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

Overview

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.

Full Title of Study: “The Relationship Between Early Brain Structure and Development in Full-Term and Pre-Term Infants”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2011

Arms, Groups and Cohorts

  • Pre-Term
    • Infants born pre-term with birthweight less than 1KG
  • Full-Term Infants
    • Well infants who are born full-term

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
    • Time Frame: 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.

Participating in This Clinical Trial

Inclusion Criteria

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 30 Months

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Christiana Care Health Services
  • Collaborator
    • University of Delaware
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • David A. Paul, MD, Principal Investigator, Christiana Hospital

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