NCT04114578 Exploratory Observational Prospective Study in Neonatal and Pediatric Congenital Diaphragmatic Hernia
| NCT ID | NCT04114578 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre |
| Condition | Congenital Diaphragmatic Hernia |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2019-10-01 |
| Primary Completion | 2023-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2019-10-01 with a primary completion date of 2023-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT04114578 clinical trial?
This trial is open to participants of all sexes, up to 17 Years, studying Congenital Diaphragmatic Hernia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04114578 currently recruiting?
Yes, NCT04114578 is actively recruiting participants. Visit ClinicalTrials.gov or contact McGill University Health Centre/Research Institute of the McGill University Health Centre to inquire about joining.
Where is the NCT04114578 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT04114578 clinical trial?
NCT04114578 is sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. The trial plans to enroll 80 participants.