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NCT00392977 · ClinicalTrials.gov registry record
Brain Manganese Deposition in High Risk Neonates
A clinical trial, sponsored by Vanderbilt University.
- Completed
- Registry status
- 43
- Enrollment target
NCT00392977: Completed study, sponsored by Vanderbilt University.
NCT00392977 is a clinical trial that has completed, run by Vanderbilt University. The registered enrollment target is 43 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00392977 has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- 43 participants
- Enrollment target
Study 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.
Interventions
- DIETARY_SUPPLEMENT remove Mn from PN if evidence of increased brain Mn on MRI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2006-08 |
| Est. Completion | 2010-12 |
What the finished NCT00392977 record still lists
NCT00392977 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 43 participants, a relatively small participant target.
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.
NCT00392977 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00392977 about?
NCT00392977 is a clinical study titled "Brain Manganese Deposition in High Risk Neonates". 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 investiga...
What is the current status of trial NCT00392977?
This trial is currently completed. The enrollment target is 43 participants. The study started on 2006-08. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00392977?
The interventions under investigation include: remove Mn from PN if evidence of increased brain Mn on MRI (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00392977?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
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