De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia

This study is looking at whether stopping the use of inhaled nitric oxide (iNO) during the initial care of newborns with congenital diaphragmatic hernia (CDH) is effective. CDH is a birth defect where there's a hole in the diaphragm, the muscle that separates the chest from the abdomen. Researchers want to see if de-implementing iNO affects the need for extracorporeal life support (ECLS), a machine that acts as artificial heart and lungs, or the risk of death before leaving the hospital. They are also studying the cost-effectiveness of this approach. You might be able to join if you are a newborn (up to 1 month old) with CDH, including those with other health issues, and have a specific type of hernia called a Bochdalek hernia. The study aims to enroll 600 participants, but its current status is unclear.

Study design
This is a multi-center study where hospitals will first use iNO as usual, then switch to not using it. The timing of this switch will be randomly determined for each hospital.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from birth through hospital discharge, up to 12 months from birth, to assess outcomes.

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NCT05213676

De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia

Recruiting
PHASE4Ages 0–1InterventionalTreatment
The University of Texas Health Science Center, Houston
~600 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:Inhaled Nitric Oxide (iNO) useDe-implementation of Inhaled Nitric Oxide (iNO) use

At a glance

Recruiting sites
19 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants who require Extracorporeal Life Support (ECLS) and/or who die prior to discharge
Measured over from birth through hospital discharge (up to 12 months from birth)
Congenital Diaphragmatic Hernia
19 sites across 15 states
California4
Tennessee2
Alabama1
Arkansas1
Colorado1
Georgia1
Indiana1
Kentucky1
  • Matthew Harting, MD, MS, FACS · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

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Eligibility criteria

Inclusion

Postnatal, live born neonates with CDH
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

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
  • Number of participants who require Extracorporeal Life Support (ECLS) and/or who die prior to dischargefrom birth through hospital discharge (up to 12 months from birth)

    The primary outcome is the composite outcome of ECLS use and/or mortality.