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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

May 14, 2008
June 3, 2013
November 2007
December 2011   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00679471 on ClinicalTrials.gov Archive Site
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.
Not Provided
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.
Not Provided
 
Brain Structure and Development in Pre-Term and Full-Term Infants
The Relationship Between Early Brain Structure and Development in Full-Term and Pre-Term Infants

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Healthy
Not Provided
  • Pre-Term
    Infants born pre-term with birthweight less than 1KG
  • Full-Term Infants
    Well infants who are born full-term
Gadin E, Lobo M, Paul DA, Sem K, Steiner KV, Mackley A, Anzilotti K, Galloway C. Volumetric MRI and MRS and early motor development of infants born preterm. Pediatr Phys Ther. 2012 Spring;24(1):38-44. doi: 10.1097/PEP.0b013e31823e069d.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pre-term infants (< 1 Kg Birthweight)
  • Full-term infants (well)
Both
up to 30 Months
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00679471
CCC27122
No
Christiana Care Health Services
Christiana Care Health Services
University of Delaware
Principal Investigator: David A. Paul, MD Christiana Hospital
Christiana Care Health Services
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP