Safety of a Triple-chamber Bag Parenteral Nutrition in Children Ages up to 24 Months An Observational Study - Archive ouverte HAL Access content directly
Journal Articles Journal of Pediatric Gastroenterology and Nutrition Year : 2019

Safety of a Triple-chamber Bag Parenteral Nutrition in Children Ages up to 24 Months An Observational Study

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G. Malfilâtre
  • Function : Author
T. Senterre
  • Function : Correspondent author
A. Pontes-Arruda
  • Function : Author

Abstract

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, >1-12, 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 ages 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 to 0.3 mmol · kg · day in this population.

Dates and versions

hal-02499729 , version 1 (05-03-2020)

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Cite

H. Arnell, F.V. Valla, G. Malfilâtre, P. Pladys, T. Senterre, et al.. Safety of a Triple-chamber Bag Parenteral Nutrition in Children Ages up to 24 Months An Observational Study. Journal of Pediatric Gastroenterology and Nutrition, 2019, 69 (6), pp.E151-E157. ⟨10.1097/MPG.0000000000002512⟩. ⟨hal-02499729⟩
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