Nutritional Support for Moderate-to-Late-Preterm Infants - A Randomized Trial.

BACKGROUND: Most moderate-to-late-preterm infants need nutritional support until they are feeding exclusively on their mother's breast milk. Evidence to guide nutrition strategies for these infants is lacking. METHODS: We conducted a multicenter, factorial, randomized trial involving infants born at 32 weeks 0 days' to 35 weeks 6 days' gestation who had intravenous access and whose mothers intended to breast-feed. Each infant was assigned to three interventions or their comparators: intravenous amino acid solution (parenteral nutrition) or dextrose solution until full feeding with milk was established; milk supplement given when maternal milk was insufficient or mother's breast milk exclusively with no supplementation; and taste and smell exposure before gastric-tube feeding or no taste and smell exposure. The primary outcome for the parenteral nutrition and the milk supplement interventions was the body-fat percentage at 4 months of corrected gestational age, and the primary outcome for the taste and smell intervention was the time to full enteral feeding (150 ml per kilogram of body weight per day or exclusive breast-feeding). RESULTS: A total of 532 infants (291 boys [55%]) were included in the trial. The mean (±SD) body-fat percentage at 4 months was similar among the infants who received parenteral nutrition and those who received dextrose solution (26.0±5.4% vs. 26.2±5.2%; adjusted mean difference, -0.20; 95% confidence interval [CI], -1.32 to 0.92; P = 0.72) and among the infants who received milk supplement and those who received mother's breast milk exclusively (26.3±5.3% vs. 25.8±5.4%; adjusted mean difference, 0.65; 95% CI, -0.45 to 1.74; P = 0.25). The time to full enteral feeding was similar among the infants who were exposed to taste and smell and those who were not (5.8±1.5 vs. 5.7±1.9 days; P = 0.59). Secondary outcomes were similar across interventions. Serious adverse events occurred in one infant. CONCLUSIONS: This trial of routine nutrition interventions to support moderate-to-late-preterm infants until full nutrition with mother's breast milk was possible did not show any effects on the time to full enteral feeding or on body composition at 4 months of corrected gestational age. (Funded by the Health Research Council of New Zealand and others; DIAMOND Australian New Zealand Clinical Trials Registry number, ACTRN12616001199404.).

One-chamber and two-chamber parenteral nutrition admixtures for pediatric and adult patients: An evaluation of physico-chemical stability at room and cold temperature.

OBJECTIVES: The aim of this study was to evaluate the physico-chemical stability of compounded total parenteral nutrition admixtures through peroxidation assay and ultraviolet-visible spectroscopy, high-performance liquid chromatography analysis, nuclear magnetic resonance spectrometry, pH meter, and dynamic light scattering. METHODS: The present study considered parenteral nutrition (PN) admixtures for pediatric and adult patients. The admixtures were characterized by a high content of vitamins and trace elements. They were prepared in one- or two-chamber bags in the hospital pharmacy using an automatic compounding system in a sterile room with laminar airflow at different temperature conditions and light exposure. The experiment setup comprised fat emulsions, lipid-free PN solutions, and single-chamber bags before and after adding vitamins and trace elements. The stability at room temperature (+25°C) and cold temperature (+2-8°C) was assessed by various means. RESULTS: Two-compartment admixtures, single-chamber bags, and all-in-one PN supplemented with vitamins and trace elements are stable up until 35, 9, and 7 d, respectively, when protected from light and stored at +2 to 8°C. Also, the supplemented single-chamber PN was found to be stable up to 48 h when stored at +25°C with light exposure. CONCLUSIONS: The results obtained will help improve PN management at the compounding center and in hospital wards, because they allow for the extension of the validity time frame provided so far by the different formulations and, therefore, therapy scheduling over several days.

Pitfalls of iron supplementation in parenteral nutrition admixtures for children with intestinal failure.

BACKGROUND: Pediatric patients with intestinal failure are at increased risk for iron deficiency. Supplementation is not routinely included in parenteral nutrition solutions. There is currently limited research related to the safety of iron supplementation in parenteral nutrition and for intravenous forms used in patients with intestinal failure. Current American Society for Parenteral and Enteral Nutrition and ESPGHAN guidelines promote the use of enteral iron, acknowledging the risks of using iron supplementation within parenteral nutrition admixtures. METHODS: We review a patient case and the current available literature related to iron in parenteral nutrition. RESULTS: Five major concerns are identified: peroxidation reactions, incompatibility, hypersensitivity, infection risk, and iron overload. CONCLUSION: We propose an argument against the preferential use of iron supplementation within parenteral nutrition in children with intestinal failure when enteral supplementation or intermittent parenteral infusion may be sufficient.

