Actively Recruiting
ECHO-CDH - Observational Study of Heart and Lung Function in Neonatal and Pediatric Congenital Diaphragmatic Hernia
Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2024-11-22
80
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Congenital Diaphragmatic Hernia (CDH) is linked to lung underdevelopment, high blood pressure in the lungs, and reduced size of the left heart ventricle. Researchers are studying how these heart and lung issues persist from newborn through pediatric and adolescent stages. They aim to understand how decreased heart function and increased lung pressure relate to other health problems and developmental challenges in children with CDH. This observational study uses advanced heart ultrasound techniques called echocardiography to assess heart function and lung pressure at multiple ages, from birth to adolescence. Several groups of patients at different ages will be studied, including newborns, infants, children, and pre-adolescents or adolescents. Data collection includes detailed heart measurements and developmental questionnaires. A comparison group without CDH will also be included. Participants will undergo scheduled echocardiograms at specific times, such as within 24 hours of birth, days 3 to 5, weeks 2 to 3, and at ages 4, 9 months, 3, 5, 8, 11, 14, and 17 years. Researchers will review medical records for perinatal and health information and collect developmental scores. Safety is monitored by alerting clinicians if significant anomalies are found during echocardiograms. The study will measure heart function and pulmonary hypertension over time to better understand CDH impacts.
CONDITIONS
Brief Title
Exploratory Observational Prospective Study in Neonatal and Pediatric Congenital Diaphragmatic Hernia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with congenital diaphragmatic hernia (CDH)
- Admitted to the MCH neonatal intensive care unit (NICU) or followed at the MCH CDH clinic
- Age from birth up to 17 years
You will not qualify if you...
- Born prematurely before 36 weeks of gestation
- CDH diagnosis made after 7 days of life
- Bilateral congenital diaphragmatic hernia
- Presence of congenital heart defects other than patent ductus arteriosus (PDA), atrial septal defect (ASD), or ventricular septal defect (VSD)
- Any major anomaly or genetic syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - From birth up to 17 years depending on age group
Participants undergo echocardiography assessments at various neonatal and pediatric ages to evaluate heart and lung function and developmental status.
Several echocardiography visits depending on age group, including neonatal visits within 24 hours, day 3-5, and 2-3 weeks of life, and follow-up visits at 4 and/or 9 months, 3, 5 and/or 8 years, and 11, 14 and/or 17 years
Duration - Up to 17 years
Participants are observed through developmental assessments and questionnaires to monitor neurodevelopmental profile and quality of life over time.
Age and stage questionnaires, CAT/CLAMS assessments, and Pediatric Quality of Life inventory surveys completed at scheduled visits corresponding to participant age
Trial Site Locations
Total: 1 location
1
Mcgill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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