Inhaled Nitric Oxide for Diaphragmatic Hernia
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?
Is inhaled nitric oxide generally safe for humans?
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.12345
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Initial Resuscitation and Stabilization
Centers use iNO per their usual protocol during the initial resuscitation period, which includes birth through stabilization and CDH repair
De-implementation
Centers stop using iNO in the initial resuscitation period as part of the de-implementation strategy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including ECLS use and/or mortality until hospital discharge
Treatment Details
Interventions
- De-implementation of Inhaled Nitric Oxide (iNO) use
- Inhaled Nitric Oxide (iNO)
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center, Houston
Lead Sponsor