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Brain Manganese Deposition in High Risk Neonates

NCT00392977 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 43

Last updated 2013-12-19

No results posted yet for this study

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 neurotoxicity because neonatal PN solutions contain high concentrations of Mn. This proposal will investigate brain deposition of Mn, a paramagnetic element, by magnetic resonance (MR) imaging in preterm and term neonates receiving Mn-supplemented PN and gestational age-matched control infants. The goals of this project are to identify neonatal populations that are at increased risk of excessive brain Mn deposition based on their gestational age, iron status, hepatic function and dietary Mn intake, and to make evidence-based recommendations for appropriate Mn supplementation and monitoring of infants receiving PN.

Conditions

  • Necrotizing Enterocolitis
  • Digestive System Abnormalities
  • Cholestasis

Interventions

DIETARY_SUPPLEMENT

remove Mn from PN if evidence of increased brain Mn on MRI

trace element cocktail will be withheld and zinc, copper and chromium added to PN individually.

Sponsors & Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)

    collaborator NIH

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Judy L Aschner, MD · Vanderbilt University Medical Center

Eligibility

Min Age
30 Days
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00392977 on ClinicalTrials.gov