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

This study has been completed.
Sponsor:
Collaborator:
University of Delaware
Information provided by (Responsible Party):
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00679471
First received: May 14, 2008
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

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.


Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Relationship Between Early Brain Structure and Development in Full-Term and Pre-Term Infants

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Christiana Care Health Services:

Primary Outcome 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • To determine the ability of data from learning and coordination impairments and brain MRI / MRS (magnetic resonance spectroscopy) to predict results from common clinical assessments from 3-24 months. [ Time Frame: 24 months. ] [ Designated as safety issue: No ]
    To determine the ability of data from learning and coordination impairments and brain MRI / MRS (magnetic resonance spectroscopy) to predict results from common clinical assessments from 3-24 months. MRI / MRS (magnetic resonance spectroscopy) of the brain was performed as close to term equivalent age as possible.


Enrollment: 47
Study Start Date: November 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pre-Term
Infants born pre-term with birthweight less than 1KG
Full-Term Infants
Well infants who are born full-term

  Eligibility

Ages Eligible for Study:   up to 30 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pre-term or full-term infants who are admitted to the Neonatal Intensive Care Unit (NICU) at Christiana Hospital.

Criteria

Inclusion Criteria:

  • Pre-term infants (< 1 Kg Birthweight)
  • Full-term infants (well)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00679471

Locations
United States, Delaware
Christiana Hospital
Newark, Delaware, United States, 19718
University of Delaware: Infant Motor Beahvior Lab
Newark, Delaware, United States, 19717
Sponsors and Collaborators
Christiana Care Health Services
University of Delaware
Investigators
Principal Investigator: David A. Paul, MD Christiana Hospital
  More Information

No publications provided by Christiana Care Health Services

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT00679471     History of Changes
Other Study ID Numbers: CCC27122
Study First Received: May 14, 2008
Last Updated: June 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:
pre-term infants
full-term infants
MRI
 brain structure development
pre term
full term

ClinicalTrials.gov processed this record on June 17, 2013