Physiological-based Cord Clamping in Congenital Diaphragmatic Hernia

N/AActive Not RecruitingNCT04373902

Erasmus Medical Center140 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

140

Conditions

Hernias, Diaphragmatic, Congenital

Eligibility

Sex: ALLMin age: 35 Weeks

Medical Language ↔ Plain English

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)

Locations (9)

Monash University

Melbourne, Australia

Medical University Graz

Graz, Austria

University Hospitals leuven

Leuven, Belgium

Universitätskrankenhaus Bonn

Bonn, Germany

Universitätsklinik Mannheim

Mannheim, Germany

Ospedale Pediatrico Bambino Gesu

Rome, Italy

Radboudumc University Medical Center

Nijmegen, Netherlands

Erasmus MC University Medical Center - Sophia Children's Hospital

Rotterdam, Netherlands

Karolinska University Hospital

Stockholm, Sweden

Outcomes

Primary Outcomes

Number of participants with pulmonary hypertension diagnosed in the first 24 hours after birth.

Pulmonary hypertension is present if at least 2 of the following 4 criteria are present or if the infant requires extracorporeal membrane oxygenation (ECMO) in the first 24 hours after birth: 1. Right ventricular systolic pressure (RVSP) ≥2/3 systemic systolic pressure\* 2. Right ventricle (RV) dilatation/septal displacement or RV dysfunction +/- left ventricle (LV) dysfunction\* 3. Pre-post ductal SpO2 difference \>10% for at least 15 consecutive minutes 4. Oxygenation Index \>20\*\* \*as found on first ultrasound in first 24 hours after birth; \*\*highest value measured in first 24 hours after birth The following echocardiographic parameters will be collected to objectify these criteria: * RV size * Pulmonary artery acceleration time (PAAT), right ventricular ejection time (RVET), PAAT:RVET ratio * Intraventricular septum configuration * LV systolic eccentricity index * Mean airway pressure * PaO2 * FiO2 * Preductal+postductal SpO2

Time frame: First 24 hours after birth

Secondary Outcomes

Neonatal: mortality before discharge from the tertiary care hospital

Number of patients that died before discharge

Time frame: From birth till discharge from the tertiary care hospital, through study completion an average of one year

Neonatal: presence of 3 or more criteria for pulmonary hypertension or extracorporeal membrane oxygenation within 24 hours after birth

Number of patients with 3 or more criteria or ECMO

Time frame: The first 24 hours after delivery

Neonatal: number of patients requiring ECMO therapy

Number of patients requiring ECMO therapy

Time frame: From admission to the ICU until the date of death or the date of discharge home, whichever came first

Neonatal: number of days of duration of supplemental oxygen need

Number of days of duration of supplemental oxygen need

Time frame: From admission to the ICU until the date of discharge to another ward or home, whichever came first,through study completion an average of one year

Neonatal: number of days of duration of mechanical ventilation

Number of days of duration of mechanical ventilation

Time frame: From admission to the ICU until the date of discharge to another ward or home, whichever came first,through study completion an average of one year

Neonatal: duration of admission to the tertiary care hospital

Number of days of admission to the tertiary care hospital

Time frame: From admission to the ICU until the date of discharge to another ward or home, whichever came first

Maternal: number of patients with postpartum haemorrhage

Postpartum haemorrhage is defined as estimated blood loss \>1000 mL