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: April 14, 2016
Last verified: April 2016

January 18, 2012
April 14, 2016
October 2011
August 2016   (final data collection date for primary outcome measure)
MRI [ Time Frame: 0 ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01514747 on ClinicalTrials.gov Archive Site
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A MRI Study of Visual and Motor Pathways in Premature Infants
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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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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
ELBW infants with birth weight 401-1000 g (gestational age <30 weeks)
Premature Birth
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ELBW infants
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
August 2016
August 2016   (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   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01514747
ISMRM_OU, ISMRM_2011
No
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Arkansas Children's Hospital Research Institute
Arkansas Children's Hospital Research Institute
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Arkansas Children's Hospital Research Institute
April 2016

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