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RECRUITING Phase 4

De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia

NCT05213676 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 600 participants
Start Date 2025-11-01
Est. Completion 2031-04-30
Phase Phase 4

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05213676

The ClinicalTrials.gov registry entry for NCT05213676 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 811 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05213676 reports 19 study locations spanning 15 distinct geographic areas — top geographies include California, Tennessee, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05213676?

This trial is sponsored by The University of Texas Health Science Center, Houston, which has 811 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial