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Could less treatment be better? new study questions routine use of inhaled nitric oxide in CDH babies

NCT ID NCT05213676

Knowledge-focused Sponsor: The University of Texas Health Science Center, Houston Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times

Summary

This study looks at whether not using inhaled nitric oxide (iNO) in newborns with congenital diaphragmatic hernia (CDH) leads to better outcomes, like fewer needing life support or dying. About 600 babies from multiple hospitals will be included. The goal is to see if stopping this routine treatment is safe, effective, and saves money.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Apr 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 months to 1 month

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

congenital diaphragmatic hernia pulmonary hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Congenital diaphragmatic hernia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Emory University & Children's Healthcare of Atlanta (CHOA)

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Harvard University & Boston Children's Hospital (Harvard-BCH)

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Indiana University & Riley Children's Hospital (IU-RiCH)

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Medical University of South Carolina Children's Health (MUSC)

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Randall Children's Hospital-Portland (RCH)

    RECRUITING

    Portland, Oregon, 97227, United States

  • Stanford University & Lucile Packard Children's Hospital (Stanford-LPCH)

    RECRUITING

    Palo Alto, California, 94304, United States

  • The University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Alabama & Children's Hospital of Alabama (UAB-CoA)

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of Arkansas & Arkansas Children's Hospital (UA-ACH)

    RECRUITING

    Little Rock, Arkansas, 72202, United States

  • University of California, San Diego & Rady Children's Hospital (UCSD-Rady)

    RECRUITING

    San Diego, California, 92123, United States

  • University of California-Irvine & Children's Hospital of Orange County (UC-CHOC)

    RECRUITING

    Irvine, California, 92868, United States

  • University of Colorado & Children's Hospital of Colorado (CU-CHC)

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Louisville & Norton Children's Hospital (UL-NCH)

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of Michigan & CS Mott Children's Hospital (UM-CSMott)

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Southern California & Children's Hospital Los Angeles (USC-CHLA)

    RECRUITING

    Los Angeles, California, 90027, United States

  • University of Tennessee & LeBonheur Children's Hospital (UT-LBCH)

    RECRUITING

    Memphis, Tennessee, 38105, United States

  • University of Utah & Primary Children's Hospital (Utah-PCH)

    RECRUITING

    Salt Lake City, Utah, 84108, United States

  • University of Washington & Seattle Children's Hospital (UW-SCH)

    RECRUITING

    Seattle, Washington, 98105, United States

  • Vanderbilt University & Vanderbilt University Medical Center (VUMC)

    RECRUITING

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.