Physiological-based Cord Clamping in Congenital Diaphragmatic Hernia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-11

Study Completion Date

2026-07-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Hernias, Diaphragmatic, Congenital Hernia; Diaphragm Defect, Congenital Pulmonary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Physiological-based cord clamping

In PBCC, the Concord will be placed next to the bed of the mother and all equipment will be checked before the second stage of labour has started. The infant will be placed on the platform of the Concord immediately after birth, avoiding any traction or pressure on the cord and avoiding heat loss by radiation heating. The umbilical cord will not be clamped until the infant is considered respiratory stable, which is defined as the presence of a heart rate \>100 bpm and preductal oxygen saturation \>85%, while using an fraction of inspired oxygen (FiO2) of \<0.5. The minimum and maximum times of cord clamping are three and ten minutes after birth, respectively. Oxytocin administration will be postponed until after cord clamping if there are no obstetric concerns. At any time, the attending neonatologist and obstetrician can decide that PBCC should not be performed or be interrupted. In that case, the infant can be placed on the standard resuscitation table for (further) stabilisation.

Group Type EXPERIMENTAL

Physiological-based cord clamping

Intervention Type PROCEDURE

See 'Arm'

Immediate cord clamping

In the immediate cord clamping group, the cord will be clamped immediately after birth. The infant will then be transferred to the standard neonatal resuscitation table. After cord clamping, all infants will be managed according to the standardised neonatal management protocol for infants with a CDH, which is a consensus of current clinical guidelines by the CDH EURO consortium.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Physiological-based cord clamping

See 'Arm'

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

35 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No