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NCT01514747 Clinical Trial

A MRI Study of Visual and Motor Pathways in Premature Infants

Premature Birth Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01514747
Other study ID # ISMRM_OU
Secondary ID ISMRM_2011
Status Completed
Phase
First received
Last updated
Start date October 2011
Est. completion date August 2018

Study information
Verified date July 2019
Source Arkansas Children's Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date August 2018
Est. primary completion date August 2018
Accepts healthy volunteers No
Gender All
Age group 2 Months to 5 Months
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Arkansas Children's Hospital Little Rock Arkansas

Sponsors (1)
Lead Sponsor Collaborator
Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary MRI 0
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