CLINICAL TRIAL

Treatment for Hernia, Diaphragmatic

Waitlist Available · < 18 · All Sexes · Houston, TX

Inhaled Nitric Oxide (iNO) for Congenital Diaphragmatic Hernia (CDH) - The "NoNO Trial" - a Multi-center, De-implementation, Stepped-wedge, Cluster-randomized Trial Within an Established Collaborative

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About the trial for Hernia, Diaphragmatic

Eligible Conditions
Hernia, Diaphragmatic · Hernia · Hernias, Diaphragmatic, Congenital

Treatment Groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Control Group 1
De-implementation of Inhaled Nitric Oxide (iNO) use
OTHER
Control Group 2
Inhaled Nitric Oxide (iNO) use
DRUG

Eligibility

This trial is for patients born any sex aged 18 and younger. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Postnatal, live born neonates with CDH
a. Presence of associated or additional anomalies is acceptable for inclusion
Bochdalek hernia location (right or left)
Diagnosed prior to 1 month of life
You are born within or transferred to (within 1 week of life) a CDHSG member center participating in the trial. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: from birth through hospital discharge (upto 12 months from birth)
Screening: ~3 weeks
Treatment: Varies
Reporting: from birth through hospital discharge (upto 12 months from birth)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: from birth through hospital discharge (upto 12 months from birth).
View detailed reporting requirements
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- What options you have available- The pros & cons of this trial
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Measurement Requirements

This trial is evaluating whether Treatment will improve 1 primary outcome and 4 secondary outcomes in patients with Hernia, Diaphragmatic. Measurement will happen over the course of 6 hours after initiation of iNO use.

Change in oxygenation
6 HOURS AFTER INITIATION OF INO USE
For the iNO de-implementation arm, participants will be assessed 6 hours after the time when iNO would have been initiated, per the protocol of the center.
6 HOURS AFTER INITIATION OF INO USE
Number of participants that require Extracorporeal Life Support (ECLS) prior to discharge
FROM BIRTH THROUGH HOSPITAL DISCHARGE (UPTO 12 MONTHS FROM BIRTH)
FROM BIRTH THROUGH HOSPITAL DISCHARGE (UPTO 12 MONTHS FROM BIRTH)
Number of participants that die prior to discharge
FROM BIRTH THROUGH HOSPITAL DISCHARGE (UPTO 12 MONTHS FROM BIRTH)
FROM BIRTH THROUGH HOSPITAL DISCHARGE (UPTO 12 MONTHS FROM BIRTH)
Total cost of initial inpatient care from birth through hospital discharge, per center
FROM BIRTH THROUGH HOSPITAL DISCHARGE (UPTO 12 MONTHS FROM BIRTH)
FROM BIRTH THROUGH HOSPITAL DISCHARGE (UPTO 12 MONTHS FROM BIRTH)
Number of participants that require Extracorporeal Life Support (ECLS) and/or that die prior to discharge
FROM BIRTH THROUGH HOSPITAL DISCHARGE (UPTO 12 MONTHS FROM BIRTH)
The primary outcome is the composite outcome of ECLS use and/or mortality.
FROM BIRTH THROUGH HOSPITAL DISCHARGE (UPTO 12 MONTHS FROM BIRTH)

Who is running the study

Principal Investigator
M. T. H.
Prof. Matthew Tihen Harting, Associate Professor
The University of Texas Health Science Center, Houston

Patient Q & A Section

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Other questions from users

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Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Hernia, Diaphragmatic by sharing your contact details with the study coordinator.