Children Clinical Trial
Official title:
Physical Activity and Cognitive Development in Children
NCT number | NCT02542683 |
Other study ID # | AAAP7626 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 2016 |
Est. completion date | December 2028 |
1. Compare physical activity and cognitive functions between children having cardiac surgery with an age-matched group of children undergoing non-cardiac surgery, as well as otherwise healthy siblings or best buddies (or age and gender-matched children if no siblings or best buddies available) before surgery and after surgery or six months following initial assessment. 2. Determine the effects of a structured physical activity program for 6 months following surgery on cognitive functions and adaptive behavior in children following congenital cardiac surgery. 3. Determine the effects of a structured physical activity program for 12 months following surgery on cognitive functions and adaptive behavior in children following congenital cardiac surgery. 4. We will perform exploratory analysis to determine whether any effects of a 12-months structured physical activity program on cognitive functions and adaptive behavior persist beyond 12 months after cessation of the program.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 2028 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Months to 6 Years |
Eligibility | Inclusion Criteria: - Congenital Heart Diseases (CHD) Cohort: All children with congenital cyanotic cardiac diseases scheduled for congenital cardiac surgery who are older than 30 months of age. - Non-CHD, Surgical Cohort: All children 30 months or older who are undergoing non-cardiac surgery at Columbia University Medical Center (CUMC), including pediatric general surgery, urological surgery, ear, nose and throat (ENT) surgery, plastic surgery and eye surgery. These children will be recruited before surgery. - Non-surgical cohort: 1. Sibling of children of CHD patients within 12 months in age, and 30 months of age or older. 2. Relatives of CHD patients of the same gender within 12 months in age and 30 months of age or older. 3. Best buddies of CHD children within 12 months in age and 30 months of age or older. 4. Children who are matched by age ±6 months who are 30 months of age or older, gender, level parental education and language spoken at home Exclusion Criteria: 1. Children with known chromosomal syndromes, or known syndromes including but not limited to DiGeorge, Trisomy 21, WIlliams, Noonan and Turner. 2. Children with known physical disabilities. 3. Children with known history of central nervous system (CNS) injury including stroke, birth asphyxia, seizure disorder, intraventricular hemorrhage. 4. Children with abnormal neurological exam by a pediatric physician or nurse practitioner, and confirmed by a pediatric neurologist. 5. Children with tricuspid regurgitation on echocardiography or on cardiac angiography that is moderate or greater. 6. Children with moderate or greater decrease in ventricular function on echocardiography or on cardiac angiography. 7. Children with baseline room air oxygen saturation below 80%. 8. Children who are treated for dysrhythmias or are pacemaker-dependent. 9. Children with history of prematurity. (Non-surgical cohort) 10. Children with history of more than one episode of hospitalization. (Non-surgical cohort) |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Irving Medical Center / NewYork-Presbyterian Hospital | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intelligence Quotient (IQ) score | Global neurocognitive function assessment with IQ score using the Wechsler Preschool and Primary Scale of Intelligence (WPPSI 4): at baseline and up to 24 months later. | Up to 24 months from the time of assessment at baseline | |
Primary | Score on the NIH Toolbox Early Childhood Battery | Domain-specific neurocognitive function: Memory, learning, attention, executive function, language and motor function using the NIH Toolbox Early Childhood. Scores from each domain in the battery will be used . Domain-specific scores obtained at baseline, then every 6 months up to 24 months later. | Up to 24 months from the time of assessment at baseline | |
Primary | Score on Adaptive Behavior Assessment System, 3rd edition (ABAS-III) | Adaptive behavior: Parental reports of behavior using ABAS-III, collected at baseline and then every 6 months up to 24 months later. | Up to 24 months from the time of assessment at baseline | |
Secondary | Weight | Record weight and plot on growth curve at baseline, then every 6 months for 18 months. | Up to 24 months from baseline | |
Secondary | Height | Record height and plot on growth curve at baseline, then every 6 months for 18 months. | Up to 24 months from baseline |
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