This is an interventional prevention trial for Hernias, Diaphragmatic, Congenital focused on measuring Congenital diaphragmatic hernia, Perinatal stabilisation, Resuscitation, Pulmonary hypertension, Birth defect, Physiological-based cord clamping
Eligibility 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)
Sites / Locations
- Monash UniversityRecruiting
- Medical University GrazRecruiting
- University Hospitals leuvenRecruiting
- Universitätskrankenhaus Bonn
- Universitätsklinik Mannheim
- Ospedale Pediatrico Bambino Gesu
- Radboudumc University Medical CenterRecruiting
- Erasmus MC University Medical Center - Sophia Children's HospitalRecruiting
- Karolinska University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Physiological-based cord clamping
Immediate cord clamping
In PBCC, the Concord will be placed next to the bed of the mother and all equipment will be checked before the second stage of labour has started. The infant will be placed on the platform of the Concord immediately after birth, avoiding any traction or pressure on the cord and avoiding heat loss by radiation heating. The umbilical cord will not be clamped until the infant is considered respiratory stable, which is defined as the presence of a heart rate >100 bpm and preductal oxygen saturation >85%, while using an fraction of inspired oxygen (FiO2) of <0.5. The minimum and maximum times of cord clamping are three and ten minutes after birth, respectively. Oxytocin administration will be postponed until after cord clamping if there are no obstetric concerns. At any time, the attending neonatologist and obstetrician can decide that PBCC should not be performed or be interrupted. In that case, the infant can be placed on the standard resuscitation table for (further) stabilisation.
In the immediate cord clamping group, the cord will be clamped immediately after birth. The infant will then be transferred to the standard neonatal resuscitation table. After cord clamping, all infants will be managed according to the standardised neonatal management protocol for infants with a CDH, which is a consensus of current clinical guidelines by the CDH EURO consortium.