Elsevier

Nutrition

Volume 49, May 2018, Pages 41-47
Nutrition

Basic nutritional investigation
Physicochemical stable standard all-in-one parenteral nutrition admixtures for infants and children in accordance with the ESPGHAN/ESPEN guidelines

https://doi.org/10.1016/j.nut.2017.11.019Get rights and content

Highlights

  • Standard all-in-one (AIO) parenteral nutrition admixtures for pediatric patients from birth to adolescence were developed that meet the ESPGHAN/ESPEN guidelines.

  • Long-term physicochemical stability was tested in two-compartment EVAM bags for 80 d at 2° to 8°C + 24 h at room temperature (RT).

  • An additional physicochemical stability was obtained of 7 d 2° to 8°C + 48 h RT after reconstitution to an AIO admixture including vitamins and trace elements.

  • Long-term stability allows batchwise production and availability at all times for clinical use in hospital and home care setting.

Abstract

Objective

Because there are almost no standard all-in-one parenteral nutrition admixtures available for infants and children, the aim was to develop standard two-compartment parenteral nutrition bags for different weight categories based on the ESPGHAN/ESPEN (European Society of Paediatric Gastroenterology, Hepatology and Nutrition/European Society for Clinical Nutrition and Metabolism) guidelines. The 1 g/kg/d lipid version for the 3 to 10 kg weight category (PED1) was assessed for short- and long-term physicochemical stability with the ability to add additional electrolytes (PED1+E).

Methods

The lipid compartment A and the all-in-one admixture of A + B + vitamins + trace elements were assessed physically by visual inspection, Sudan red test, pH measurement, and lipid droplet size distribution. Chemical stability for compartment A was evaluated by quantitative analyses of non-esterified fatty acids and peroxide content. The glucose–amino acid–electrolyte compartment B was evaluated physically by visual inspection, measuring particle contamination and pH. Chemical stability was assessed by discoloration, quantitative analyses of glucose, and the amino acids L-cysteine, L-tyrosine, and L-tryptophan.

Results

No phase separation or coalescence occurred, and the mean droplet size diameter did not exceed 0.5 µm. Peroxide content and non-esterified fatty acids concentration of compartment A remained well below the limit of acceptation. No precipitation was detected for compartment B; only a slight yellow discoloration was noted at 80 d. Concentrations of glucose, L-tyrosine, and L-tryptophan remained stable; only L-cysteine decreased significantly from its initial concentration.

Conclusion

The two-compartment PED1 and PED1+E admixtures are stable up to 80 d 2° to 8°C + 24 h room temperature (RT) with an additional 7 d 2° to 8°C + 48 h RT after mixing and addition of vitamins and trace elements.

Introduction

Nutritional support is an essential component in the treatment of pediatric patients. In patients where oral or enteral (tube) feeding is insufficient to meet nutritional needs, parenteral nutrition (PN) will be initiated to avoid nutritional deficiencies. This can be the case in situations such as short bowel syndrome, abdominal surgery, chronic intestinal pseudoobstruction, chemotherapy, and bone marrow or organ transplantations complicated by ileus.

A range of standard PN admixtures is commercially available for adults, which is not the case for children. Nutritional needs in children vary according to their weight and age. PN for pediatric patients is hence often prescribed individually and compounded day by day in the hospital pharmacy or on the ward by the nursing staff [1].

Lipid emulsions are often administered separately in Y-site to the other macronutrients. Although standard pediatric PN bags have been described, these standard PN bags are not complete. Supplementation of essential minerals (e.g., magnesium) [1], [2] or of some macronutrients and electrolytes is still needed [3], [4]. Furthermore the stability data of these PN bags are often limited to PN admixtures for premature infants or neonates [2], [3], [5], [6].

The individualized prescribing or compounding of PN has inherent important disadvantages, such as an increased risk of inadequate or erroneous calculation of nutritional needs and an increased risk of mixing errors. Furthermore, physical and chemical incompatibilities are not reckoned and all manipulations carry inherently an increased infection risk [7].

Based on the ESPGHAN/ESPEN (European Society of Paediatric Gastroenterology, Hepatology and Nutrition/European Society for Clinical Nutrition and Metabolism) 2005 guidelines on PN for pediatric patients standard all-in-one (AIO) PN admixtures for patients weighing 3 kg (from birth) to 31 kg or more (adolescence) were developed [8]. These standard admixtures were adapted for both in hospital (continuous administration) and home care use (cyclic administration). Their physicochemical stability in two-compartment bags for 80 d at 2° to 8°C + 24 h RT has been tested as well as an additional 7 d at 2° to 8°C + 48 h at RT after reconstitution to an AIO admixture including vitamins and trace elements. Long-term stability has the advantage that these standard PN admixtures can be produced batchwise and are available at all times for clinical use.

Section snippets

Composition of PN admixtures

To cover the nutritional needs of children of different weight and age, PN admixtures for 4 weight categories were developed: 3 to 10 kg (PED1), 11 to 20 kg, 21 to 30 kg, and >31 kg. Within each weight category a 2 g/kg/d lipid version (hospital admixture), a 1 g/kg/d lipid version (home admixture), and a binary version (no lipids) was developed. For all eight lipid-containing AIO admixtures a lipid emulsion containing a mixture of soybean oil, medium chain triacylglycerols, olive oil, and fish

Composition of standard pediatric PN admixtures

Using the previously mentioned fluid volumes calculated per kilogram of ideal body weight, all macronutrients (glucose, lipids, amino acids) and electrolytes (Na, K, Ca, Mg, and PO4) fall within the recommended ESPGHAN/ESPEN minimum and maximum ranges for each infant or child of any age. The composition (macronutrients and electrolytes) of the 12 standard PN admixtures per kilogram of body weight for the four different weight categories, 3 to 10 kg, 11 to 20 kg, 21 to 30 kg, and >31 kg, is

Discussion

The goal of the study was to develop standard AIO PN admixtures for pediatric patients from birth to adolescence, which were stable on a long-term basis and followed the recommendations on PN by the ESPGHAN/ESPEN guidelines. Ready-to-use PN bags are cost effective, less at risk for composition errors, and less at risk for bacterial contamination [7], [13], [14]. They can be immediately available on the ward or used for home care purposes, even when the pharmacy is closed.

The development of

Conclusion

Standard AIO PN admixtures have been developed complying with the ESPGHAN/ESPEN 2005 guidelines for nutritional needs in pediatric patients from birth until adolescence. Based on our stability data (80 d 2–8°C + 24 h RT two-compartment bag followed by 7 d 2–8°C + 48 h RT after mixing and addition of vitamins and trace elements), standard pediatric PN admixtures for all different weight categories can be compounded batchwise. Storage of the AIO PN bags is possible for 1 wk in the refrigerator

Acknowledgments

J. De Cloet was involved in the conception and design of the study, acquisition of data, analysis and interpretation of data and drafted the manuscript. M. Van Winckel was involved in conception and design of the study, participated in drafting the article and revised it critically for important intellectual content. S. Van Biervliet contributed in drafting the article and revising it critically for important intellectual content. All authors read and approved the final version of the

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