Exploratory Observational Prospective Study in Neonatal and Pediatric Congenital Diaphragmatic He… (NCT04114578) | Clinical Trial Compass
RecruitingNot Applicable
Exploratory Observational Prospective Study in Neonatal and Pediatric Congenital Diaphragmatic Hernia
Canada80 participantsStarted 2019-10-01
Plain-language summary
CDH is associated with lung hypoplasia, pulmonary hypertension, and left ventricular hypoplasia.
Use of new STE techniques (heart ultrasound) showed that CDH newborns have decreased LV size and function, potentially explaining the non-response to iNO, and that these cardiac findings were associated with poor outcomes. Our hypothesis: CDH newborns persist to have some degree of LV hypoplasia in the pediatric and adolescent life and pulmonary pressures remain increased during growth. Patients with decreased cardiac performance by STE and/or with PH have higher concomitant neonatal or pediatric morbidities and altered neurodevelopmental profile
Who can participate
Age range
17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion:
* CDH patients admitted to the MCH-NICU
* CDH followed at the MCH CDH clinic
Exclusion:
* Prematurity (\< 36 weeks)
* Diagnosis at \> 7 days of life
* Bilateral CDH
* Congenital cardiac defect (excluding a patent ductus arteriosus (PDA), atrial septal defect (ASD) or ventricular septal defect (VSD)) and/or other major anomaly/genetic syndrome.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of cardiac function
Timeframe: Within 24 hours of life
2
Assessment of cardiac function
Timeframe: Between day 3 to 5 of life
3
Assessment of cardiac function
Timeframe: Between 2 to 3 weeks of life
4
Assessment of cardiac function
Timeframe: age of 4 and/or 9 months
5
Assessment of cardiac function
Timeframe: 3, 5 and/or 8 years
6
Assessment of cardiac function
Timeframe: 11, 14 and/or 17 years
Trial details
NCT IDNCT04114578
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre