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NCT05213676 · ClinicalTrials.gov registry record · Phase 4
De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
A Phase 4 study of Congenital Diaphragmatic Hernia, sponsored by The University of Texas Health Science Center, Houston.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 600
- Enrollment target
- 19
- Study locations
NCT05213676: Recruiting Phase 4 study of Congenital Diaphragmatic Hernia, sponsored by The University of Texas Health Science Center, Houston.
NCT05213676 is a Phase 4 study of Congenital Diaphragmatic Hernia that is actively recruiting participants, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 600 participants, above the 169-participant average among 22 other Congenital Diaphragmatic Hernia trials with a reported enrollment target (255% higher). The trial reports 19 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05213676, a Phase 4 study of Congenital Diaphragmatic Hernia, is actively recruiting participants, sponsored by The University of Texas Health Science Center, Houston.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 600 participants
- Enrollment target
- 19
- Study locations
Study 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.
Primary Outcome
The primary outcome is the composite outcome of ECLS use and/or mortality.
Conditions Studied
Interventions
- DRUG Inhaled Nitric Oxide (iNO) use
- OTHER De-implementation of Inhaled Nitric Oxide (iNO) use
Study Locations (19)
California
- University of California-Irvine & Children's Hospital of Orange County (UC-CHOC) - Irvine
- University of Southern California & Children's Hospital Los Angeles (USC-CHLA) - Los Angeles
- Stanford University & Lucile Packard Children's Hospital (Stanford-LPCH) - Palo Alto
- University of California, San Diego & Rady Children's Hospital (UCSD-Rady) - San Diego
Tennessee
- University of Tennessee & LeBonheur Children's Hospital (UT-LBCH) - Memphis
- Vanderbilt University & Vanderbilt University Medical Center (VUMC) - Nashville
Alabama
- University of Alabama & Children's Hospital of Alabama (UAB-CoA) - Birmingham
Arkansas
- University of Arkansas & Arkansas Children's Hospital (UA-ACH) - Little Rock
Colorado
- University of Colorado & Children's Hospital of Colorado (CU-CHC) - Aurora
Georgia
- Emory University & Children's Healthcare of Atlanta (CHOA) - Atlanta
Indiana
- Indiana University & Riley Children's Hospital (IU-RiCH) - Indianapolis
Kentucky
- University of Louisville & Norton Children's Hospital (UL-NCH) - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2025-11-01 |
| Est. Completion | 2031-04-30 |
| Phase | Phase 4 |
What NCT05213676 shows while recruiting
NCT05213676 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 169-participant average among 22 other Congenital Diaphragmatic Hernia trials with a reported enrollment target (255% higher).
The record links to 1 condition, with Congenital Diaphragmatic Hernia appearing as the primary indexed condition, and to 2 interventions - of which Inhaled Nitric Oxide (iNO) use is the first listed.
NCT05213676 lists 19 locations in 15 states (California, Tennessee, Alabama).
Frequently Asked Questions
What is clinical trial NCT05213676 about?
NCT05213676 is a clinical study titled "De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia". 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 ...
What is the current status of trial NCT05213676?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 600 participants. The study started on 2025-11-01. Estimated completion is 2031-04-30.
What conditions does trial NCT05213676 study?
This clinical trial studies the following conditions: Congenital Diaphragmatic Hernia.
What interventions are being tested in trial NCT05213676?
The interventions under investigation include: Inhaled Nitric Oxide (iNO) use (DRUG), De-implementation of Inhaled Nitric Oxide (iNO) use (OTHER).
Who is sponsoring clinical trial NCT05213676?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05213676 being conducted?
This trial has 19 study locations across Alabama, Arkansas, California, Colorado, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Congenital Diaphragmatic Hernia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05213676's enrollment target sits among peer trials
600 2nd of 22 the highest of 22 other Congenital Diaphragmatic Hernia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Congenital Diaphragmatic Hernia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)
RECRUITING · NA
-
Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)
RECRUITING · NA
-
A Trial of Phosphodiesterase-5 Inhibitor in Neonatal Congenital Diaphragmatic Hernia (TOP-CDH)
RECRUITING · Phase 2
-
Safety and Efficacy of FETO in CDH: A Phase III Trial
RECRUITING · NA
-
Trial of FETO for Severe Congenital Diaphragmatic Hernia
RECRUITING · NA
-
Fetal Endoscopic Tracheal Occlusion for CDH (CDH)
RECRUITING · NA
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