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NCT02700646 Clinical Trial

Improving Motor Skill Development in Infants After Cardiac Surgery

Congenital Heart Disease Clinical Trial

— DAISY  

Official title:
Improving Motor Skill Development in Infants After Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02700646
Other study ID # HUM00107611
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 5, 2016
Est. completion date May 13, 2019

Study information
Verified date August 2019
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 65
Est. completion date May 13, 2019
Est. primary completion date May 13, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 120 Days
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Developmental recommendations

• Standard care
standard care

Locations
Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (1)
Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Gross Motor Scale score Alberta Infant Motor Scale (AIMS) score 3 months after hospital discharge
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