PMID- 31567786
OWN - NLM
STAT- MEDLINE
DCOM- 20201009
LR  - 20201009
IS  - 1536-4801 (Electronic)
IS  - 0277-2116 (Print)
IS  - 0277-2116 (Linking)
VI  - 69
IP  - 6
DP  - 2019 Dec
TI  - Safety of a Triple-chamber Bag Parenteral Nutrition in Children Ages up to 24 
      Months: An Observational Study.
PG  - e151-e157
LID - 10.1097/MPG.0000000000002512 [doi]
AB  - 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.
FAU - Arnell, Henrik
AU  - Arnell H
AD  - Karolinska University Hospital Department of Paediatric Gastroenterology, 
      Hepatology and Nutrition, and Department of Women's and Children's Health, 
      Karolinska Institutet, Stockholm, Sweden.
FAU - Valla, Frederic V
AU  - Valla FV
AD  - Paediatric Intensive Care Unit, Hospices Civils de Lyon, Lyon-Bron, France.
FAU - Malfilatre, Genevieve
AU  - Malfilatre G
AD  - Neonatal Intensive Care Unit, CHU Tivoli, La Louviere, Belgium.
FAU - Pladys, Patrick
AU  - Pladys P
AD  - Service Pediatrie and CIC1414, CHU Rennes, Rennes, France.
FAU - Senterre, Thibault
AU  - Senterre T
AD  - Department of Neonatology, CHU de Liege, CHR de la Citadelle, University of 
      Liege, Belgium and Baxter Healthcare Corporation, Braine-L'Alleud, Belgium.
FAU - Pontes-Arruda, Alessandro
AU  - Pontes-Arruda A
AD  - Baxter Healthcare Corporation, Deerfield, IL.
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Pediatr Gastroenterol Nutr
JT  - Journal of pediatric gastroenterology and nutrition
JID - 8211545
RN  - 0 (Parenteral Nutrition Solutions)
RN  - I38ZP9992A (Magnesium)
SB  - IM
MH  - Child, Preschool
MH  - Energy Intake
MH  - Female
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - Magnesium/*blood
MH  - Male
MH  - Parenteral Nutrition/adverse effects/*methods
MH  - Parenteral Nutrition Solutions/*administration & dosage/adverse effects
MH  - Prospective Studies
PMC - PMC6882531
COIS- T.S. has become an employee of Baxter Healthcare Corporation after study 
      completion. A.P.-A. was an employee of Baxter Healthcare Corporation at the time 
      of the study and is a shareholder of Baxter Healthcare Corporation. F.V., G.M., 
      and T.S. have received study support from Baxter Healthcare Corporation. H.A., 
      F.V., G.M., and T.S. have received financial support for other work from Baxter 
      Healthcare Corporation. P.P. has no conflicts of interest to declare.
EDAT- 2019/10/01 06:00
MHDA- 2020/10/10 06:00
PMCR- 2019/11/28
CRDT- 2019/10/01 06:00
PHST- 2019/10/01 06:00 [pubmed]
PHST- 2020/10/10 06:00 [medline]
PHST- 2019/10/01 06:00 [entrez]
PHST- 2019/11/28 00:00 [pmc-release]
AID - JPGN-18-944 [pii]
AID - 10.1097/MPG.0000000000002512 [doi]
PST - ppublish
SO  - J Pediatr Gastroenterol Nutr. 2019 Dec;69(6):e151-e157. doi: 
      10.1097/MPG.0000000000002512.