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A MRI Study of Visual and Motor Pathways in Premature Infants

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01514747
First received: January 18, 2012
Last updated: January 13, 2015
Last verified: January 2015
  Purpose

Approximately 30,000 babies annually are born with extremely low birth weight (ELBW) in the US. These babies often have motor and/or visual problems when they grow up. It is very important to identify high risk ELBW infants as early as possible, so that the investigators can treat them earlier to prevent poor development. Neurological examination at early age is not good enough to identify high risk ELBW infants. One the other hand, some magnetic resonance imaging (MRI) methods such as diffusion tensor imaging (DTI) and resting state functional MRI (rfMRI) have shown great sensitivity to brain injury which may cause motor and visual problems. Therefore, the investigators propose to use DTI and rfMRI on ELBW infants at a very early age to predict long−term outcome and to identify infants who are at high risk of having motor and/or visual problems when they grow up.


Condition
Premature Birth

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Arkansas Children's Hospital Research Institute:

Primary Outcome Measures:
  • MRI [ Time Frame: 0 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2011
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
ELBW infants

  Eligibility

Ages Eligible for Study:   2 Months to 5 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

ELBW infants with birth weight 401-1000 g (gestational age <30 weeks)

Criteria

Inclusion Criteria:

  • ELBW infants with birth weight 401-1000 g (gestational age <30 weeks)

Exclusion Criteria:

  • Complex congenital anomalies
  • Central nervous system malformations,
  • Chromosomal abnormalities, or hydrops fetalis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514747

Locations
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72211
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
  More Information

No publications provided

Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01514747     History of Changes
Other Study ID Numbers: ISMRM_OU, ISMRM_2011
Study First Received: January 18, 2012
Last Updated: January 13, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on February 27, 2015