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Physiological-based Cord Clamping in Congenital Diaphragmatic Hernia

NCT04373902 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-09-15

No results posted yet for this study

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

PROCEDURE

Physiological-based cord clamping

See 'Arm'

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-11
Primary Completion
2026-06-01
Completion
2026-07-01

Countries

  • Australia
  • Austria
  • Belgium
  • Germany
  • Italy
  • Netherlands
  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04373902 on ClinicalTrials.gov