Physiological-based Cord Clamping in Congenital Diaphragmatic Hernia

  • STATUS
    Recruiting
  • End date
    Jul 1, 2023
  • participants needed
    140
  • sponsor
    Erasmus Medical Center
Updated on 12 August 2021
hypertension
resuscitation
umbilical cord clamping
diaphragmatic hernia
pulmonary hypoplasia
congenital diaphragmatic hernia

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.

Details
Condition Pulmonary Hypertension, Cancer Prevention, Surviving Abuse, Joint Injuries, Abdominal Surgery, Mental Disability, Pelvic Adhesions, Low Testosterone, Dental Filling, Habit Reversal, Complicated Grief, Chronic Pelvic Pain, Gambling Problems, Myopic Macular Degeneration, Nerve Injury, Severe Premenstrual Symptom, Stasis Dermatitis, Pulmonary Arterial Hypertension, Open Heart Surgery, Recurrent Pregnancy Loss, Effects of Chemotherapy, Renal Anemia, Functional Dyspepsia, Catheter Complications, Serial Evaluation of Ductal Epithelium, Chronic Renal Anemia, Cancer Treatment, Anemic Cancer, Spinocerebellar Disorders, Pseudobulbar Affect, Spine Athroplasty, Indikation: Diabetes - Typ II, Partial Medial Meniscectomy, Primary Insulin Hypersecretion, Testotoxikose, Infantile Fibrosarcoma, Late Infantile Neuronal Ceroid Lipfuscinsosis, Memory Problems, Hernias, Diaphragmatic, Congenital, Hernia; Diaphragm Defect, Congenital, Hernias, Diaphragmatic, Congenital, Hernia; Diaphragm Defect, Congenital, Hernias, Diaphragmatic, Congenital, Hernia; Diaphragm Defect, Congenital, Hernias, Diaphragmatic, Congenital, Hernia; Diaphragm Defect, Congenital, Hernias, Diaphragmatic, Congenital, Hernia; Diaphragm Defect, Congenital, Hernias, Diaphragmatic, Congenital, Hernia; Diaphragm Defect, Congenital, Hernias, Diaphragmatic, Congenital, Hernia; Diaphragm Defect, Congenital, Hernias, Diaphragmatic, Congenital, Hernia; Diaphragm Defect, Congenital, Hernias, Diaphragmatic, Congenital, Hernia; Diaphragm Defect, Congenital, Hernias, Diaphragmatic, Congenital, Hernias, Diaphragmatic, Congenital, Hernia; Diaphragm Defect, Congenital, Hernia; Diaphragm Defect, Congenital, Hernias, Diaphragmatic, Congenital, Hernia; Diaphragm Defect, Congenital
Treatment physiological-based cord clamping
Clinical Study IdentifierNCT04373902
SponsorErasmus Medical Center
Last Modified on12 August 2021

Eligibility

Yes No Not Sure

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)
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