Division of Gastroenterology, Hepatology and Nutrition Copper Status In Infants With Prolonged Dependence On Parenteral Nutrition

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Principal Investigator: Danielle Arsenault, FNP-BC

Department: The Division of GI/Nutrition; Center for Advanced Intestinal Rehabilitation (CAIR)

Protocol Status: Open for Recruitment

Trial Description: The purpose of this study is to determine the frequency of copper deficiency in infants on parenteral nutrition (PN), and to correlate these findings with clinical, demographic and nutritional risk factors. Copper is known to play a critical role in many important physiologic processes; however little is know about optimal dosing of this micronutrient in PN-dependent infants. The findings of this study will serve to guide clinical practice regarding provision of the appropriate amount of copper in this patient population.

Study procedures: PN-dependent infants enrolled in this study will undergo laboratory testing and growth assessment every 8 weeks for the duration of PN-dependence or until conclusion of the 1 year study period. Data will also be collected about types and amounts of gastrointestinal losses as well as the parenteral and enteral intake of copper and other specific nutrients.  

Compensation: There is no compensation for participating in this study beyond contribution to the greater knowledge about optimal copper provision in the PN-dependent infant population.

Recruitment Info: Infants less than 1 year of age (adjusted for prematurity) that have been PN-dependent for a minimum of 30 days and will likely continue to be PN-dependent for a minimum of 8 weeks following enrollment will be recruited for this study.

Recruitment Contact Phone: 617-919-3505

Recruitment Contact Email: danielle.arsenault@childrens.harvard.edu

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