Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00392730
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2006-10-25
Brief Title:
Neurodevelopment and Neuroimaging in Parenterally-fed Infants and Young Children
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
Official Title:
Neurodevelopment and Neuroimaging in Parenterally-fed Infants and Young Children
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Specific Aims have been designed to test these hypotheses in three developmentally distinct populations
1 preterm infants and
2 full term infants in the Neonatal Intensive Care Unit NICU requiring prolonged PN and
3 older infants and young children on home PN
Mn neurotoxicity will be investigated by longitudinal assessments of cognitive executive functioning battery neurodevelopmental Bayley III Scales of Infant Development and psychophysiological event-related potential measures and will be correlated with brain deposition of Mn using the technique of magnetic resonance MR relaxometry in a vulnerable population of infants receiving Mn-supplemented PN and age-matched controls This proposal addresses a clinically relevant and unexplored link between nutritional practices brain Mn deposition and neurodevelopmental sequelae in an at-risk population of infants and young children utilizing state-of-the-art magnetic resonance imaging MRI technology and neurodevelopmental assessment techniques The potential for increased brain Mn accumulation in infants and by inference the potential health risks associated with elevated brain Mn burden represents crucial unexplored issues of exposure and susceptibility The potential contribution of Mn toxicity to the poor outcomes of infants dependent for an extended time on PN has not been fully acknowledged or studied Improved understanding of the relationships between Mn exposure and developmental outcomes will undoubtedly lead to altered clinical practices and more careful monitoring of Mn intake and blood andor brain Mn levels in high risk infants Our studies will also contribute to an improved understanding of the value of non-invasive MR imaging in the monitoring of pediatric patients on PN
1 preterm infants and
2 full term infants in the Neonatal Intensive Care Unit NICU requiring prolonged PN and
3 older infants and young children on home PN
Mn neurotoxicity will be investigated by longitudinal assessments of cognitive executive functioning battery neurodevelopmental Bayley III Scales of Infant Development and psychophysiological event-related potential measures and will be correlated with brain deposition of Mn using the technique of magnetic resonance MR relaxometry in a vulnerable population of infants receiving Mn-supplemented PN and age-matched controls This proposal addresses a clinically relevant and unexplored link between nutritional practices brain Mn deposition and neurodevelopmental sequelae in an at-risk population of infants and young children utilizing state-of-the-art magnetic resonance imaging MRI technology and neurodevelopmental assessment techniques The potential for increased brain Mn accumulation in infants and by inference the potential health risks associated with elevated brain Mn burden represents crucial unexplored issues of exposure and susceptibility The potential contribution of Mn toxicity to the poor outcomes of infants dependent for an extended time on PN has not been fully acknowledged or studied Improved understanding of the relationships between Mn exposure and developmental outcomes will undoubtedly lead to altered clinical practices and more careful monitoring of Mn intake and blood andor brain Mn levels in high risk infants Our studies will also contribute to an improved understanding of the value of non-invasive MR imaging in the monitoring of pediatric patients on PN
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ES013730 | None | None | None |