Observational study on congenital diaphragmatic hernia in newborns and children
Official title: ECHO-CDH - Exploratory Observational Prospective Study in Neonatal and Pediatric Congenital Diaphragmatic Hernia
Run by McGill University Health Centre/Research Institute of the McGill University Health Centre · NCT04114578 · Data updated 2026-11-12
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 |
|---|---|
| Ages | Any age to 17 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Status | Recruiting |
| Started | October 1, 2019 |
| Main results expected | December 31, 2023 |
| Study ends | June 30, 2025 |
| Registry record updated | November 22, 2024 |
| Trial ID | NCT04114578 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this study employs novel echocardiography techniques, similar studies have shown that understanding cardiac performance in CDH patients can lead to better management strategies.
Who can join: the full rules
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 it's running
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Mcgill University Health Centre
Montreal, Quebec, Canada Recruiting
Similar studies
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This trial will test whether performing FETO in fetuses with isolated severe left or right CDH helps more babies survive to hospital discharge and have fewer long-term problems than standard care.
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This study is testing a new way to treat congenital diaphragmatic hernia in unborn babies by placing a balloon in their airway to help their lungs grow before they are born.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.