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Brain Structure and Development in Pre-Term and Full-Term Infants
This study is currently recruiting participants.
Verified by Christiana Care Health Services, September 2008
Sponsors and Collaborators: Christiana Care Health Services
University of Delaware: Department of Physical Therapy
University of Delaware
Information provided by: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT00679471
  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

U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: The Relationship Between Early Brain Structure and Development in Full-Term and Pre-Term Infants

Further study details as provided by Christiana Care Health Services:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 90
Study Start Date: November 2007
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2012 (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 8 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

Contacts
Contact: Amy B. Mackley, MSN 302-733-2153 amackley@christianacare.org
Contact: James (Cole) C. Galloway, PhD, PT 302-831-3697 jacgallo@udel.edu

Locations
United States, Delaware
Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Amy B. Mackley, MSN, RNC     302-733-2153     amackley@christianacare.org    
Contact: David A. Paul, MD     302-733-2410     dpaul@christianacare.org    
Sub-Investigator: Amy B. Mackley, MSN, RNC            
Sub-Investigator: Kert Anzilotti, MD            
Principal Investigator: David A. Paul, MD            
University of Delaware: Infant Motor Beahvior Lab Active, not recruiting
Newark, Delaware, United States, 19717
Sponsors and Collaborators
Christiana Care Health Services
University of Delaware: Department of Physical Therapy
University of Delaware
Investigators
Principal Investigator: David A. Paul, MD Christiana Hospital
  More Information

Responsible Party: University of Delaware ( James C. (Cole) Galloway, phD, PT )
Study ID Numbers: CCC27122
Study First Received: May 14, 2008
Last Updated: September 24, 2008
ClinicalTrials.gov Identifier: NCT00679471  
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

Study placed in the following topic categories:
Healthy

ClinicalTrials.gov processed this record on January 15, 2009