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
See full descriptionAbout 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.
De-implementation of Inhaled Nitric Oxide (iNO) use
OTHER
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:View All
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
Odds of EligibilitySimilar Trials
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
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)
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like
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 USE6 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.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)FROM BIRTH THROUGH HOSPITAL DISCHARGE (UPTO 12 MONTHS FROM BIRTH)
The primary outcome is the composite outcome of ECLS use and/or mortality.Who is running the study
Principal InvestigatorM. 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
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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.