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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

Primary Purpose

Congenital Diaphragmatic Hernia

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Inhaled Nitric Oxide (iNO) use
De-implementation of Inhaled Nitric Oxide (iNO) use
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Diaphragmatic Hernia focused on measuring CDH, Inhaled Nitric Oxide, Pulmonary hypertension

Eligibility Criteria

0 Months - 1 Month (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Inhaled Nitric Oxide (iNO) use

De-implementation of Inhaled Nitric Oxide (iNO) use

Arm Description

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).

Outcomes

Primary Outcome Measures

Number of participants that require Extracorporeal Life Support (ECLS) and/or that die prior to discharge
The primary outcome is the composite outcome of ECLS use and/or mortality.

Secondary Outcome Measures

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

Full Information

First Posted
January 27, 2022
Last Updated
June 27, 2023
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT05213676
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2025 (Anticipated)
Primary Completion Date
December 31, 2029 (Anticipated)
Study Completion Date
December 31, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Diaphragmatic Hernia
Keywords
CDH, Inhaled Nitric Oxide, Pulmonary hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inhaled Nitric Oxide (iNO) use
Arm Type
Active Comparator
Arm Description
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.
Arm Title
De-implementation of Inhaled Nitric Oxide (iNO) use
Arm Type
Active Comparator
Arm Description
The center will stop using iNO in the initial resuscitation period (defined as birth through stabilization and CDH repair).
Intervention Type
Drug
Intervention Name(s)
Inhaled Nitric Oxide (iNO) use
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
De-implementation of Inhaled Nitric Oxide (iNO) use
Intervention Description
The center will stop using iNO in the initial resuscitation period (defined as birth through stabilization and CDH repair).
Primary Outcome Measure Information:
Title
Number of participants that require Extracorporeal Life Support (ECLS) and/or that die prior to discharge
Description
The primary outcome is the composite outcome of ECLS use and/or mortality.
Time Frame
from birth through hospital discharge (upto 12 months from birth)
Secondary Outcome Measure Information:
Title
Number of participants that require Extracorporeal Life Support (ECLS) prior to discharge
Time Frame
from birth through hospital discharge (upto 12 months from birth)
Title
Number of participants that die prior to discharge
Time Frame
from birth through hospital discharge (upto 12 months from birth)
Title
Change in oxygenation
Description
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
Title
Change in oxygenation
Description
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
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Months
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Harting, MD, MS, FACS
Phone
(713) 500-7398
Email
Matthew.T.Harting@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley Ebanks
Phone
(832) 325-7234
Email
Ashley.Harmon@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Harting, MD, MS, FACS
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Harting, MD, MS, FACS
Phone
713-500-7398
Email
Matthew.T.Harting@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Ashley Ebanks
Phone
(832) 325-7234
Email
Ashley.Harmon@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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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