Improving Motor Skill Development in Infants After Cardiac Surgery

NCT ID: NCT02700646

Last Updated: 2019-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-05

Study Completion Date

2019-05-13

Brief Summary

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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

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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.

Conditions

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Congenital Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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standard care

Standard care comparison

Group Type NO_INTERVENTION

No interventions assigned to this group

inpatient

Inpatient recommendations to parents regarding infant motor activities

Group Type EXPERIMENTAL

Developmental recommendations

Intervention Type BEHAVIORAL

Standard care

Intervention Type BEHAVIORAL

standard care

inpatient/outpatient

Inpatient and outpatient recommendations to parents regarding infant motor activities

Group Type EXPERIMENTAL

Developmental recommendations

Intervention Type BEHAVIORAL

Standard care

Intervention Type BEHAVIORAL

standard care

Interventions

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Developmental recommendations

Intervention Type BEHAVIORAL

Standard care

standard care

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Maximum Eligible Age

120 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Karen Uzark

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen Uzark, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00107611

Identifier Type: -

Identifier Source: org_study_id

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