Evaluating Differences in Aluminum Exposure through Parenteral Nutrition in Neonatal Morbidities

Abstract

Aluminum is a common contaminant in many components of parenteral nutrition, especially calcium and phosphate additives. Although long-term effects have been described in the literature, short-term effects are not well-known. Currently, the Food and Drug Administration recommends maintaining aluminum at <5 mcg/kg/day. This was a single center, retrospective case-control study of 102 neonatal intensive care unit patients. Patients were included if they had a diagnosis of necrotizing enterocolitis, rickets/osteopenia, or seizures and received at least 14 days of parenteral nutrition. Patients were matched 1:1 with control patients by gestational age and birth weight. Mean total aluminum exposure for the 14 days of parenteral nutrition was calculated using manufacturer label information. Differences in mean aluminum exposure between cases and controls, as well as subgroup analysis in those with renal impairment or cholestasis, was conducted. Aluminum exposure in patients meeting inclusion criteria closely mirrored the aluminum exposure of control patients. The difference in aluminum exposure was not found to be statistically significant, except in patients with cholestasis. Although the study found no difference in aluminum exposure in short-term complications with neonates, long-term complications are well established and may warrant the need to monitor and limit neonatal aluminum exposure.

Aluminium release by coated and uncoated fluid‐warming devices

“…Nevertheless, the threshold for a ‘safe’ aluminium concentration is still debated. Whether aluminium causes short‐term complications remains unclear , but long‐term complications with neurological impairment in pre‐term infants and bone aluminium accumulation with resulting osteomalacia in adults receiving parenteral nutrition are well known.…”

“…The actual effect of aluminium released in this way is unclear. Toxic effects of aluminium and accidental intravenous administration have been discussed in the context of parenteral nutrition, especially for pre‐term infants . The American Society for Clinical Nutrition and the American Society for Parenteral and Enteral Nutrition recommend a threshold of 25 μg.l −1 ; also noted by the US FDA .…”

“…A repeated intravenous supply > 4–5 μg.kg −1 .day −1 can present a sufficient aluminium burden as to be associated with encephalopathy, impaired neurologic development and osteomalacia . United States regulations aimed to control aluminium concentrations in large volume parenteral fluids to a maximum of 25 μg.l −1 .…”

A Study on Aluminium Levels in Patients Undergoing Haemodialysis at a Tertiary Care Hospital

“…Ninetynine percent of the aluminium is excreted from the body via renal function. 20 Aluminium is used in consumer goods including: antacids, astringents, buffered aspirin, food additives, antiperspirants, cosmetics, medication packaging, etc.…”

An Assessment of aluminum contamination in neonatal parenteral nutrition solutions based on measured versus labeled content

“…( Table 1 ); 3 samples were from the ready-made PNS prepared for three newborns in different weights in the NICUs ( Table 2 ). Table 2 shows the Al content of the additives were derived from the manufactures, pharmacopeias and published studies ( Bohrer et al, 2001 , Food and Drug Administration, 2000 , Food and Drug Administration, 2002 , Migaki et al, 2012 , Poole et al, 2011 , Huston et al, 2012 , Fortenberry et al, 2017 Nov 16 , Europian pharmacopeia 6.0. vol.1, General notices . london: Medicines and Healthcare products Regulatory Agency;, 2008 , The United States pharmacopeia.…”