NCT06408376 Physiological Umbilical Cord Clamping in Patients With Congenital Diaphragmatic Hernia. Clinical Trial
| NCT ID | NCT06408376 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital JP Garrahan |
| Condition | Umbilical Cord Clamping |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2022-06-14 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2022-06-14 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Prenatal diagnosis of congenital diaphragmatic hernia * gestational age \>34 weeks * Informed consent signed by the patient's parents Exclusion Criteria: * 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
Contact & Investigator
Mariela Jozefkowicz
PRINCIPAL INVESTIGATOR
Hospital JP Garrahan
Frequently Asked Questions
Who can join the NCT06408376 clinical trial?
This trial is open to participants of all sexes, studying Umbilical Cord Clamping. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06408376 currently recruiting?
Yes, NCT06408376 is actively recruiting participants. Contact the research team at mjozefkowicz@garrahan.gov.ar for enrollment information.
Where is the NCT06408376 trial being conducted?
This trial is being conducted at Buenos Aires, Argentina.
Who is sponsoring the NCT06408376 clinical trial?
NCT06408376 is sponsored by Hospital JP Garrahan. The principal investigator is Mariela Jozefkowicz at Hospital JP Garrahan. The trial plans to enroll 80 participants.