Preterm newborns receiving commercial pediatric triple-chamber bag (3CB) parenteral feeding have been documented to have hypermagnesemia (PN). The European Medicines Agency ordered this postmarketing research to evaluate the safety of a 3CB PN product in full-term newborns and children up to 24 months of age. This prospective, multicenter, observational trial involved hospitalized, full-term newborn babies and children up to 24 months of age who were getting more than 70% of their nutrition as PN and required more than 50% of their nutrition as PN for 5 days. During the trial period of less than or equal to 15-days, all patients received 3CB PN. The primary outcome was serum magnesium levels, which were summarized by age group (0–1, more than 1–12, and more than 12–24 months). On the other hand, vital signs and clinically significant abnormal laboratory results along with nutritional intake and adverse events were recorded.
A total of 102 eligible patients were enrolled in the study. The average parenteral magnesium consumption was 0.23 (0.18–0.30) mmol · kg−1 · day−1. In any age group, mean serum magnesium exhibited no consistent changes throughout therapy. One significant and three mild hypermagnesemia-related adverse events (AEs) were recorded in four patients (3.9%), ranging in age from 0 to 1 month. Hypertriglyceridemia (6.9%), laryngitis (3.9 percent), hyperkalemia, hypokalemia, hyponatremia, hypophosphatemia, and newborn hypotension were the other AEs in more than two individuals (each 2.9 percent ). Other serum electrolytes were steady and showed no signs of toxicity.
In full-term newborns and children up to 24 months of age, 3CB PN had no effect on mean blood magnesium levels. In this cohort, the risk of hypermagnesemia AEs was modest when median parenteral magnesium of 0.2 to 0.3 mmol kg1 day1 was administered.
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