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Clinical Trials/NCT02700646
NCT02700646
Completed
N/A

Improving Motor Skill Development in Infants After Cardiac Surgery

University of Michigan1 site in 1 country65 target enrollmentJanuary 5, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Congenital Heart Disease
Sponsor
University of Michigan
Enrollment
65
Locations
1
Primary Endpoint
Gross Motor Scale score
Status
Completed
Last Updated
6 years ago

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.

Registry
clinicaltrials.gov
Start Date
January 5, 2016
End Date
May 13, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Karen Uzark

Professor of Cardiac Surgery and Associate Professor of Pediatric Cardiology, Medical School

University of Michigan

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

Outcomes

Primary Outcomes

Gross Motor Scale score

Time Frame: 3 months after hospital discharge

Alberta Infant Motor Scale (AIMS) score

Study Sites (1)

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