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A MRI Study of Visual and Motor Pathways in Premature Infants

NCT ID: NCT01514747

Last Updated: 2019-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2018-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Premature Birth

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ELBW infants

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

2 Months

Maximum Eligible Age

5 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arkansas Children's Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Arkansas Children's Hospital

Little Rock, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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ISMRM_2011

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ISMRM_OU

Identifier Type: -

Identifier Source: org_study_id

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