NCT04373902

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 35 Weeks
• Healthy volunteers: Not accepted

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 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.

Conditions

• Hernias, Diaphragmatic, Congenital
• Hernia; Diaphragm Defect, Congenital
• Pulmonary Hypertension

Interventions

Type	Name	Description
PROCEDURE	Physiological-based cord clamping	See 'Arm'

Timeline

• Start date: 2020-05-11
• Primary completion: 2026-06-01
• Completion: 2026-07-01
• First posted: 2020-05-05
• Last updated: 2025-09-15

Locations

9 sites across 7 countries: Australia, Austria, Belgium, Germany, Italy, Netherlands, Sweden