Clinical Trials Logo
  1. Home
  2. Necrotizing Enterocolitis
  3. NCT00392730

Neurodevelopment and Neuroimaging in Parenterally-fed Infants and Young Children

Necrotizing Enterocolitis Clinical Trial

Official title:
Neurodevelopment and Neuroimaging in Parenterally-fed Infants and Young Children

Clinical Trial 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.

Clinical Trial 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 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. ;

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00392730
Study type Observational
Source Vanderbilt University
Contact
Status Completed
Phase N/A
Start date August 2006
Completion date December 2010
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05544097 - Spectral Analysis of Bowel Sounds in Preterm Babies of Less Than 32 Weeks of Amenorrhea (WA) as Predictive Factor of Enterocolitis N/A
Recruiting NCT03210831 - Early Predictors of Necrotizing Enterocolitis in Neonates
Not yet recruiting NCT06045130 - PUFAs in Preterm Infants
Recruiting NCT02552706 - The Efficacy and Mechanisms of Oral Probiotics in Preventing Necrotizing Enterocolitis N/A
Completed NCT02400697 - Placental Transfusion Project for Preterm Infants N/A
Completed NCT01751477 - Infloran® for Prevention of Necrotizing Enterocolitis N/A
Terminated NCT01156480 - Anti-inflammatory Treatment at the Onset of Necrotizing Enterocolitis (NEC) in Preterm Infants N/A
Completed NCT00787124 - Transfusions and Nitric Oxide Level in Preterm Infants
Unknown status NCT00254176 - Cysteine Supplementation in Critically Ill Neonates Phase 2/Phase 3
Recruiting NCT01441739 - Intestinal Failure in Necrotising Enterocolitis N/A
Recruiting NCT03869827 - Necrotizing Enterocolitis in Fetuses With Intrauterine Growth Restriction
Recruiting NCT04074824 - A Genome-Wide Association Study for Neonatal Diseases
Terminated NCT03320785 - Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation
Active, not recruiting NCT03554278 - Alteration of Stool Microbiota in Preterm Infants With Anemia
Not yet recruiting NCT04541771 - The Role of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants Phase 2
Not yet recruiting NCT03700957 - The Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates N/A
Completed NCT03551600 - Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
Completed NCT01745510 - Enteral Administration of Docosahexaenoic Acid to Prevent Necrotizing Enterocolitis in Preterm Neonates Phase 1/Phase 2
Unknown status NCT01807858 - The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants N/A
Completed NCT01735578 - Splanchnic Tissue Oxygenation During Enteral Feedings in Anemic Premature Infants at Risk for Necrotizing Enterocolitis N/A