Neurodevelopment and Neuroimaging in Parenterally-fed Infants and Young Children

Completed

Conditions studied: Parenteral Nutrition, Necrotizing Enterocolitis, Digestive System Abnormalities, Cholestasis

In brief

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.

Key facts

Study ID: NCT00392730
Run by: Vanderbilt University
People needed: 122
Starts: 2006-08-01
Expected to finish: 2010-12-01
Last updated by the study team: 2013-12-19

Who can join

Age: 0 and older, up to 6. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Vanderbilt Children's Hospital — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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