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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

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ClinicalTrials.gov Identifier: NCT05213676
Recruitment Status : Not yet recruiting
First Posted : January 28, 2022
Last Update Posted : January 28, 2022
Sponsor:
Information provided by (Responsible Party):
Matthew Tihen Harting, The University of Texas Health Science Center, Houston

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Congenital Diaphragmatic Hernia Drug: Inhaled Nitric Oxide (iNO) use Other: De-implementation of Inhaled Nitric Oxide (iNO) use Phase 4

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: In this multi-center study, centers will use iNO per their usual protocol, and centers will then crossover to iNO deimplementation (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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : January 1, 2023
Estimated Primary Completion Date : January 30, 2028
Estimated Study Completion Date : January 30, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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.
 Drug: 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.
Active Comparator: De-implementation of 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 stop using iNO in the initial resuscitation period (defined as birth through stabilization and CDH repair).


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants that require Extracorporeal Life Support (ECLS) and/or that die prior to discharge [ Time Frame: from birth through hospital discharge (upto 12 months from birth) ]
    The primary outcome is the composite outcome of ECLS use and/or mortality.


Secondary Outcome Measures :
  1. Number of participants that require Extracorporeal Life Support (ECLS) prior to discharge [ Time Frame: from birth through hospital discharge (upto 12 months from birth) ]
  2. Number of participants that die prior to discharge [ Time Frame: from birth through hospital discharge (upto 12 months from birth) ]
  3. Change in oxygenation [ Time Frame: 1 hour after initiation of iNO use ]
    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.

  4. Change in oxygenation [ Time Frame: 6 hours after initiation of iNO use ]
    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.

  5. Total cost of initial inpatient care from birth through hospital discharge, per center [ Time Frame: from birth through hospital discharge (upto 12 months from birth) ]

Eligibility Criteria
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Ages Eligible for Study:   0 Months to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05213676


Contacts
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Contact: Matthew Harting, MD, MS, FACS (713) 500-7398 Matthew.T.Harting@uth.tmc.edu
Contact: Ashley Ebanks (832) 325-7234 Ashley.Harmon@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Contact: Matthew Harting, MD, MS, FACS    713-500-7398    Matthew.T.Harting@uth.tmc.edu   
Contact: Ashley Ebanks    (832) 325-7234    Ashley.Harmon@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Matthew Harting, MD, MS, FACS The University of Texas Health Science Center, Houston
More Information
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Responsible Party: Matthew Tihen Harting, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT05213676    
Other Study ID Numbers: HSC-MS-21-0603
First Posted: January 28, 2022    Key Record Dates
Last Update Posted: January 28, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Matthew Tihen Harting, The University of Texas Health Science Center, Houston:
CDH
Inhaled Nitric Oxide
Pulmonary hypertension
Additional relevant MeSH terms:
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Hernias, Diaphragmatic, Congenital
Hernia
Hernia, Diaphragmatic
Pathological Conditions, Anatomical
Internal Hernia
Congenital Abnormalities
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents