De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
This study is looking at whether stopping the use of inhaled nitric oxide (iNO) during the initial care of newborns with congenital diaphragmatic hernia (CDH) is effective. CDH is a birth defect where there's a hole in the diaphragm, the muscle that separates the chest from the abdomen. Researchers want to see if de-implementing iNO affects the need for extracorporeal life support (ECLS), a machine that acts as artificial heart and lungs, or the risk of death before leaving the hospital. They are also studying the cost-effectiveness of this approach. You might be able to join if you are a newborn (up to 1 month old) with CDH, including those with other health issues, and have a specific type of hernia called a Bochdalek hernia. The study aims to enroll 600 participants, but its current status is unclear.
- Study design
- This is a multi-center study where hospitals will first use iNO as usual, then switch to not using it. The timing of this switch will be randomly determined for each hospital.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed from birth through hospital discharge, up to 12 months from birth, to assess outcomes.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
At a glance
Conditions
Where it's being run
19 sites across 15 statesStudy leadership
- Matthew Harting, MD, MS, FACS · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Number of participants who require Extracorporeal Life Support (ECLS) and/or who die prior to dischargefrom birth through hospital discharge (up to 12 months from birth)
The primary outcome is the composite outcome of ECLS use and/or mortality.