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Neurodevelopment and Neuroimaging in Parenterally-fed Infants and Young Children

NCT00392730 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 122

Last updated 2013-12-19

No results posted yet for this study

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 and young pediatric populations that are at increased risk of excessive brain Mn deposition and altered cognitive and motor development based on their dietary parenteral Mn exposure, and to make sound and evidence-based recommendations for appropriate Mn supplementation and monitoring of infants and young children receiving parenteral nutrition (PN). Our studies are designed to test the hypotheses that, compared with unexposed age-matched controls, infants and young children receiving prolonged Mn-supplemented PN will have increased deposition of Mn in their brains and lower scores on neurodevelopmental, cognitive and psychophysiological assessments.

Conditions

  • Parenteral Nutrition
  • Necrotizing Enterocolitis
  • Digestive System Abnormalities
  • Cholestasis

Interventions

DIETARY_SUPPLEMENT

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

Withhold Mn-containing trace element cocktail and add zinc, copper and chromium individually to PN

Sponsors & Collaborators

  • The Gerber Foundation

    collaborator OTHER

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Judy L Aschner, MD · Vanderbilt University Medical Center

Eligibility

Min Age
30 Days
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

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 NCT00392730 on ClinicalTrials.gov