Improving Motor Skill Development in Infants After Cardiac Surgery

Not Applicable

Completed

• Conditions: Congenital Heart Disease
• Interventions: Behavioral: Developmental recommendations; Behavioral: Standard care

• Registration Number: NCT02700646
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study Start: 2016-01-05
• Study First Submitted: 2016-03-02
• Study First Submitted QC: 2016-03-02
• Study First Posted: 2016-03-07
• Primary Completion: 2019-05-13
• Study Completion: 2019-05-13
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• All hospitalized infants under age 4 months having cardiac surgery before age 3 months
• Intubation >/= 24 hours </= 14 days

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Exclusion Criteria

• Prematurity </= 36 weeks gestation
• Pre-operative clinical evidence of a central nervous system (CNS) anomaly or history of CNS insult

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
inpatient/outpatient	Developmental recommendations	Inpatient and outpatient recommendations to parents regarding infant motor activities
inpatient	Standard care	Inpatient recommendations to parents regarding infant motor activities
inpatient/outpatient	Standard care	Inpatient and outpatient recommendations to parents regarding infant motor activities
inpatient	Developmental recommendations	Inpatient recommendations to parents regarding infant motor activities

Primary Outcome Measures

Name	Time	Method
Gross Motor Scale score	3 months after hospital discharge	Alberta Infant Motor Scale (AIMS) score

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States