Congenital Heart Disease
Conditions
Brief summary
The purpose of this study is to learn more about developmental behaviors and to examine changes in developmental progress related to motor activities among a group of infants who received open heart surgery within the first three months of life.
Detailed description
Congenital heart disease (CHD) and the need for life-saving heart surgery and intensive care during infancy may have effects on infant behavior and development. Children who require open heart surgery before their first birthday are vulnerable to developmental delays, especially related to motor skills (mobility) in the first year of life. Early delays in gross motor functioning (e.g., rolling, crawling, walking) have implications for learning and psychosocial development through adulthood. To date, no interventions to improve the gross motor functioning of children born with CHD have been developed. The purpose of this study is to learn more about developmental behaviors and to examine changes in developmental progress related to motor activities among a group of infants who received open heart surgery within the first three months of life. Activities will be tailored based on the individual infant's motor ability and medical status.
Interventions
BEHAVIORALDevelopmental recommendations
BEHAVIORALStandard care
standard care
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
No minimum to 120 Days
Healthy volunteers
No
Inclusion criteria
* All hospitalized infants under age 4 months having cardiac surgery before age 3 months * Intubation \>/= 24 hours \</= 14 days
Exclusion criteria
* Prematurity \</= 36 weeks gestation * Pre-operative clinical evidence of a central nervous system (CNS) anomaly or history of CNS insult
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gross Motor Scale score | 3 months after hospital discharge | Alberta Infant Motor Scale (AIMS) score |
Countries
United States
Outcome results
None listed