Physiological-based Cord Clamping in Congenital Diaphragmatic Hernia

Physiological-based Cord Clamping Versus Immediate Cord Clamping for Infants Born With Congenital Diaphragmatic Hernia: a Multicentre, Randomised Controlled Trial

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 with this rare birth defect might contribute to the development of pulmonary hypertension after birth - in particular umbilical cord clamping before lung aeration. An ovine model of diaphragmatic hernia demonstrated that cord clamping after lung aeration, called physiological-based cord clamping (PBCC), avoided the initial high pressures in the lung vasculature while maintaining adequate blood flow, thereby avoiding vascular remodelling and aggravation of pulmonary hypertension. The investigators aim to investigate if the implementation of PBCC in the perinatal stabilisation period of infants born with a CDH could reduce the incidence of pulmonary hypertension in the first 24 hours after birth.

The investigators will perform a multicentre, randomised controlled trial in infants with an isolated CDH. Before birth, infants will be randomised to either PBCC or immediate cord clamping, stratified by treatment centre and severity of pulmonary hypoplasia on antenatal ultrasound. For performing PBCC a purpose-designed resuscitation module (the Concord Birth Trolley) will be used.

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)