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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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10 July 2023 |
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Main ID: |
NCT05213676 |
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Date of registration:
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27/01/2022 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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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Date of first enrolment:
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January 1, 2025 |
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Target sample size:
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600 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT05213676 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Matthew Harting, MD, MS, FACS |
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Address:
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Telephone:
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713-500-7398 |
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Email:
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Matthew.T.Harting@uth.tmc.edu |
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Affiliation:
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Name:
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Matthew Harting, MD, MS, FACS |
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Address:
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Telephone:
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(713) 500-7398 |
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Email:
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Matthew.T.Harting@uth.tmc.edu |
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Affiliation:
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Name:
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Matthew Harting, MD, MS, FACS |
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Address:
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Telephone:
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Email:
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Affiliation:
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The University of Texas Health Science Center, Houston |
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Key inclusion & exclusion criteria
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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
Age minimum:
0 Months
Age maximum:
1 Month
Gender:
All
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Health Condition(s) or Problem(s) studied
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Congenital Diaphragmatic Hernia
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Intervention(s)
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Other: De-implementation of Inhaled Nitric Oxide (iNO) use
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Drug: Inhaled Nitric Oxide (iNO) use
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Primary Outcome(s)
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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)]
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Secondary Outcome(s)
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Number of participants that require Extracorporeal Life Support (ECLS) prior to discharge
[Time Frame: from birth through hospital discharge (upto 12 months from birth)]
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Change in oxygenation
[Time Frame: 1 hour after initiation of iNO use]
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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)]
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Number of participants that die prior to discharge
[Time Frame: from birth through hospital discharge (upto 12 months from birth)]
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Change in oxygenation
[Time Frame: 6 hours after initiation of iNO use]
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Secondary ID(s)
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HSC-MS-21-0603
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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