Congenital Diaphragmatic Hernia
Conditions
Keywords
CDH, Inhaled Nitric Oxide, Pulmonary Hypertension
Brief summary
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.
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.
Interventions
DRUGInhaled 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.
OTHERDe-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).
Sponsors
The University of Texas Health Science Center, Houston
University of Tennessee & LeBonheur Children's Hospital (UT-LBCH)
Children's Hospital of Orange County
Medical University of South Carolina Children's Health (MUSC)
University of Michigan & CS Mott Children's Hospital (UM-CSMott)
Randall Children's Hospital-Portland (RCH)
Stanford University & Lucile Packard Children's Hospital (Stanford-LPCH)
Rady Children's Hospital, San Diego
Boston Children's Hospital
Indiana University & Riley Children's Hospital (IU-RiCH)
Norton Children's Hospital
University of Utah & Primary Children's Hospital (Utah-PCH)
University of Washington & Seattle Children's Hospital (UW-SCH)
University of Alabama & Children's Hospital of Alabama (UAB-CoA)
University of Arkansas
Vanderbilt University Medical Center
University of Southern California & Children's Hospital Los Angeles (USC-CHLA)
Emory University & Children's Healthcare of Atlanta (CHOA)
Children's Hospital Colorado
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model 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.
Eligibility
Sex/Gender
ALL
Age
0 Months to 1 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who require Extracorporeal Life Support (ECLS) and/or who die prior to discharge | from birth through hospital discharge (up to 12 months from birth) | The primary outcome is the composite outcome of ECLS use and/or mortality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who require Extracorporeal Life Support (ECLS) prior to discharge | from birth through hospital discharge (up to 12 months from birth) | — |
| Number of participants who die prior to discharge | from birth through hospital discharge (up to 12 months from birth) | — |
| Change in oxygenation | 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. |
| Total cost of initial inpatient care from birth through hospital discharge, per center | from birth through hospital discharge (up to 12 months from birth) | — |
Countries
United States
Contacts
CONTACTMatthew Harting, MD, MS, FACS
CONTACTAshley Ebanks
PRINCIPAL_INVESTIGATORMatthew Harting, MD, MS, FACS
The University of Texas Health Science Center, Houston
Outcome results
None listed