Physiological umbilical cord clamping for newborns with congenital diaphragmatic hernia
Official title: Physiological Umbilical Cord Clamping in Patients With Congenital Diaphragmatic Hernia. Clinical Trial
Run by Hospital JP Garrahan · NCT06408376 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Hospital JP Garrahan Government |
| Locations | 1 site (Buenos Aires) |
| Status | Recruiting |
| Started | June 14, 2022 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | May 10, 2024 |
| Trial ID | NCT06408376 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with multiple gestations, major malformations, or those requiring emergency cesarean sections may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
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This study tests whether performing Fetoscopic Endoluminal Tracheal Occlusion on pregnancies with fetal diaphragmatic hernia improves baby survival and reduces long-term problems.
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Fetal tracheal occlusion (FETO) for severe congenital diaphragmatic hernia
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Long-term outcomes after FETO for severe left or right congenital diaphragmatic hernia
This trial will test whether performing FETO in fetuses with isolated severe left or right CDH helps more babies survive to hospital discharge and have fewer long-term problems than standard care.
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Fetal treatment for congenital diaphragmatic hernia
This study is testing a new way to treat congenital diaphragmatic hernia in unborn babies by placing a balloon in their airway to help their lungs grow before they are born.
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Fetoscopic balloon (FETO) for severe left and right congenital diaphragmatic hernia — long-term outcomes
This trial will try placing and later removing a tiny balloon in the fetal windpipe around 27–29 weeks to help babies with severe congenital diaphragmatic hernia and liver herniation survive the newborn period.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.