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NCT00392730 · ClinicalTrials.gov registry record
Neurodevelopment and Neuroimaging in Parenterally-fed Infants and Young Children
A clinical trial, sponsored by Vanderbilt University.
- Completed
- Registry status
- 122
- Enrollment target
NCT00392730: Completed study, sponsored by Vanderbilt University.
NCT00392730 is a clinical trial that has completed, run by Vanderbilt University. The registered enrollment target is 122 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00392730 has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- 122 participants
- Enrollment target
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.
Primary Outcome
Mn neurotoxicity will be investigated by magnetic resonance (MR) relaxometry in a population of infants receiving Mn-supplemented parenteral nutrition and age-matched controls.
Interventions
- DIETARY_SUPPLEMENT Remove Mn from PN if evidence of increased brain Mn on MRI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2006-08 |
| Est. Completion | 2010-12 |
What the finished NCT00392730 record still lists
NCT00392730 is an observational study that tracks outcomes without assigning an intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Remove Mn from PN if evidence of increased brain Mn on MRI is the first listed.
NCT00392730 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00392730 about?
NCT00392730 is a clinical study titled "Neurodevelopment and Neuroimaging in Parenterally-fed Infants and Young Children". 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 alte...
What is the current status of trial NCT00392730?
This trial is currently completed. The enrollment target is 122 participants. The study started on 2006-08. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00392730?
The interventions under investigation include: Remove Mn from PN if evidence of increased brain Mn on MRI (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00392730?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
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