Inhaled Nitric Oxide for Diaphragmatic Hernia

Recruiting in Palo Alto (17 mi)

Overseen byMatthew T. Harting, MD, MS

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: The University of Texas Health Science Center, Houston

No Placebo Group

Prior Safety Data

Trial Summary

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.

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.

+2 more

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.

+1 more

Participant Groups

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.

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).