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Sponsors and Collaborators: |
Christiana Care Health Services University of Delaware: Department of Physical Therapy University of Delaware |
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Information provided by: | Christiana Care Health Services |
ClinicalTrials.gov Identifier: | NCT00679471 |
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 |
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Healthy |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | The Relationship Between Early Brain Structure and Development in Full-Term and Pre-Term Infants |
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 |
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Pre-Term
Infants born pre-term with birthweight less than 1KG
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Full-Term Infants
Well infants who are born full-term
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Ages Eligible for Study: | up to 8 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Pre-term or full-term infants who are admitted to the Neonatal Intensive Care Unit (NICU) at Christiana Hospital.
Inclusion Criteria:
Contact: Amy B. Mackley, MSN | 302-733-2153 | amackley@christianacare.org |
Contact: James (Cole) C. Galloway, PhD, PT | 302-831-3697 | jacgallo@udel.edu |
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 |
Principal Investigator: | David A. Paul, MD | Christiana Hospital |
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 |
pre-term infants full-term infants MRI |
brain structure development pre term full term |
Healthy |