Status:
COMPLETED
Neurodevelopment and Neuroimaging in Parenterally-fed Infants and Young Children
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
The Gerber Foundation
Conditions:
Parenteral Nutrition
Necrotizing Enterocolitis
Eligibility:
All Genders
30-6 years
Brief Summary
Manganese (Mn) is an essential metal required for normal growth and development. However, exposure to high Mn levels can be toxic to the brain. The objectives of this project are to identify neonatal ...
Detailed Description
Specific Aims have been designed to test these hypotheses in three developmentally distinct populations: 1. preterm infants and 2. full term infants in the Neonatal Intensive Care Unit (NICU) requiri...
Eligibility Criteria
Inclusion
- Greater than 30 days postnatal age
- In the preceding four weeks, have received \>75% of their nutrition as Mn-supplemented PN
- Clinically stable for transport to the MR facility
- Signed parental consent.
- Or healthy age-matched controls
Exclusion
- Any infant not expected to survive to the age of 3 months or
- Not expected to achieve sufficient clinical stability to tolerate the MRI procedure.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00392730
Start Date
August 1 2006
End Date
December 1 2010
Last Update
December 19 2013
Active Locations (1)
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1
Vanderbilt Children's Hospital
Nashville, Tennessee, United States, 37232-9544