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NCT Number: NCT00392730

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 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.

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Key information

Conditions

Parenteral Nutrition Bile Duct Diseases Biliary Tract Diseases Cholestasis Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Female Urogenital Diseases and Pregnancy Complications Gastroenteritis Gastrointestinal Diseases Hyperphagia Intestinal Diseases Necrotizing Enterocolitis Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Signs and Symptoms Signs and Symptoms, Digestive Urogenital Diseases

Age range

30 day–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt Children's Hospital

Nashville, Tennessee, 37232-9544, United States

About this study

Specific Aims have been designed to test these hypotheses in three developmentally distinct populations:

  • preterm infants and
  • full term infants in the Neonatal Intensive Care Unit (NICU) requiring prolonged PN and
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Or healthy age-matched controls

Exclusion criteria

  • Any infant not expected to survive to the age of 3 months or
  • Not expected to achieve sufficient clinical stability to tolerate the MRI procedure.

Treatment and study plan

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

Dietary Supplement

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

Primary outcomes

  1. Brain Mn deposition measured by MR relaxometry

    Time frame: baseline (at study enrolment)

    Mn neurotoxicity will be investigated by magnetic resonance (MR) relaxometry in a population of infants receiving Mn-supplemented parenteral nutrition and age-matched controls.

Secondary outcomes

  1. Neurodevelopmental outcomes

    Time frame: 2 years

    Neurodevelopment will be investigated by longitudinal assessments of cognitive (executive functioning battery), neurodevelopmental (Bayley III Scales of Infant Development), and psychophysiological (event-related potential) measures

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • The Gerber Foundation

Registry information

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Oct 26, 2006
Registry last updated
Dec 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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