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

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.

SUBMITTER: Arnell H

PROVIDER: S-EPMC6882531 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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

Arnell Henrik H Valla Frederic V FV Malfilâtre Geneviève G Pladys Patrick P Senterre Thibault T Pontes-Arruda Alessandro A

Journal of pediatric gastroenterology and nutrition 20191201 6

<h4>Objectives</h4>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.<h4>Methods</h4>This prospective, multicenter, observational study enrolled hospitalized, full-term, newborn infants and children up to 24 months of age receiving >70% of ...[more]

PMID: 31567786

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Project description:Background and objectivePatients on parenteral nutrition (PN) are at high risk of both liver and pancreatic injury. More efforts were focused on liver, however, limited data is available to evaluate the effects of PN on pancreas. Thus, we performed a retrospective observational study to evaluate the association between PN and pancreatic injury in Chinese adult patients.MethodsAdult patients (18-80 years), who received PN for a week or longer, and with repeated measurements of pancreatic enzymes, were included in the analysis. Pancreatic injury was confirmed by serum level of pancreatic amylase (P-AMYwas 53 U/L or higher) or lipase (LP was 63 U/L or higher), which were evaluated at baseline and following every week during PN duration. Age, sex, body weight, height, diagnosis of diseases, history of diseases, surgery, white blood cell, c-reactive protein, liver and renal function, fasting blood glucose, lipid profile, and daily energy supplied by PN and enteral nutrition were abstracted from medical records.ResultsA total number of 190 adult patients (125 men, 65 women) were included in the study. The average age and BMI were 61.8 ± 13.0 years and 21.7±3.3 kg/m2, while medium serum level of P-AMY and LP were 29.0 U/L (quartile range: 18.0, 47.0) and 33.0 U/L (quartile range: 19.0, 58.0), respectively at baseline. The median duration of PN was 15 days (quartile range: 11.0, 21.0). The prevalence of pancreatic injury was 42.1% (80/190) while it was 28.4% (54/190), 43.3% (77/178), 47.8% (44/92) after one-, two-, and three-week or longer PN adminstration. The proportion of daily energy supplement by PN (OR = 3.77, 95%CI: 1.87, 7.61) and history of infection were positively (OR = 3.00, 95%CI: 1.23, 7.36), while disease history for diabetes mellitus (OR = 0.38, 95%CI: 0.15, 0.98) and cancer (OR = 0.46, 95%CI: 0.23, 0.95), were negetively associated with pancreatic injury. Total bile acids were associated with the increment of P-AMY (beta = 0.98, 95%CI: 0.39, 1.56) and LP (beta = 2.55, 95%CI: 0.98, 4.12) by multi-variate linear regression.ConclusionPN was associated with pancreatic injury, as demonstrated by the increase of both serum P-AMY and LP.

Dataset Information

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

Publications

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

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