A Phase 4 interventional study of Inhaled Nitric Oxide (iNO) use and De-implementation of Inhaled Nitric Oxide (iNO) use in Congenital Diaphragmatic Hernia, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 19 sites in United States. Open to participants aged 0 Months to 1 Month. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by The University of Texas Health Science Center, Houston · Phase 4, Interventional, and Treatment
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.
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.
86 studies on the registry are indexed under Hernias, Diaphragmatic, Congenital; 39 are open to participants now.
This study's planned enrollment of 900 is above the median of 30 across 62 interventional studies indexed under Hernias, Diaphragmatic, Congenital.
Browse Hernias, Diaphragmatic, Congenital studies →The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Postnatal, live born neonates with CDH
a. Presence of associated or additional anomalies is acceptable for inclusion
Exclusion Criteria:
The center will use iNO per their usual protocol in the initial resuscitation period (defined as birth through stabilization and CDH repair). No center will alter any component of their standard clinical practice guideline or protocol governing CDH care.
Drug: Inhaled Nitric Oxide (iNO) use
The center will stop using iNO in the initial resuscitation period (defined as birth through stabilization and CDH repair).
Other: De-implementation of Inhaled Nitric Oxide (iNO) use
The center will use iNO per their usual protocol in the initial resuscitation period (defined as birth through stabilization and CDH repair). No center will alter any component of their standard clinical practice guideline or protocol governing CDH care.
The center will stop using iNO in the initial resuscitation period (defined as birth through stabilization and CDH repair).
Number of participants who require Extracorporeal Life Support (ECLS) and/or who die prior to discharge
The primary outcome is the composite outcome of ECLS use and/or mortality.
Time frame: from birth through hospital discharge (up to 12 months from birth)
Number of participants who require Extracorporeal Life Support (ECLS) prior to discharge
Time frame: from birth through hospital discharge (up to 12 months from birth)
Number of participants who die prior to discharge
Time frame: from birth through hospital discharge (up to 12 months from birth)
Change in oxygenation
For the iNO de-implementation arm, participants will be assessed 1 hour after the time when iNO would have been initiated, per the protocol of the center.
Time frame: 1 hour after initiation of iNO use
Change in oxygenation
For the iNO de-implementation arm, participants will be assessed 6 hours after the time when iNO would have been initiated, per the protocol of the center.
Time frame: 6 hours after initiation of iNO use
Total cost of initial inpatient care from birth through hospital discharge, per center
Time frame: from birth through hospital discharge (up to 12 months from birth)
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Oct 2030, 59 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Hernias, Diaphragmatic, Congenital →
The University of Texas Health Science Center, Houston →