Improving Motor Skill Development in Infants After Cardiac Surgery

Study Overview
=================
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.

Official Title
-----------------
Improving Motor Skill Development in Infants After Cardiac Surgery

Conditions
-----------------
Congenital Heart Disease

Intervention / Treatment
-----------------
* Behavioral: Developmental recommendations
* Behavioral: Standard care


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Maximum Age: 120 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard care<br>Standard care comparison | |
| Experimental: inpatient<br>Inpatient recommendations to parents regarding infant motor activities | Behavioral: Developmental recommendations<br> <br> Behavioral: Standard care<br>* standard care<br>|
| Experimental: inpatient/outpatient<br>Inpatient and outpatient recommendations to parents regarding infant motor activities | Behavioral: Developmental recommendations<br> <br> Behavioral: Standard care<br>* standard care<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gross Motor Scale score | Alberta Infant Motor Scale (AIMS) score | 3 months after hospital discharge |