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

Study on the Effects of Stopping a Type of Gas Used in Treatment in Newborns with a Condition Affecting Breathing

B
Brian Gray, MD

Primary Investigator

Enrolling By Invitation
1 month or below
All
Phase N/A
25 participants needed
1 Location

Brief description of study

The purpose of this study is to Determine if deimplementation of iNO in the post-natal resuscitation/stabilization phase affects the composite outcome of ECLS use and/or mortality, as well as ECLS use, mortality, and/or oxygenation in CDH newborns and to establish the cost-effectiveness of deimplementing 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.

THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

In this multi-center study, centers will use iNO per their usual protocol, and centers will then crossover to iNO de-implementation (that is, at the time of crossover, centers will stop using iNO in the initial resuscitation period). A stepped-wedge crossover study design will be used, and the timing of crossover will be cluster randomized at the level of the center.

PRIMARY OBJECTIVES:

  • Number of participants that require Extracorporeal Life Support (ECLS) and/or that die prior to discharge

SECONDARY OBJECTIVES:

  • Number of participants that require Extracorporeal Life Support (ECLS) prior to discharge
  • Number of participants that die prior to discharge
  • Change in oxygenation
  • Change in oxygenation
  • Total cost of initial inpatient care from birth through hospital discharge, per center

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Congenital Diaphragmatic Hernia, Riley
  • Age: 1 month or below
  • Gender: All

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

This study investigates the effects of stopping the use of inhaled nitric oxide (iNO) during the early treatment of newborns with congenital diaphragmatic hernia (CDH). CDH is a condition where there is an opening in the diaphragm, allowing organs from the belly to move into the chest, which can affect breathing. The study aims to see if stopping iNO affects the need for special life support machines or the chance of survival.

In this study, different hospitals will either continue using iNO as they usually do or stop using it during the first treatment period for newborns with CDH. The study will look at how these changes affect the need for life support, survival rates, and the costs of care. The study uses a special design where hospitals change their practice at different times, and these changes are planned randomly.

  • Who can participate: Newborns diagnosed with the condition affecting breathing within the first month of life can participate, provided they are born in or transferred to a participating center within the first week. Babies with additional anomalies can also join.
  • Study details: Participants will receive routine care for the condition, with some centers stopping the use of the gas during early treatment. The study will observe how this affects the need for life support and other outcomes.
Updated on 24 Mar 2026. Study ID: SURG-UTHSC-NONO-TRIAL, 28100
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only