Observational study on congenital diaphragmatic hernia in newborns and children
ECHO-CDH - Exploratory Observational Prospective Study in Neonatal and Pediatric Congenital Diaphragmatic Hernia
McGill University Health Centre/Research Institute of the McGill University Health Centre · NCT04114578
This study looks at how congenital diaphragmatic hernia affects the heart and lungs in newborns and children to see if they face ongoing health challenges as they grow up.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre (other) |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT04114578 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the cardiac performance and pulmonary pressures in newborns and children with congenital diaphragmatic hernia (CDH). It will utilize advanced echocardiography techniques to assess left ventricular size and function, as well as pulmonary pressures, at various pediatric ages. The study will recruit CDH patients from the neonatal intensive care unit and follow-up clinics, synchronizing with existing follow-up programs for feasibility. The hypothesis is that CDH patients may continue to experience cardiac and pulmonary issues as they grow, which could lead to higher morbidity and altered neurodevelopmental outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are newborns and children diagnosed with congenital diaphragmatic hernia who are either admitted to the NICU or followed in the outpatient clinic.
Not a fit: Patients who are premature (less than 36 weeks), diagnosed after 7 days of life, have bilateral CDH, or have significant congenital cardiac defects or genetic syndromes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of cardiac and pulmonary complications in CDH patients, potentially enhancing their long-term health outcomes.
How similar studies have performed: While this study employs novel echocardiography techniques, similar studies have shown that understanding cardiac performance in CDH patients can lead to better management strategies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Montreal, Quebec
- Mcgill University Health Centre — Montreal, Quebec, Canada (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Congenital Diaphragmatic Hernia