[Effectiveness and safety of two lipid emulsions for parenteral nutrition in postsurgical critically ill patients: Clinoleic® versus SMOFlipid®]. / Eficacia y seguridad de dos emulsiones lipídicas de nutrición parenteral en pacientes críticos posquirúrgicos: Clinoleic® frente a SMOFlipid®.

INTRODUCTION: Introduction: a lipid emulsion (LE) may result in different immunomodulatory effects depending on its fatty acid composition. LEs enriched with fish oil and those based on olive oil (OOBE) have shown advantages over those derived from soybean oil, although very few studies have compared these with each other, and none was performed in critically ill surgical patients. Objectives: to demonstrate non-inferiority for the therapeutic efficacy of SMOFlipid® (enriched with fish oil) versus Clinoleic® (OOBE) in relation to the occurrence of nosocomial infection and other evolutionary parameters. To demonstrate non-inferiority in the safety profile of SMOFlipid® versus Clinoleic® in terms of mortality and adverse events. Material and method: a phase-III, non-inferiority clinical trial performed in critically ill postsurgical patients. The subjects were randomized to receive SMOFlipid® or Clinoleic®. For comparison of qualitative variables case frequencies and percentages were obtained using the Chi-squared test or Fisher's exact test. Means were compared between groups using Student's t-test. A p-value lower than 0.05 was considered statistically significant. The Farrington-Manning, Miettinen-Nurminen, and Gart-Nam tests were applied in the main non-inferiority analysis of the primary endpoint. Results: during de inclusion period 73 patients were selected, 37 of whom received Clinoleic® and 36 SMOFlipid®. Regarding the variable "decrease in nosocomial infections", SMOFlipid® proved to be non-inferior to Clinoleic®. Regarding the main variable "mortality", SMOFlipid® proved to be non-inferior to Clinoleic®. There were no statistically significant differences in the occurrence of adverse effects either. Conclusions: in our study, SMOFlipid® proved to be non-inferior to Clinoleic® in terms of efficacy and safety.

INTRODUCCIÓN: Introducción: las emulsiones lipídicas (EL) pueden asociar distintos efectos inmunomoduladores dependiendo de su composición de ácidos grasos. Las EL enriquecidas con aceite de pescado y las basadas en aceite de oliva (EBAO) han mostrado ventajas frente a las derivados del aceite de soja, aunque son muy escasos los estudios que las comparan entre sí y no existe ninguno en pacientes críticos quirúrgicos. Objetivos: Demostrar la no inferioridad de la eficacia terapéutica de SMOFlipid® (enriquecida con aceite de pescado) frente a Clinoleic® (EBAO) en relación con la aparición de infecciones nosocomiales y otros parámetros evolutivos. Demostrar la no inferioridad de la seguridad de SMOFlipid® frente a Clinoleic® expresada como aparición de mortalidad y acontecimientos adversos. Material y método: ensayo clínico de fase III, de no inferioridad, realizado en pacientes críticos posquirúrgicos. Los sujetos se aleatorizaron para recibir SMOFlipid® o Clinoleic®. Para comparar variables cualitativas se obtuvieron la frecuencia y el porcentaje de casos, realizando la prueba del chi cuadrado o el test de Fisher. Las medias entre dos grupos se compararon empleando el test de la "t" de Student. Se consideró estadísticamente significativo un valor de p menor de 0,05. Para el análisis principal de no inferioridad de la variable principal se aplicaron los test de Farrington-Manning, Miettinen-Nurminen y Gart-Nam. Resultados: se incluyeron 73 pacientes, de los cuales 37 recibieron Clinoleic® y 36 SMOFlipid®. En la variable "disminución de infecciones nosocomiales", SMOFlipid® demostró no ser inferior a Clinoleic®. En la variable principal "mortalidad", SMOFlipid® demostró no ser inferior a Clinoleic®. Tampoco existieron diferencias estadísticamente significativas en cuanto a la aparición de efectos adversos. Conclusiones: en nuestro estudio, SMOFlipid® demostró no ser inferior a Clinoleic® en términos de eficacia y seguridad.

