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Neurodevelopment and Neuroimaging in Parenterally-fed Infants and Young Children

NCT ID: NCT00392730

Last Updated: 2013-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

122 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-08-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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 and/or 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.

Conditions

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Parenteral Nutrition Necrotizing Enterocolitis Digestive System Abnormalities Cholestasis

Keywords

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Manganese Neonatal Intensive Care MRI Parenteral Nutrition Prematurity

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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1

Preterm infants in NICU and age-matched controls

Remove Mn from PN if evidence of increased brain Mn on MRI

Intervention Type DIETARY_SUPPLEMENT

Withhold Mn-containing trace element cocktail and add zinc, copper and chromium individually to PN

2

Term infants in NICU and age-matched controls

Remove Mn from PN if evidence of increased brain Mn on MRI

Intervention Type DIETARY_SUPPLEMENT

Withhold Mn-containing trace element cocktail and add zinc, copper and chromium individually to PN

3

Children on home PN (to age 6) and age-matched controls

Remove Mn from PN if evidence of increased brain Mn on MRI

Intervention Type DIETARY_SUPPLEMENT

Withhold Mn-containing trace element cocktail and add zinc, copper and chromium individually to PN

Interventions

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Remove Mn from PN if evidence of increased brain Mn on MRI

Withhold Mn-containing trace element cocktail and add zinc, copper and chromium individually to PN

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Greater than 30 days postnatal age
2. In the preceding four weeks, have received \>75% of their nutrition as Mn-supplemented PN
3. Clinically stable for transport to the MR facility
4. Signed parental consent.

Or healthy age-matched controls

Exclusion Criteria

1. Any infant not expected to survive to the age of 3 months or
2. Not expected to achieve sufficient clinical stability to tolerate the MRI procedure.
Minimum Eligible Age

30 Days

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Gerber Foundation

OTHER

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Judy Aschner

Adjunct Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Judy L Aschner, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt Children's Hospital

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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Aschner JL, Aschner M. Nutritional aspects of manganese homeostasis. Mol Aspects Med. 2005 Aug-Oct;26(4-5):353-62. doi: 10.1016/j.mam.2005.07.003.

Reference Type BACKGROUND
PMID: 16099026 (View on PubMed)

Fitsanakis VA, Zhang N, Avison MJ, Gore JC, Aschner JL, Aschner M. The use of magnetic resonance imaging (MRI) in the study of manganese neurotoxicity. Neurotoxicology. 2006 Sep;27(5):798-806. doi: 10.1016/j.neuro.2006.03.001. Epub 2006 Apr 18.

Reference Type BACKGROUND
PMID: 16620989 (View on PubMed)

Fitsanakis VA, Piccola G, Marreilha dos Santos AP, Aschner JL, Aschner M. Putative proteins involved in manganese transport across the blood-brain barrier. Hum Exp Toxicol. 2007 Apr;26(4):295-302. doi: 10.1177/0960327107070496.

Reference Type BACKGROUND
PMID: 17615110 (View on PubMed)

Yin Z, Aschner JL, dos Santos AP, Aschner M. Mitochondrial-dependent manganese neurotoxicity in rat primary astrocyte cultures. Brain Res. 2008 Apr 8;1203:1-11. doi: 10.1016/j.brainres.2008.01.079. Epub 2008 Feb 11.

Reference Type BACKGROUND
PMID: 18313649 (View on PubMed)

Aschner JL, Anderson A, Slaughter JC, Aschner M, Steele S, Beller A, Mouvery A, Furlong HM, Maitre NL. Neuroimaging identifies increased manganese deposition in infants receiving parenteral nutrition. Am J Clin Nutr. 2015 Dec;102(6):1482-9. doi: 10.3945/ajcn.115.116285. Epub 2015 Nov 11.

Reference Type DERIVED
PMID: 26561627 (View on PubMed)

Other Identifiers

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ES013730

Identifier Type: -

Identifier Source: secondary_id

Gerber07-01-06JLA

Identifier Type: -

Identifier Source: org_study_id