Un paso más en seguridad en nutrición parenteral pediátrica Translated title: On step more in safety in pediatric parenteral nutrition

Aluminum (Al) is a contaminant in all parenteral nutrition (PN) solution component products. Manufacturers currently label these products with the maximum Al content at the time of expiry. We recently published data to establish the actual measured concentration of Al in PN solution products prior to being compounded in the clinical setting [1]. The investigation assessed quantitative Al content of all available products used in the formulation of PN solutions. The objective of this study was to assess the Al exposure in neonatal patients using the least contaminated PN solutions and determine if it is possible to meet the FDA “safe limit” of less than 5 μg/kg/day of Al. The measured concentrations from our previous study were analyzed and the least contaminated products were identified. These concentrations were entered into our PN software and the least possible Al exposure was determined. A significant decrease (41%–44%) in the Al exposure in neonatal patients can be achieved using the least contaminated products, but the FDA “safe limit” of less than 5 μg/kg/day of Al was not met. However, minimizing the Al exposure may decrease the likelihood of developing Al toxicity from PN.

Aluminum toxicity has been described in patients of all ages who are receiving a variety of therapies, including dialysis, phosphate-binding medications, and parenteral nutrition (PN). Neonates are at an increased risk of aluminum toxicity because of anatomic, physiologic, and nutrition-related factors not present in other populations. In 2004, the Food and Drug Administration recommended restricting daily aluminum administration to 5 μg/kg/day and now requires that additives used to compound PN have the maximum aluminum content at expiration listed on the product label. Although the pharmacist can work to decrease aluminum toxicity in this population, it remains difficult to reach this threshold.