Physiological Umbilical Cord Clamping in Patients With Congenital Diaphragmatic Hernia. Clinical Trial

Recruiting now · Not applicable

Conditions studied: Umbilical Cord Clamping, Congenital Diaphragmatic Hernia, Delayed Umbilical Cord Separation

In brief

Congenital diaphragmatic hernia (CDH) is a malformation that affects 1 in every 3000 newborns. The diaphragm does not complete its closure during embryogenesis, which allows the abdominal organs to herniate into the thoracic cavity altering lung development. The lungs of patients with CDH are small, with a decreased surface area for gas exchange and developmental impair of the pulmonary vasculature, resulting in respiratory failure and pulmonary hypertension shortly after birth. When clamping the umbilical cord, a large part of the preload is abruptly excluded, generating an increase in vascular resistance, which in turn increase the afterload, resulting in a decrease in cardiac output. The output is restored by decreasing vascular resistance in pulmonary circuit after lung aeration upon receiving the preload of the right atrium, increasing pulmonary flow and thus sustaining the preload of the left ventricle. If pulmonary aeration occurs before clamping the umbilical cord, the pulmonary blood flow increases before placenta flow is lost, thus avoiding a decrease in cardiac output. This modality has been called physiological base cord clamping (PFC). The hypothesis is that PFC once ventilation has been established could prevent hypoxia and improve cardiac output in newborns with CDH and secondarily improve their hemodynamic parameters, stabilizing gas exchange and pulmonary hypertension during the first 24 hours of birth.

Key facts

Study ID

NCT06408376

Run by

Hospital JP Garrahan

People needed

80

Starts

2022-06-14

Expected to finish

2026-12-31

Last updated by the study team

2024-05-10

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Prenatal diagnosis of congenital diaphragmatic hernia
• gestational age >34 weeks
• Informed consent signed by the patient's parents

You may not qualify if…

• Multiple gestation
• Major malformation or fetal genetic anomaly diagnosed in the prenatal stage
• Emergency cesarean section or maternal condition that prevents the approach
• Lack of informed consent

Where it is running

• Hospital de Pediatría S.A.M.I.C. "Prof. Dr. Juan P. Garrahan" — Buenos Aires, Argentina (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.