Brain Structure and Development in Pre-Term and Full-Term Infants

Completed

• Conditions: Healthy

• Registration Number: NCT00679471
• Lead Sponsor: Christiana Care Health Services

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-05-14
• Study First Submitted QC: 2008-05-15
• Study First Posted: 2008-05-16
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-03
• Last Update Posted: 2013-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Name	Time	Method
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	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.

Trial Locations

Locations (2)

University of Delaware: Infant Motor Beahvior Lab; 🇺🇸 Newark, Delaware, United States

Christiana Hospital; 🇺🇸 Newark, Delaware, United States