Hernia; Diaphragm Defect, Congenital, Hernias, Diaphragmatic, Congenital, Pulmonary Hypertension
Conditions
Keywords
Congenital diaphragmatic hernia, Perinatal stabilisation, Resuscitation, Pulmonary hypertension, Birth defect, Physiological-based cord clamping
Brief 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.
Interventions
PROCEDUREPhysiological-based cord clamping
See 'Arm'
Sponsors
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Weeks to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with pulmonary hypertension diagnosed in the first 24 hours after birth. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal: presence of 3 or more criteria for pulmonary hypertension or extracorporeal membrane oxygenation within 24 hours after birth | The first 24 hours after delivery | Number of patients with 3 or more criteria or ECMO |
| Neonatal: number of patients requiring ECMO therapy | From admission to the ICU until the date of death or the date of discharge home, whichever came first | Number of patients requiring ECMO therapy |
| Neonatal: number of days of duration of supplemental oxygen need | 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 | Number of days of duration of supplemental oxygen need |
| Neonatal: mortality before discharge from the tertiary care hospital | From birth till discharge from the tertiary care hospital, through study completion an average of one year | Number of patients that died before discharge |
| Neonatal: duration of admission to the tertiary care hospital | From admission to the ICU until the date of discharge to another ward or home, whichever came first | Number of days of admission to the tertiary care hospital |
| Maternal: number of patients with postpartum haemorrhage | The first 24 hours after delivery | Postpartum haemorrhage is defined as estimated blood loss \>1000 mL |
| Neonatal: number of days of duration of mechanical ventilation | 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 | Number of days of duration of mechanical ventilation |
Countries
Australia, Austria, Belgium, Germany, Italy, Netherlands, Sweden
Outcome results
None listed