De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia

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.

Conditions

• Congenital Diaphragmatic Hernia

Interventions

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.

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).

Sponsors & Collaborators

• University of Tennessee & LeBonheur Children's Hospital (UT-LBCH)

  collaborator UNKNOWN

• Children's Hospital of Orange County

  collaborator OTHER

• Medical University of South Carolina Children's Health (MUSC)

  collaborator UNKNOWN

• University of Michigan & CS Mott Children's Hospital (UM-CSMott)

  collaborator UNKNOWN

• Randall Children's Hospital-Portland (RCH)

  collaborator UNKNOWN

• Stanford University & Lucile Packard Children's Hospital (Stanford-LPCH)

  collaborator UNKNOWN

• Rady Children's Hospital, San Diego

  collaborator OTHER

• Boston Children's Hospital

  collaborator OTHER

• Indiana University & Riley Children's Hospital (IU-RiCH)

  collaborator UNKNOWN

• Norton Children's Hospital

  collaborator OTHER

• University of Utah & Primary Children's Hospital (Utah-PCH)

  collaborator UNKNOWN

• University of Washington & Seattle Children's Hospital (UW-SCH)

  collaborator UNKNOWN

• University of Alabama & Children's Hospital of Alabama (UAB-CoA)

  collaborator UNKNOWN

• University of Arkansas

  collaborator OTHER

• Vanderbilt University Medical Center

  collaborator OTHER

• University of Southern California & Children's Hospital Los Angeles (USC-CHLA)

  collaborator UNKNOWN

• Emory University & Children's Healthcare of Atlanta (CHOA)

  collaborator UNKNOWN

• Children's Hospital Colorado

  collaborator OTHER

• The University of Texas Health Science Center, Houston

  lead OTHER

Principal Investigators

• Matthew Harting, MD, MS, FACS · The University of Texas Health Science Center, Houston

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

0 Months

Max Age

1 Month

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-01

Primary Completion

2030-10-31

Completion

2031-04-30

FDA Drug

Yes

Countries

• United States

Study Locations