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Clinical Trials/NCT01514747
NCT01514747CompletedNot Applicable

A MRI Study of Visual and Motor Pathways in Premature Infants

Arkansas Children's Hospital Research Institute1 site in 1 country40 target enrollmentStarted: October 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
MRI

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
2 Months to 5 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

MRI

Time Frame: 0

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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