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New treatment option for Congenital Diaphragmatic Hernia
Official title De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
ClinicalTrials.gov ID: NCT05213676
What this study is testing
What is Inhaled Nitric Oxide (iNO) use?
Inhaled Nitric Oxide (iNO) use is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for congenital diaphragmatic hernia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 1
You may be able to join if
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Little Rock, Arkansas, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- San Diego, California, United States
- Aurora, Colorado, United States
- Atlanta, Georgia, United States
- Indianapolis, Indiana, United States
- Louisville, Kentucky, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Portland, Oregon, United States
- Charleston, South Carolina, United States
- Memphis, Tennessee, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 months to 1 month. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Little Rock, Arkansas, United States; Irvine, California, United States; Los Angeles, California, United States; Palo Alto, California, United States; San Diego, California, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.