Clinical trial NCT04373902: Physiological-based Cord Clamping in Congenital Diaphragmatic Hernia
Official title: Physiological-based Cord Clamping Versus Immediate Cord Clamping for Infants Born with Congenital Diaphragmatic Hernia: a Multicentre, Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hernias, Diaphragmatic, Congenital
Hernia; Diaphragm Defect, Congenital
Pulmonary Hypertension
Keywords: Congenital diaphragmatic hernia
Perinatal stabilisation
Resuscitation
Pulmonary hypertension
Birth defect
Physiological-based cord clamping
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 140
Sex: ALL
Minimum age (years): 35
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of participants with pulmonary hypertension diagnosed in the first 24 hours after birth.
timeFrame: First 24 hours after birth
Secondary outcomes:
measure: Neonatal: mortality before discharge from the tertiary care hospital
timeFrame: From birth till discharge from the tertiary care hospital, through study completion an average of one year
measure: Neonatal: presence of 3 or more criteria for pulmonary hypertension or extracorporeal membrane oxygenation within 24 hours after birth
timeFrame: The first 24 hours after delivery
measure: Neonatal: number of patients requiring ECMO therapy
timeFrame: From admission to the ICU until the date of death or the date of discharge home, whichever came first
measure: Neonatal: number of days of duration of supplemental oxygen need
timeFrame: 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
measure: Neonatal: number of days of duration of mechanical ventilation
timeFrame: 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
measure: Neonatal: duration of admission to the tertiary care hospital
timeFrame: From admission to the ICU until the date of discharge to another ward or home, whichever came first
measure: Maternal: number of patients with postpartum haemorrhage
timeFrame: The first 24 hours after delivery
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Monash University
city: Graz
country: Austria
facility: Medical University Graz
city: Leuven
country: Belgium
facility: University Hospitals leuven
city: Bonn
country: Germany
facility: Universitätskrankenhaus Bonn
city: Mannheim
country: Germany
facility: Universitätsklinik Mannheim
city: Rome
country: Italy
facility: Ospedale Pediatrico Bambino Gesu
city: Nijmegen
country: Netherlands
facility: Radboudumc University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus MC University Medical Center - Sophia Children's Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
References:
citation: Horn-Oudshoorn EJJ, Knol R, Vermeulen MJ, Te Pas AB, Hooper SB, Cochius-den Otter SCM, Wijnen RMH, Crossley KJ, Rafat N, Schaible T, de Boode WP, Debeer A, Urlesberger B, Roberts CT, Kipfmueller F, Reiss IKM, DeKoninck PLJ. Physiological-based cord clamping versus immediate cord clamping for infants born with a congenital diaphragmatic hernia (PinC): study protocol for a multicentre, randomised controlled trial. BMJ Open. 2022 Mar 18;12(3):e054808. doi: 10.1136/bmjopen-2021-054808.