CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 43 enrolled
Drug / intervention
remove Mn from PN if evidence of increased brain Mn on MRIdietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00392977
NCT00392977N/ACompleted

Brain Manganese Deposition in High Risk Neonates

Vanderbilt University·observational·Posted Oct 26, 2006·Updated Dec 19, 2013

In Brief

An observational study evaluating remove Mn from PN if evidence of increased brain Mn on MRI for Necrotizing Enterocolitis and 2 related conditions. Completed, enrolled 43 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 26, 2006
Enrollment StartAug 1, 2006
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 19.7 years ago

Interventions

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

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