Improving Motor Skill Development in Infants After Cardiac Surgery (DAISY)

August 5, 2019 updated by: Karen Uzark, University of Michigan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: standard care
Standard care comparison
Experimental: inpatient
Inpatient recommendations to parents regarding infant motor activities
Behavioral: Standard care
standard care
Behavioral: Developmental recommendations
Experimental: inpatient/outpatient
Inpatient and outpatient recommendations to parents regarding infant motor activities
Behavioral: Standard care
standard care
Behavioral: Developmental recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gross Motor Scale score
Time Frame: 3 months after hospital discharge
Alberta Infant Motor Scale (AIMS) score
3 months after hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Karen Uzark, PhD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2016

Primary Completion (Actual)

May 13, 2019

Study Completion (Actual)

May 13, 2019

Study Registration Dates

First Submitted

March 2, 2016

First Submitted That Met QC Criteria

March 2, 2016

First Posted (Estimate)

March 7, 2016

Study Record Updates

Last Update Posted (Actual)

August 6, 2019

Last Update Submitted That Met QC Criteria

August 5, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00107611

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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