Status:
COMPLETED
Brain Manganese Deposition in High Risk Neonates
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
National Institute of Environmental Health Sciences (NIEHS)
Conditions:
Necrotizing Enterocolitis
Digestive System Abnormalities
Eligibility:
All Genders
30-12 years
Brief Summary
Excessive exposure to manganese (Mn) results in Mn deposition in the brain causing adverse neurological effects. Sick infants requiring parenteral nutrition (PN) may be at increased risk of Mn neuroto...
Detailed Description
Manganese (Mn) is an essential metal needed for normal growth and development. Excessive environmental or dietary exposure results in Mn deposition in Mn-sensitive brain regions causing adverse psycho...
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.
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 :
43 Patients enrolled
Trial Details
Trial ID
NCT00392977
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