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Sponsors and Collaborators: |
Vanderbilt University National Institute of Environmental Health Sciences (NIEHS) |
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Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00392977 |
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.
Condition | Intervention |
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Necrotizing Enterocolitis Digestive System Abnormalities Cholestasis |
Dietary Supplement: remove Mn from PN if evidence of increased brain Mn on MRI |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Brain Manganese Deposition in High Risk Neonates |
Blood
Estimated Enrollment: | 40 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | November 2010 |
Manganese (Mn) is an essential metal needed for normal growth and development. Excessive environmental or dietary exposure results in Mn deposition in Mn-sensitive brain regions causing adverse psychological and 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, PN bypasses the normal intestinal absorptive control and biliary excretory mechanisms for Mn, and infants are at a critical stage of brain development. Furthermore, iron (Fe) deficiency, a common problem among sick neonates, increases Mn brain uptake because Mn and Fe compete for the same carrier transport systems in the central nervous system. This proposal will investigate brain deposition of Mn, a paramagnetic element, by magnetic resonance (MR) imaging in 40 neonates receiving Mn-supplemented PN and 10 control infants.
Two specific aims will test the following hypotheses:
Shortening of MR T1 and T2 relaxation times (a marker for Mn) in Mn-sensitive brain regions in neonates receiving PN will correlate directly with
shortening of T1 and T2 relaxation times will correlate inversely with
The potential for increased brain Mn accumulation in infants and the potential health risks associated with elevated brain Mn burden represent crucial, unexplored issues of exposure and susceptibility. The impact of dietary Mn, and especially parenterally delivered dietary Mn, gestational age, Fe status, and hepatic dysfunction on the ability of the neonatal brain to regulate Mn deposition has not been scientifically addressed. The proposed clinical investigation has enormous health significance and may shed light on the development and progression of neurological dysfunction in infants and children on prolonged parenteral nutrition.
Ages Eligible for Study: | up to 12 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Neonates in the NICU on prolonged PN
Inclusion Criteria:
Exclusion Criteria:
Contact: Judy L Aschner, MD | 615 322-3476 | judy.aschner@vanderbilt.edu |
Contact: Steven Steele, RN | 615.322.0299 | steven.steele@vanderbilt.edu |
United States, Tennessee | |
Vanderbilt Children's Hospital | Recruiting |
Nashville, Tennessee, United States, 37232-9544 | |
Contact: Judy L Aschner, MD 615-322-3476 judy.aschner@vanderbilt.edu | |
Contact: Steven D Steele, RN 615 322-0558 steven.steele@vanderbilt.edu | |
Principal Investigator: Judy L Aschner, MD |
Principal Investigator: | Judy L Aschner, MD | Vanderbilt University |
Responsible Party: | Vanderbilt University Medical Center ( Judy L. Aschner, MD ) |
Study ID Numbers: | ES013730, ES013730 |
Study First Received: | October 25, 2006 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00392977 History of Changes |
Health Authority: | United States: Institutional Review Board |
Manganese Neonatal Intensive Care MRI Parenteral Nutrition Prematurity |
Chromium Cholestasis Gastrointestinal Diseases Necrotizing Enterocolitis Trace Elements Copper Intestinal Diseases Enterocolitis Digestive System Abnormalities |
Digestive System Diseases Bile Duct Diseases Biliary Tract Diseases Zinc Micronutrients Enterocolitis, Necrotizing Congenital Abnormalities Gastroenteritis Manganese |
Cholestasis Gastrointestinal Diseases Growth Substances Physiological Effects of Drugs Trace Elements Intestinal Diseases Enterocolitis Pharmacologic Actions Digestive System Abnormalities |
Digestive System Diseases Bile Duct Diseases Biliary Tract Diseases Micronutrients Congenital Abnormalities Enterocolitis, Necrotizing Gastroenteritis Manganese |