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NCT Number: NCT04373902

Physiological-based Cord Clamping in Congenital Diaphragmatic Hernia

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hernias, Diaphragmatic, Congenital Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hernia Hernia, Diaphragmatic Hernia; Diaphragm Defect, Congenital Hypertension Hypertension, Pulmonary Internal Hernia Lung Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pulmonary Hypertension Respiratory Tract Diseases Vascular Diseases

Age range

35 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Monash University, Melbourne, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Physiological-based cord clamping

Procedure

See 'Arm'

Primary outcomes

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

    Time frame: 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:

    • Right ventricular systolic pressure (RVSP) ≥2/3 systemic systolic pressure*
    • Right ventricle (RV) dilatation/septal displacement or RV dysfunction +/- left ventricle (LV) dysfunction*
    • Pre-post ductal SpO2 difference >10% for at least 15 consecutive minutes
    • 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 outcomes

  1. Neonatal: mortality before discharge from the tertiary care hospital

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

    Number of patients that died before discharge

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

    Time frame: The first 24 hours after delivery

    Number of patients with 3 or more criteria or ECMO

  3. Neonatal: 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

    Number of patients requiring ECMO therapy

  4. Neonatal: 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

    Number of days of duration of supplemental oxygen need

  5. Neonatal: 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

    Number of days of duration of mechanical ventilation

  6. Neonatal: duration 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

    Number of days of admission to the tertiary care hospital

  7. Maternal: number of patients with postpartum haemorrhage

    Time frame: The first 24 hours after delivery

    Postpartum haemorrhage is defined as estimated blood loss >1000 mL

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

Physiological-based Cord Clamping Versus Immediate Cord Clamping for Infants Born With Congenital Diaphragmatic Hernia: a Multicentre, Randomised Controlled Trial

Acronym: PinC

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
May 5, 2020
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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