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Vasodilator

Inhaled Nitric Oxide for Diaphragmatic Hernia

Phase 4
Waitlist Available
Led By Matthew Harting, MD, MS, FACS
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Bochdalek hernia location (right or left)
Diagnosed prior to 1 month of life
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from birth through hospital discharge (upto 12 months from birth)
Awards & highlights

Study Summary

This trial will test whether or not a common treatment for newborns with a specific birth defect is actually effective, and also establish how much money could be saved if the treatment is stopped.

Who is the study for?
This trial is for newborns with a type of hernia called Bochdalek, diagnosed before they turn one month old. They must be born at or transferred to a participating center within their first week of life. Babies without access to the tested treatment or diagnosed after one month, or those with Morgagni hernia are not eligible.Check my eligibility
What is being tested?
The study aims to see if stopping the use of inhaled Nitric Oxide (iNO) during early care affects survival rates and the need for extracorporeal life support (ECLS). It also looks at whether this change can save healthcare costs without compromising patient outcomes.See study design
What are the potential side effects?
While specific side effects are not listed here, iNO generally may cause issues like low blood pressure, headaches, and possibly increased bleeding risk. The trial will monitor any adverse effects from its use or discontinuation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My Bochdalek hernia is on the right or left side.
Select...
I was diagnosed with my condition within the first month of life.
Select...
My newborn has a diaphragmatic hernia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from birth through hospital discharge (upto 12 months from birth)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from birth through hospital discharge (upto 12 months from birth) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants that require Extracorporeal Life Support (ECLS) and/or that die prior to discharge
Secondary outcome measures
Change in oxygenation
Number of participants that die prior to discharge
Number of participants that require Extracorporeal Life Support (ECLS) prior to discharge
+1 more

Trial Design

2Treatment groups
Active Control
Group I: Inhaled Nitric Oxide (iNO) useActive Control1 Intervention
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.
Group II: De-implementation of Inhaled Nitric Oxide (iNO) useActive Control1 Intervention
The center will stop using iNO in the initial resuscitation period (defined as birth through stabilization and CDH repair).

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
912 Previous Clinical Trials
323,122 Total Patients Enrolled
Matthew Harting, MD, MS, FACSPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Media Library

Inhaled Nitric Oxide (iNO) (Vasodilator) Clinical Trial Eligibility Overview. Trial Name: NCT05213676 — Phase 4
Congenital Diaphragmatic Hernia Research Study Groups: Inhaled Nitric Oxide (iNO) use, De-implementation of Inhaled Nitric Oxide (iNO) use
Congenital Diaphragmatic Hernia Clinical Trial 2023: Inhaled Nitric Oxide (iNO) Highlights & Side Effects. Trial Name: NCT05213676 — Phase 4
Inhaled Nitric Oxide (iNO) (Vasodilator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05213676 — Phase 4
~400 spots leftby Dec 2029
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