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OpenTrials
Completed

NCT Number: NCT02700646

Improving Motor Skill Development in Infants After Cardiac Surgery

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.

Completed

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

Up to 120 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Developmental recommendations

Behavioral

Standard Care

Behavioral

standard care

Primary outcomes

  1. Gross Motor Scale score

    Time frame: 3 months after hospital discharge

    Alberta Infant Motor Scale (AIMS) score

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Acronym: DAISY

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 7, 2016
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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