Safety of a Triple-Chamber Bag Parenteral Nutrition in Children Aged up to 24 Months: An Observational Study

Objectives Hypermagnesemia has been reported in preterm neonates treated with commercial pediatric triple-chamber bag (3CB) parenteral nutrition (PN). This postmarketing study was requested by the European Medicines Agency to assess the safety of a 3CB PN product in full-term neonates and children up to 24 months of age. Methods This prospective, multicenter, observational study enrolled hospitalized, full-term, newborn infants and children up to 24 months of age receiving >70% of nutrition as PN and requiring ≥50% of nutrition as PN for ≥5 days. All patients received 3CB PN during the study for ≤15 days. The primary outcome was serum magnesium, summarized by age group (0.1 month, >1.12 months, and >12.24 months). Secondary outcomes were nutritional intake and adverse events (AEs), including clinically significant abnormal laboratory results and vital signs. Results A total of 102 eligible patients were included. Median (interquartile range) parenteral magnesium intake was 0.23 (0.18.0.30) mmol/kg/day. Mean serum magnesium showed no consistent changes during treatment in any age group. One moderate and 3 mild AEs of hypermagnesemia were reported in 4 patients (3.9%), all aged 0 to 1 month. Other AEs in >2 patients were hypertriglyceridemia (6.9%), laryngitis (3.9%), hyperkalemia, hypokalemia, hyponatremia, hypophosphatemia, and neonatal hypotension (each 2.9%). Other serum electrolytes were stable and revealed no safety concerns. Conclusions Mean serum magnesium levels were not affected by 3CB PN in full-term neonates and children up to 24 months of age. The risk of hypermagnesemia AEs was low when providing median parenteral magnesium of 0.2.0.3 mmol/kg/day in this population. © 2019 The Author(s).