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Clinical Trials/NCT00679471
NCT00679471
Completed
N/A

The Relationship Between Early Brain Structure and Development in Full-Term and Pre-Term Infants

Christiana Care Health Services2 sites in 1 country47 target enrollmentNovember 2007
ConditionsHealthy

Overview

Phase
N/A
Intervention
Not specified
Conditions
Healthy
Sponsor
Christiana Care Health Services
Enrollment
47
Locations
2
Primary Endpoint
To compare the learning and coordination impairments of extremely low birth weight infants with full term infants at 3 and 6 months of age
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

The purpose of this study is to see how full-term and pre-term infants' brains relate to their movement and development throughout the first two years of life. All infants who participate in this study will have a magnetic resonance image (MRI) of the brain prior to discharge from the hospital. Infants will then have follow-up appointments every 3-6 months at home or at the Infant Motor Behavior Laboratory at the University of Delaware. The follow-up sessions will test how infants change their movements to respond to interesting objects or sounds in their environment. It is hoped that the results of this study will assist clinicians in developing better testing and treatment methods for those infants at risk for developmental problems.

Registry
clinicaltrials.gov
Start Date
November 2007
End Date
December 2011
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Pre-term infants (\< 1 Kg Birthweight)
  • Full-term infants (well)

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

To compare the learning and coordination impairments of extremely low birth weight infants with full term infants at 3 and 6 months of age

Time Frame: 6 months

To compare the learning and coordination impairments of extremely low birth weight infants with full term infants at 3 and 6 months of age. This is accomplished through a series of play activities.

Secondary Outcomes

  • To relate the learning and coordination impairments of extremely low birth weight infants at 3 and 6 months of age to their CNS impairments at term age.(6 months)

Study Sites (2)

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