A MRI Study of Visual and Motor Pathways in Premature Infants

This study is currently recruiting participants.
Verified February 2014 by Arkansas Children's Hospital Research Institute
Sponsor:
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01514747
First received: January 18, 2012
Last updated: February 11, 2014
Last verified: February 2014

January 18, 2012
February 11, 2014
October 2011
August 2014   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01514747 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A MRI Study of Visual and Motor Pathways in Premature Infants
Not Provided

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.

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

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

Premature Birth
Not Provided
ELBW infants
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
June 2015
August 2014   (final data collection date for primary outcome measure)

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
Both
2 Months to 5 Months
No
Not Provided
United States
 
NCT01514747
ISMRM_OU, ISMRM_2011
No
Arkansas Children's Hospital Research Institute
Arkansas Children's Hospital Research Institute
Not Provided
Not Provided
Arkansas Children's Hospital Research Institute
February 2014

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