Congenital Diaphragmatic Hernia study: Inhaled Nitric Oxide
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)?
This is an investigational approach being studied to see if stopping the use of inhaled nitric oxide helps newborns with congenital diaphragmatic hernia. is designed to relax the blood vessels in the lungs to help improve oxygen levels.
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
- This study is testing whether stopping inhaled nitric oxide after birth changes the need for a heart‑lung machine. It also looks at whether this change affects death rates in babies with congenital diaphragmatic hernia.
- Who it's for
- You may be able to join if you have a newborn baby diagnosed with congenital diaphragmatic hernia.
- What's involved
- You would receive the usual care but without inhaled nitric oxide. Doctors will watch your baby’s breathing and health and record the results.
- Time commitment
- The study follows the baby through the hospital stay with regular check‑ins.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at 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 locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.