Back to resultsImproving Motor Skill Development in Infants After Cardiac Surgery (DAISY)
Primary Purpose
Congenital Heart Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Developmental recommendations
Standard care
Sponsored by
About this trial
This is an interventional other trial for Congenital Heart Disease
Eligibility Criteria
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
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
standard care
inpatient
inpatient/outpatient
Arm Description
Standard care comparison
Inpatient recommendations to parents regarding infant motor activities
Inpatient and outpatient recommendations to parents regarding infant motor activities
Outcomes
Primary Outcome Measures
Gross Motor Scale score
Alberta Infant Motor Scale (AIMS) score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02700646
Brief Title
Improving Motor Skill Development in Infants After Cardiac Surgery
Acronym
DAISY
Official Title
Improving Motor Skill Development in Infants After Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 5, 2016 (Actual)
Primary Completion Date
May 13, 2019 (Actual)
Study Completion Date
May 13, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
standard care
Arm Type
No Intervention
Arm Description
Standard care comparison
Arm Title
inpatient
Arm Type
Experimental
Arm Description
Inpatient recommendations to parents regarding infant motor activities
Arm Title
inpatient/outpatient
Arm Type
Experimental
Arm Description
Inpatient and outpatient recommendations to parents regarding infant motor activities
Intervention Type
Behavioral
Intervention Name(s)
Developmental recommendations
Intervention Type
Behavioral
Intervention Name(s)
Standard care
Intervention Description
standard care
Primary Outcome Measure Information:
Title
Gross Motor Scale score
Description
Alberta Infant Motor Scale (AIMS) score
Time Frame
3 months after hospital discharge
10. Eligibility
Sex
All
Maximum Age & Unit of Time
120 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Uzark, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Improving Motor Skill Development in Infants After Cardiac Surgery
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