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NCT03242044
Resuscitation of Infants With Congenital Diaphragmatic Hernia With an Intact Umbilical Cord
NA trial testing Congenital diaphragmatic hernia resuscitation with an intact umbilical cord in Congenital Diaphragmatic Hernia in 10 participants. Completed in 21 October 2020.
21 October 2020
Quick facts
| Lead sponsor | University of Colorado, Denver |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 12 January 2018 |
| Primary completion | 21 October 2020 |
| Estimated completion | 21 October 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Congenital diaphragmatic hernia resuscitation with an intact umbilical cord
Conditions studied
- Congenital Diaphragmatic Hernia — all drugs for Congenital Diaphragmatic Hernia →
Sponsor
University of Colorado, Denver
Who can join
Under 5 Minutes, any sex, with Congenital Diaphragmatic Hernia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Congenital diaphragmatic hernia (CDH) is a severe birth defect, with a prevalence of 1:2000 to 1:3000 live births where a defect in the diaphragm results in, herniation of the abdominal contents into the chest with subsequent compression of the intrathoracic structures and respiratory insufficiency after birth. Respiratory insufficiency is managed with intubation and mechanical ventilation. In addition to managing respiratory insufficiency, intubation prevents entrainment of air into the intestines and further compression of the lungs and heart. Resuscitation of infants with CDH also involves placement of a nasogastric tube (NG) into the stomach for removal of entrained air and secretions. As part of routine resuscitation in infants with CDH intubation and NG tube placement are performed after the delivery personnel separates the baby from the placenta by cutting the umbilical cord. This study will assess the feasibility, maternal and fetal tolerance and the optimal approach to performing these initial steps of resuscitation with an intact umbilical cord. The investigators have randomly chosen 10 maternal and infant with congenital diaphragmatic hernia dyads to demonstrate feasibility as well as determine pitfalls and difficulties and the optimal approach to a complex resuscitation with an intact umbilical cord.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03242044
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Congenital Diaphragmatic Hernia
Currently open trials in the same condition.
- NCT05213676 — De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia · Phase 4 · recruiting
- NCT07187206 — Safety and Efficacy of FETO in CDH Phase III · Phase 3 · recruiting
- NCT07166172 — Prospective Registry for Long-term Outcomes Following FETO in Severe Left and Right CDH · NA · recruiting
- NCT06739356 — North American Fetal Therapy Network for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe · NA · recruiting
- NCT03138863 — Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO) · NA · recruiting
Other University of Colorado, Denver trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03242044 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Colorado, Denver
- Last refreshed: 14 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03242044.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing