NCT05213676 De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
| NCT ID | NCT05213676 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | The University of Texas Health Science Center, Houston |
| Condition | Congenital Diaphragmatic Hernia |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2030-10-31 |
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.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 600 participants in total. It began in 2025-11-01 with a primary completion date of 2030-10-31.
⚠ 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
The purpose of this study is to determine if de-implementation of inhaled nitric oxide (iNO) in the post-natal resuscitation/stabilization phase affects the composite outcome of extracorporeal life support (ECLS) use and/or mortality, as well as ECLS use, mortality, and/or oxygenation in congenital diaphragmatic hernia (CDH) newborns and to establish the cost-effectiveness of de-implementing iNO as a therapy in the postnatal resuscitation/stabilization phase of CDH management, which will be assessed as the incremental health system costs (savings) per prevented ECLS use and/or death.
Eligibility Criteria
Inclusion Criteria: * Postnatal, live born neonates with CDH a. Presence of associated or additional anomalies is acceptable for inclusion * Bochdalek hernia location (right or left) * Diagnosed prior to 1 month of life * Born within or transferred to (within 1 week of life) a CDHSG member center participating in the trial Exclusion Criteria: * CDH diagnosis after 1 month of age * Morgagni diaphragmatic hernia (central / anterior-medial diaphragmatic defect location) * Transferred to a CDH Study Group (CDHSG) member center after 1 week of life * Patients without potential access to iNO
Contact & Investigator
Matthew Harting, MD, MS, FACS
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center, Houston
Frequently Asked Questions
Who can join the NCT05213676 clinical trial?
This trial is open to participants of all sexes, aged 0 Months or older, up to 1 Month, studying Congenital Diaphragmatic Hernia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05213676 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05213676 currently recruiting?
Yes, NCT05213676 is actively recruiting participants. Contact the research team at Matthew.T.Harting@uth.tmc.edu for enrollment information.
Where is the NCT05213676 trial being conducted?
This trial is being conducted at Birmingham, United States, Little Rock, United States, Irvine, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT05213676 clinical trial?
NCT05213676 is sponsored by The University of Texas Health Science Center, Houston. The principal investigator is Matthew Harting, MD, MS, FACS at The University of Texas Health Science Center, Houston. The trial plans to enroll 600 participants.