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Stopping routine inhaled nitric oxide during newborn stabilization for congenital diaphragmatic hernia

Inhaled Nitric Oxide (iNO) for Congenital Diaphragmatic Hernia (CDH) - The "NoNO Trial" - a Multi-center, De-implementation, Stepped-wedge, Cluster-randomized Trial Within an Established Collaborative

Phase 4 Interventional The University of Texas Health Science Center, Houston · NCT05213676

This study will test whether stopping inhaled nitric oxide during initial resuscitation helps newborns with CDH avoid extracorporeal life support (ECLS) or death.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment600 (estimated)
Ages0 Months to 1 Month
SexAll
SponsorThe University of Texas Health Science Center, Houston Academic / other
Locations19 sites (Birmingham, Alabama and 18 other locations)
Trial IDNCT05213676 on ClinicalTrials.gov

What this trial studies

In this multicenter stepped-wedge cluster-randomized study, participating centers will follow their usual inhaled nitric oxide (iNO) protocols and then crossover at randomized times to de-implement iNO during the immediate postnatal resuscitation/stabilization period. The primary outcome is a composite of ECLS use and/or mortality, with secondary analyses of ECLS, mortality, oxygenation, and an economic analysis of incremental health system costs per prevented ECLS use or death. Eligible patients are live-born neonates with Bochdalek CDH diagnosed within the first month of life who are born at or transferred to a participating center within one week. Outcomes will be compared across clusters before and after de-implementation to determine clinical and cost effects.

Who should consider this trial

Good fit: Live-born newborns with Bochdalek congenital diaphragmatic hernia diagnosed within the first month of life who are born at or transferred to a participating CDH Study Group center within one week.

Not a fit: Babies diagnosed after one month, those with Morgagni hernia, those transferred to a participating center after one week, or those without potential access to iNO are not expected to benefit from this de-implementation approach in this study.

Why it matters

Potential benefit: If successful, stopping routine iNO during initial stabilization could reduce ECLS use and deaths and lower health-system costs.

How similar studies have performed: Prior randomized data have not shown clear benefit of iNO for CDH and routine use is controversial, so de-implementing iNO is a relatively novel, evidence-driven approach supported by observational concerns about iNO effectiveness.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Congenital Diaphragmatic HerniaCDHInhaled Nitric OxidePulmonary Hypertension
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.