Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
Recruiting
Phase 4
Interventional Study
Congenital Diaphragmatic Hernia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 0 Months – 1 Month
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 600 (estimated)
- Sponsor
- The University of Texas Health Science Center, Houston · Other
Who this trial is looking for
This trial is looking for newborns with congenital diaphragmatic hernia (CDH). Participants will be part of a study to see if a treatment is beneficial and cost-effective during their early care.
Are You a Good Fit for This Trial?
You may be able to join if
- I am a live born neonate with CDH.
- I have a Bochdalek hernia.
- I was diagnosed with CDH before I was 1 month old.
- I was born at or transferred to a participating CDH center within 1 week of life.
You may not be able to join if
- I was diagnosed with CDH after 1 month of age.
- I have a Morgagni hernia.
- I was transferred to a CDH center after 1 week of life.
- I do not have access to inhaled nitric oxide.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 a…
Trial Locations
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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 cente…
Contacts