De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia

Conditions

• Congenital Diaphragmatic Hernia

Eligibility Criteria

Sex

ALL

Age

0 Months - 1 Month

Healthy Volunteers

Not accepted

Interventions

• 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.
• 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).

Study Details

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.

Key Dates

Start date

Nov 1, 2025

Status verified

Feb 2026

Primary completion

Oct 31, 2030

Completion

Apr 30, 2031

Study Design

Enrollment

600 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Active Comparator: 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.
• Active Comparator: 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).

Primary Outcome Measure

Number of participants who require Extracorporeal Life Support (ECLS) and/or who die prior to discharge [ Time Frame: from birth through hospital discharge (up to 12 months from birth) ]

Central Contacts

• Matthew Harting, MD, MS, FACS
  (713) 500-7398
  [email protected]
• Ashley Ebanks
  (832) 325-7234
  [email protected]

Locations (19)

Find similar trials in Birmingham, AL

Related Studies

• Diaphragmatic Hernia Research & Exploration, Advancing Molecular Science
  Recruiting · Columbia University · Chicago, Illinois
• Fetoscopic Endoluminal Tracheal Occlusion
  Recruiting · University of Colorado, Denver · Aurora, Colorado
• Fetal Endotracheal Occlusion (FETO) in the Resolution of Pulmonary Hypertension in Fetuses With Severe CDH
  Recruiting · Michael A Belfort · Houston, Texas
• Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)
  Recruiting · Hanmin Lee · San Francisco, California