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Physiological-based cord clamping versus immediate cord clamping for infants born with a congenital diaphragmatic
Emily J J Horn-Oudshoorn1, Ronny Knol1, Marijn J Vermeulen1
1Division of Neonatology, Department of Paediatrics, Erasmus MC University Medical Center, Rotterdam, The Netherlands.
Insights
Physiological-based cord clamping (PBCC) may prevent pulmonary hypertension in infants with congenital diaphragmatic hernia (CDH). This study investigates if PBCC reduces pulmonary hypertension incidence within 24 hours after birth in CDH infants.
Area of Science:
- Neonatal Medicine
- Pediatric Surgery
- Cardiology
Background:
- Pulmonary hypertension significantly impacts survival in infants with congenital diaphragmatic hernia (CDH).
- Current perinatal stabilization practices, including early umbilical cord clamping, may contribute to postnatal pulmonary hypertension in CDH infants.
- An ovine model suggests physiological-based cord clamping (PBCC) after lung aeration mitigates pulmonary hypertension development.
Purpose of the Study:
- To evaluate if implementing PBCC during perinatal stabilization reduces the incidence of pulmonary hypertension in infants with CDH within the first 24 hours after birth.
- To assess the impact of PBCC on neonatal and maternal outcomes.
Main Methods:
- A multicenter, randomized controlled trial involving infants with isolated left-sided CDH (gestational age ≥35.0 weeks).
- Infants randomized to either PBCC or immediate cord clamping, stratified by treatment center and pulmonary hypoplasia severity.
- Primary outcome: pulmonary hypertension diagnosis within 24 hours post-birth (clinical and echocardiographic criteria).
Main Results:
- This section is not yet available as the study is ongoing.
Conclusions:
- This study aims to determine if a novel cord clamping strategy can improve outcomes for infants with CDH by reducing pulmonary hypertension.
- Findings could inform updated clinical guidelines for perinatal care in CDH.
Introduction:
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 these infants 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. We 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.
Methods And Analysis:
We will perform a multicentre, randomised controlled trial in infants with an isolated left-sided CDH, born at ≥35.0 weeks. 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. PBCC will be performed using a purpose-built resuscitation trolley. Cord clamping will be performed when the infant is considered respiratory stable, defined as a heart rate >100 bpm, preductal oxygen saturation >85%, while using a fraction of inspired oxygen of <0.5. The primary outcome is pulmonary hypertension diagnosed in the first 24 hours after birth, based on clinical and echocardiographic parameters. Secondary outcomes include neonatal as well as maternal outcomes.
Ethics And Dissemination:
Central ethical approval was obtained from the Medical Ethical Committee of the Erasmus MC, Rotterdam, The Netherlands (METC 2019-0414). Local ethical approval will be obtained by submitting the protocol to the regulatory bodies and local institutional review boards.
Trial Registration Number:
NCT04373902.
