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RecruitingPhase 4

De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
0 Months to 1 Month
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether stopping the use of inhaled nitric oxide gas during care right after birth affects survival, blood oxygen levels, or the need for a machine to support the heart and lungs. It is for newborns with congenital diaphragmatic hernia (CDH), a birth defect with a hole in the muscle between the chest and belly. The study also looks at costs or savings.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Live-born newborns with CDH. Babies with other birth defects may also join.
  • The hole is toward the back and side of the muscle, on either the right or left (called a Bochdalek hernia).
  • CDH was diagnosed before 1 month of age.
  • Born at a CDH Study Group center taking part in the study, or moved there within the first week of life.

Who can't join

  • CDH was diagnosed after 1 month of age.
  • The hole is in the center or toward the front and middle of the muscle (called a Morgagni hernia).
  • Moved to a CDH Study Group center after the first week of life.
  • Inhaled nitric oxide gas would not be available for the baby.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (19)

AL

AR

CA

CO

GA

IN

KY

MA

MI

OR

SC

TN

TX

UT

WA