Inquérito Brasileiro Sobre Terapia de Nutrição Domiciliar: panorama atual / Brazilian Survey on Home Nutrition Therapy: current overview / Encuesta brasileña sobre terapia nutricional domiciliaria: panorama actual

Objetivo: descrever como a terapêutica nutricional domiciliar é realizada no Programa Melhor em casa do Ministério da Saúde e na Saúde suplementar. Método: Estudo transversal, com dados secundários, onde foram selecionados os perfis de profissionais atuantes em atenção domiciliaria no Brasil. A coleta de dados ocorreu de março a junho de 2018, depois de submetido e aprovado pelo Comitê de Ética e Pesquisa. Resultados: Dos 289 brasileiros, 74% eram profissionais atuantes na Assistência domiciliaria. O tipo de Terapia Nutricional realizada foi 67% enteral exclusiva seguida de 33% terapia mista. A prescrição realizada de dieta exclusiva artesanal foi de 9% e de dieta enteral mista 55%. A maioria recebe dieta por gravidade intermitente, seguida de administração em "bolus", gravitacional contínua e controle do gotejamento através da bomba de infusão. Conclusão: Os achados nos dão uma visão panorâmica da terapia nutricional enteral domiciliar no Brasil. A aumento da terapia nutricional domiciliaria se faz necessária especialmente pelo aumento da população idosa e consequentemente de maior presença das doenças crônicas que podem levar a incapacidade, dependência, maior tempo de hospitalização e custos para o sistema de saúde. É fundamental a presença da equipe interdisciplinar, de boas práticas e do acompanhamento das famílias nos domicílios.

Objective: To learn how home nutritional therapy is carried out in the Ministry of Health's Better Home Program and in Supplementary Health. Method: Cross-sectional study, with secondary data, in which the profiles of professionals working in home care in Brazil were selected. Data collection took place from March to June 2018, after being submitted and approved by the Ethics and Research Committee. Results: Of the 289 Brazilians, 74% were professionals working in home care. The type of nutritional therapy performed was 67% exclusive enteral followed by 33% mixed therapy. The prescription of an exclusive handmade diet was 9% and a mixed enteral diet 55%. Most receive intermittent gravity diet, followed by bolus administration, continuous gravitational and drip control through the infusion pump. Conclusion: The findings give us a panoramic view of home enteral nutritional therapy in Brazil. The increase in home nutritional therapy is necessary especially because of the increase in the elderly population and, consequently, the greater presence of chronic diseases that can lead to disability, dependence, longer hospitalization and costs for the health system. The presence of an interdisciplinary team, good practices and monitoring of families at home is essential.

Objetivo: Conocer cómo se lleva a cabo la terapia nutricional domiciliaria en el Programa Mejor Hogar del Ministerio de Salud y en Salud Complementaria. Método: Estudio transversal, con datos secundarios, en el que se seleccionaron los perfiles de los profesionales que trabajan en la atención domiciliaria en Brasil. La recolección de datos tuvo lugar de marzo a junio de 2018, luego de ser presentados y aprobados por el Comité de Ética e Investigación. Resultados: De los 289 brasileños, el 74% eran profesionales que trabajaban en la atención domiciliaria. El tipo de terapia nutricional realizada fue 67% enteral exclusiva seguida de 33% terapia mixta. La prescripción de una dieta exclusiva artesanal fue del 9% y una dieta enteral mixta del 55%. La mayoría recibe una dieta de gravedad intermitente, seguida de administración de bolo, control gravitacional continuo y de goteo a través de la bomba de infusión. Conclusión: Los hallazgos nos brindan una visión panorámica de la terapia nutricional enteral domiciliaria en Brasil. El aumento de la terapia nutricional domiciliaria es necesario sobre todo por el aumento de la población anciana y, en consecuencia, la mayor presencia de enfermedades crónicas que pueden derivar en discapacidad, dependencia, mayor internación y costos para el sistema de salud. La presencia de un equipo interdisciplinario, buenas prácticas y seguimiento de las familias en el hogar es fundamental.

Stability of N-Acetylcysteine (NAC) in Standardized Pediatric Parenteral Nutrition and Evaluation of N,N-Diacetylcystine (DAC) Formation.

The ESPGHAN/ESPEN/ESPR-Guidelines on pediatric parenteral nutrition (PPN) recommend the administration of the semiessential amino acid (AA) cysteine to preterm neonates due to their biochemical immaturity resulting in an inability to sufficiently synthetize endogenous cysteine. The soluble precursor N-acetylcysteine (NAC) is easily converted into bioavailable cysteine. Its dimer N,N-diacetylcystine (DAC) is almost unconvertable to cysteine when given intravenously resulting in a diminished bioavailability of cysteine. This study aims to understand the triggers and oxidation process of NAC to DAC to evaluate possibilities of reducing DAC formation in standardized PPN. Therefore, different air volumes (21% O2) were injected into the AA compartment of a standardized dual-chamber PPN. O2 concentrations were measured in the AA solution and the headspaces of the primary and secondary packaging. NAC and DAC concentrations were analyzed simultaneously. The analysis showed that O2 is principally delivered from the primary headspace. NAC oxidation exclusively delivers DAC, depending on the O2 amount in the solution and the headspaces. The reaction of NAC to DAC being containable by limiting the O2 concentration, the primary headspace must be minimized during manufacturing, and oxygen absorbers must be added into the secondary packaging for a long-term storage of semipermeable containers.

