Inhaled Nitric Oxide for Diaphragmatic Hernia

Overseen By Ashley Ebanks

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Morgagni hernia, Late CDH diagnosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

600 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Inhaled Nitric Oxide (iNO) for diaphragmatic hernia?

Inhaled nitric oxide (iNO) may improve oxygen levels in some infants with congenital diaphragmatic hernia and pulmonary hypertension, but overall evidence of its benefit is limited. ^{1 2 3 4 5}

Is inhaled nitric oxide generally safe for humans?

Inhaled nitric oxide (iNO) is commonly used in infants with congenital diaphragmatic hernia (CDH), but the studies do not provide specific safety data. While it is widely used, the research does not clearly address its safety profile. ^{1 2 3 4 5}

How does the treatment inhaled nitric oxide (iNO) differ from other treatments for congenital diaphragmatic hernia?

Inhaled nitric oxide (iNO) is unique because it is administered directly into the lungs to help improve oxygen levels in infants with congenital diaphragmatic hernia (CDH), especially those with pulmonary hypertension (high blood pressure in the lungs). However, its effectiveness is not well-established, and it is often used when other treatments are not sufficient. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Matthew T. Harting, MD, MS

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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.

Inclusion Criteria

Having other medical conditions or abnormalities is allowed for participation.

My Bochdalek hernia is on the right or left side.

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

Exclusion Criteria

You do not have access to iNO (inhaled nitric oxide).

Transferred to a CDH Study Group (CDHSG) member center after 1 week of life

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Resuscitation and Stabilization

Centers use iNO per their usual protocol during the initial resuscitation period, which includes birth through stabilization and CDH repair

Birth through stabilization and CDH repair

De-implementation

Centers stop using iNO in the initial resuscitation period as part of the de-implementation strategy

Birth through stabilization and CDH repair

Follow-up

Participants are monitored for safety and effectiveness after treatment, including ECLS use and/or mortality until hospital discharge

Up to 12 months from birth

Treatment Details

Interventions

• De-implementation of Inhaled Nitric Oxide (iNO) use
• Inhaled Nitric Oxide (iNO)

Trial Overview 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.

Participant Groups

Group I: Inhaled Nitric Oxide (iNO) use Active Control 1 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) use Active Control 1 Intervention

The center will stop using iNO in the initial resuscitation period (defined as birth through stabilization and CDH repair).

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Early nitric oxide is not associated with improved outcomes in congenital diaphragmatic hernia. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Inhaled nitric oxide use in neonates with congenital diaphragmatic hernia. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Variability in Inhaled Nitric Oxide Use and Pulmonary Hypertension in Patients With Congenital Diaphragmatic Hernia. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Inhaled Nitric Oxide Is Associated with Improved Oxygenation in a Subpopulation of Infants with Congenital Diaphragmatic Hernia and Pulmonary Hypertension. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Inhaled nitric oxide and hypoxic respiratory failure in infants with congenital diaphragmatic hernia. The Neonatal Inhaled Nitric Oxide Study Group (NINOS). [2022]