Physiological umbilical cord clamping for newborns with congenital diaphragmatic hernia
Physiological Umbilical Cord Clamping in Patients With Congenital Diaphragmatic Hernia. Clinical Trial
This study tests if a special way of clamping the umbilical cord can help newborns with congenital diaphragmatic hernia breathe better and have healthier hearts compared to the usual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Sex | All |
| Sponsor | Hospital JP Garrahan Government |
| Locations | 1 site (Buenos Aires) |
| Trial ID | NCT06408376 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of physiological umbilical cord clamping in newborns diagnosed with congenital diaphragmatic hernia (CDH). The study aims to compare this method to immediate post-intubation clamping to assess its impact on reducing hypoxia and improving cardiac output. Conducted at Garrahan Children's Hospital, the trial will involve randomized participants who meet specific inclusion criteria, including a prenatal diagnosis of CDH and a gestational age of over 34 weeks. The study will also evaluate patient evolution and maternal outcomes within 24 hours post-birth.
Who should consider this trial
Good fit: Ideal candidates for this study are newborns with a prenatal diagnosis of congenital diaphragmatic hernia and a gestational age greater than 34 weeks.
Not a fit: Patients with multiple gestations, major malformations, or those requiring emergency cesarean sections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve respiratory outcomes and cardiac function in newborns with congenital diaphragmatic hernia.
How similar studies have performed: While the approach of physiological umbilical cord clamping is gaining attention, its specific application in congenital diaphragmatic hernia is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Buenos Aires
- Hospital de Pediatría S.A.M.I.C. "Prof. Dr. Juan P. Garrahan" — Buenos Aires, Argentina (Recruiting)
Study contacts
- Principal investigator: Mariela Jozefkowicz — Hospital JP Garrahan
- Study coordinator: Mariela Jozefkowicz
- Email: mjozefkowicz@garrahan.gov.ar
- Phone: +5491164646270
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.