What side effects are associated with this type of intervention?

Inhaled nitric oxide (iNO) is commonly used to improve oxygenation in patients with Congenital Diaphragmatic Hernia (CDH) by relaxing pulmonary blood vessels. Known side effects of iNO include an increased risk of renal impairment, although it does not significantly increase the risk of bleeding, methemoglobin formation, or nitrogen dioxide formation. Other treatments for CDH, such as mechanical ventilation and extracorporeal membrane oxygenation (ECMO), also carry risks including infection, bleeding, and organ damage. It is important to monitor patients closely for these potential adverse effects.

What prior FDA approvals exist?

Inhaled nitric oxide (iNO) has been used as a treatment for Congenital Diaphragmatic Hernia (CDH) to improve oxygenation by relaxing pulmonary blood vessels. However, the 'NoNO Trial' is investigating the deimplementation of iNO in the post-natal resuscitation/stabilization phase to assess its impact on outcomes such as ECLS use and mortality. Other FDA-approved treatments for CDH focus on surgical repair and supportive care, but specific vasodilators similar to iNO have not been highlighted in the provided context.

What other types of research exist?

Promising novel alternatives to the deimplementation of inhaled nitric oxide (iNO) for Congenital Diaphragmatic Hernia (CDH) patients in 2024 may include advanced non-invasive ventilation strategies, the use of other pulmonary vasodilators such as sildenafil, and the potential application of extracorporeal membrane oxygenation (ECMO) as a bridge to recovery. Additionally, optimizing conventional therapies and exploring new pharmacological agents targeting pulmonary hypertension and improving lung function could be beneficial.

← Back to Search

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

Must not have

Morgagni diaphragmatic hernia (central / anterior-medial diaphragmatic defect location)

CDH diagnosis after 1 month of age

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

All Individual Drugs Already Approved

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is studying what happens when doctors stop using a gas treatment called inhaled Nitric Oxide (iNO) in newborns with severe breathing problems due to Congenital Diaphragmatic Hernia (CDH). The gas treatment helps open up blood vessels in the lungs to improve oxygen levels. Researchers want to see if stopping this treatment affects survival rates and the need for advanced life support, as well as its cost-effectiveness. Inhaled nitric oxide (iNO) has been used to treat respiratory failure in newborns, including those with congenital diaphragmatic hernia (CDH), to improve oxygenation.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a hernia in the front part of my diaphragm.

Select...

My CDH was diagnosed when I was older than 1 month.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants that require Extracorporeal Life Support (ECLS) and/or that die prior to discharge

Secondary study objectives

Change in oxygenation

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Inhaled nitric oxide (iNO) is a common treatment for Congenital Diaphragmatic Hernia (CDH) that works by relaxing pulmonary blood vessels, thereby improving oxygenation. This is particularly important for CDH patients who often suffer from pulmonary hypertension and compromised lung function. By reducing pulmonary vascular resistance, iNO enhances blood flow to the lungs, improving oxygenation and reducing cardiac strain. This mechanism is crucial during the postnatal resuscitation and stabilization phase, where optimizing oxygenation can be life-saving. Other treatments for CDH include surgical repair of the diaphragmatic defect and supportive care such as mechanical ventilation and extracorporeal membrane oxygenation (ECMO).