Improving Motor Skill Development in Infants After Cardiac Surgery

Last updated: August 5, 2019
Sponsor: University of Michigan
Overall Status: Completed

Phase

N/A

Condition

Pentalogy Of Cantrell

Heart Disease

Congenital Heart Disease

Treatment

N/A

Clinical Study ID

NCT02700646
HUM00107611
  • Ages < 120
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All hospitalized infants under age 4 months having cardiac surgery before age 3 months

  • Intubation >/= 24 hours </= 14 days

Exclusion

Exclusion Criteria:

  • Prematurity </= 36 weeks gestation

  • Pre-operative clinical evidence of a central nervous system (CNS) anomaly or historyof CNS insult

Study Design

Total Participants: 65
Study Start date:
January 05, 2016
Estimated Completion Date:
May 13, 2019

Study 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.

Connect with a study center

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

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