NCT02700646

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 7, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2019

Completed
Last Updated

August 6, 2019

Status Verified

August 1, 2019

Enrollment Period

3.4 years

First QC Date

March 2, 2016

Last Update Submit

August 5, 2019

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Gross Motor Scale score

    Alberta Infant Motor Scale (AIMS) score

    3 months after hospital discharge

Study Arms (3)

standard care

NO INTERVENTION

Standard care comparison

inpatient

EXPERIMENTAL

Inpatient recommendations to parents regarding infant motor activities

Behavioral: Developmental recommendationsBehavioral: Standard care

inpatient/outpatient

EXPERIMENTAL

Inpatient and outpatient recommendations to parents regarding infant motor activities

Behavioral: Developmental recommendationsBehavioral: Standard care

Interventions

Developmental recommendationsBEHAVIORAL
inpatientinpatient/outpatient
Standard careBEHAVIORAL

standard care

inpatientinpatient/outpatient

Eligibility Criteria

AgeUp to 120 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All hospitalized infants under age 4 months having cardiac surgery before age 3 months
  • Intubation \>/= 24 hours \</= 14 days

You may not qualify if:

  • Prematurity \</= 36 weeks gestation
  • Pre-operative clinical evidence of a central nervous system (CNS) anomaly or history of CNS insult

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Karen Uzark, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Cardiac Surgery and Associate Professor of Pediatric Cardiology, Medical School

Study Record Dates

First Submitted

March 2, 2016

First Posted

March 7, 2016

Study Start

January 5, 2016

Primary Completion

May 13, 2019

Study Completion

May 13, 2019

Last Updated

August 6, 2019

Record last verified: 2019-08

Locations

US(1)