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| Name | Class |
|---|---|
| University of Tennessee & LeBonheur Children's Hospital (UT-LBCH) | UNKNOWN |
| Children's Hospital of Orange County | OTHER |
| Medical University of South Carolina Children's Health (MUSC) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled Nitric Oxide (iNO) use | Active Comparator | 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. |
|
| De-implementation of Inhaled Nitric Oxide (iNO) use | Active Comparator | The center will stop using iNO in the initial resuscitation period (defined as birth through stabilization and CDH repair). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled Nitric Oxide (iNO) use | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from birth through hospital discharge (up to 12 months from birth) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew Harting, MD, MS, FACS | Contact | (713) 500-7398 | Matthew.T.Harting@uth.tmc.edu | |
| Ashley Ebanks | Contact | (832) 325-7234 | Ashley.Harmon@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Matthew Harting, MD, MS, FACS | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama & Children's Hospital of Alabama (UAB-CoA) | Recruiting | Birmingham | Alabama | 35233 | United States |
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| University of Michigan & CS Mott Children's Hospital (UM-CSMott) | UNKNOWN |
| Randall Children's Hospital-Portland (RCH) | UNKNOWN |
| Stanford University & Lucile Packard Children's Hospital (Stanford-LPCH) | UNKNOWN |
| Rady Children's Hospital, San Diego | OTHER |
| Boston Children's Hospital | OTHER |
| Indiana University & Riley Children's Hospital (IU-RiCH) | UNKNOWN |
| Norton Children's Hospital | OTHER |
| University of Utah & Primary Children's Hospital (Utah-PCH) | UNKNOWN |
| University of Washington & Seattle Children's Hospital (UW-SCH) | UNKNOWN |
| University of Alabama & Children's Hospital of Alabama (UAB-CoA) | UNKNOWN |
| University of Arkansas | OTHER |
| Vanderbilt University Medical Center | OTHER |
| University of Southern California & Children's Hospital Los Angeles (USC-CHLA) | UNKNOWN |
| Emory University & Children's Healthcare of Atlanta (CHOA) | UNKNOWN |
| Children's Hospital Colorado | OTHER |
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.
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|
| De-implementation of Inhaled Nitric Oxide (iNO) use | Other | The center will stop using iNO in the initial resuscitation period (defined as birth through stabilization and CDH repair). |
|
| 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. | 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. | 6 hours after initiation of iNO use |
| Total cost of initial inpatient care from birth through hospital discharge, per center | from birth through hospital discharge (up to 12 months from birth) |
| University of Arkansas & Arkansas Children's Hospital (UA-ACH) | Recruiting | Little Rock | Arkansas | 72202 | United States |
|
| University of California-Irvine & Children's Hospital of Orange County (UC-CHOC) | Recruiting | Irvine | California | 92868 | United States |
|
| University of Southern California & Children's Hospital Los Angeles (USC-CHLA) | Recruiting | Los Angeles | California | 90027 | United States |
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| Stanford University & Lucile Packard Children's Hospital (Stanford-LPCH) | Recruiting | Palo Alto | California | 94304 | United States |
|
| University of California, San Diego & Rady Children's Hospital (UCSD-Rady) | Recruiting | San Diego | California | 92123 | United States |
|
| University of Colorado & Children's Hospital of Colorado (CU-CHC) | Recruiting | Aurora | Colorado | 80045 | United States |
|
| Emory University & Children's Healthcare of Atlanta (CHOA) | Recruiting | Atlanta | Georgia | 30322 | United States |
|
| Indiana University & Riley Children's Hospital (IU-RiCH) | Recruiting | Indianapolis | Indiana | 46202 | United States |
|
| University of Louisville & Norton Children's Hospital (UL-NCH) | Recruiting | Louisville | Kentucky | 40202 | United States |
|
| Harvard University & Boston Children's Hospital (Harvard-BCH) | Recruiting | Boston | Massachusetts | 02115 | United States |
|
| University of Michigan & CS Mott Children's Hospital (UM-CSMott) | Recruiting | Ann Arbor | Michigan | 48109 | United States |
|
| Randall Children's Hospital-Portland (RCH) | Recruiting | Portland | Oregon | 97227 | United States |
|
| Medical University of South Carolina Children's Health (MUSC) | Recruiting | Charleston | South Carolina | 29425 | United States |
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| University of Tennessee & LeBonheur Children's Hospital (UT-LBCH) | Recruiting | Memphis | Tennessee | 38105 | United States |
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| Vanderbilt University & Vanderbilt University Medical Center (VUMC) | Recruiting | Nashville | Tennessee | 37232 | United States |
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| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
|
| University of Utah & Primary Children's Hospital (Utah-PCH) | Recruiting | Salt Lake City | Utah | 84108 | United States |
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| University of Washington & Seattle Children's Hospital (UW-SCH) | Recruiting | Seattle | Washington | 98105 | United States |
|
| ID | Term |
|---|---|
| D065630 | Hernias, Diaphragmatic, Congenital |
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006548 | Hernia, Diaphragmatic |
| D000082122 | Internal Hernia |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D007288 | Inosine |
| ID | Term |
|---|---|
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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