Brain Manganese Deposition in High Risk Neonates

Completed

Conditions studied: Necrotizing Enterocolitis, Digestive System Abnormalities, Cholestasis

In brief

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.

Key facts

Study ID

NCT00392977

Run by

Vanderbilt University

People needed

43

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 1. Sex: any. Healthy volunteers: not 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.

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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