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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

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My Bochdalek hernia is on the right or left side.

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I was diagnosed with my condition within the first month of life.

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My newborn has a diaphragmatic hernia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from birth through hospital discharge (upto 12 months from birth)

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).

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

903 Previous Clinical Trials

320,377 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals qualify for enrollment in this experiment?

"Patients with Morgagni hernias aged 0 to 1 month can apply for this clinical research, which is aiming to recruit around 600 participants."

Answered by AI

Does this research endeavor include individuals aged 55 and older?

"Based on the parameters of this trial, infants aged 0 to 1 month qualify for enrollment."

Answered by AI

Are there potential risks associated with discontinuing Inhaled Nitric Oxide (iNO)?

"Since De-implementation of Inhaled Nitric Oxide (iNO) is a Phase 4 trial, meaning this treatment has been approved, our experts rated its safety at 3 on a scale from 1 to 3."

Answered by AI

Is enrollment still available for this research initiative?

"As reported on clinicaltrials.gov, the recruitment period for this medical study has ended; it was initially posted in January 1st 2023 and last updated on Jan 27th 2022. Nevertheless, there are still 161 trials actively seeking participants at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Matthew T Harting 2025. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05213676.

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