ASPEN Lipid Injectable Emulsion Safety Recommendations, Part 1: Background and Adult Considerations.

Lipid injectable emulsions (ILEs) are complex pharmaceutical formulations used as a source of energy and essential fatty acids in parenteral nutrition. Issues associated with ILE use are distinctly different from oral fat and arise from emulsion stability, dose, and infusion tolerance. Since 1975, soybean oil has been the consistent source oil used in ILE formulations in the US. Partly because of safety concerns with the soybean-based ILE and frequent and long-standing problems with product inventory shortages, new ILE products have become available. Gaps in ILE best practices create a risk for ILE safety errors in prescribing, compounding, and administration of these products. This paper provides information on appropriate indications, dosing, and methods to avoid potential errors with ILE products in the US. This paper (Part 1) will focus on ILE background, information, and recommendations for adult patients, whereas Part 2 of this series will focus on neonatal and pediatric patient-specific information.

Macronutrients in Parenteral Nutrition: Amino Acids.

The right amount and quality of amino acids (AAs) supplied to patients on parenteral nutrition (PN) reduces muscle mass loss, may preserve or even increase it, with significant clinical benefits. Several industrial PN mixtures are available so that nutrition specialists can choose the product closest to the patient's needs. In selected cases, there is the possibility of personalizing compounded mixtures in a hospital pharmacy that completely meets the individual nutritional needs of PN patients. This narrative review deals with the AA solutions used in PN mixtures. The physiology, the methods to calculate the AA needs, and the AA and energy requirements suggested by scientific guidelines for each patient type are also reported.

Standardised neonatal parenteral nutrition formulations - Australasian neonatal parenteral nutrition consensus update 2017.

BACKGROUND: The first consensus standardised neonatal parenteral nutrition formulations were implemented in many neonatal units in Australia in 2012. The current update involving 49 units from Australia, New Zealand, Singapore, Malaysia and India was conducted between September 2015 and December 2017 with the aim to review and update the 2012 formulations and guidelines. METHODS: A systematic review of available evidence for each parenteral nutrient was undertaken and new standardised formulations and guidelines were developed. RESULTS: Five existing preterm Amino acid-Dextrose formulations have been modified and two new concentrated Amino acid-Dextrose formulations added to optimise amino acid and nutrient intake according to gestation. Organic phosphate has replaced inorganic phosphate allowing for an increase in calcium and phosphate content, and acetate reduced. Lipid emulsions are unchanged, with both SMOFlipid (Fresenius Kabi, Australia) and ClinOleic (Baxter Healthcare, Australia) preparations included. The physicochemical compatibility and stability of all formulations have been tested and confirmed. Guidelines to standardise the parenteral nutrition clinical practice across facilities have also been developed. CONCLUSIONS: The 2017 PN formulations and guidelines developed by the 2017 Neonatal Parenteral Nutrition Consensus Group offer concise and practical instructions to clinicians on how to implement current and up-to-date evidence based PN to the NICU population.

Phytosterolaemia associated with parenteral nutrition administration in adult patients.

Vegetable lipid emulsions (LE) contain non-declared phytosterols (PS). We aimed to determine PS content depending on the brand and LE batch, and in adult hospitalised patients treated with parenteral nutrition (PN), to establish the association between plasma and administered PS. Part I was the LE study: totals and fractions of PS in three to four non-consecutive batches from six LE were analysed. Part II was the patient study: patients with at least 7 previous days of PN with 0·8 g/kg per d of an olive/soyabean (O/S) LE were randomised (day 0) 1:1 to O/S or 100 % fish oil (FO) at a dose of 0·4 g/kg per d for 7 d (day 7). Plasma PS, its fractions, total cholesterol on days 0 and 7, their clearance and their association with PS administered by LE were studied. In part I, LE study: differences were found in the total PS, their fractions and cholesterol among different LE brands and batches. Exclusive soyabean LE had the highest content of PS (422·36 (sd 130·46) µg/ml). In part II, patient study: nineteen patients were included. In the O/S group, PS levels were maintained (1·11 (sd 6·98) µg/ml) from day 0 to 7, while in the FO group, significant decreases were seen in total PS (-6·21 (sd 4·73) µg/ml) and their fractions, except for campesterol and stigmasterol. Plasma PS on day 7 were significantly associated with PS administered (R2 0·443). PS content in different LE brands had great variability. PS administered during PN resulted in accumulation and could be prevented with the exclusive administration of FO LE.

Lipid Emulsion Use in Pediatric Patients Requiring Long-Term Parenteral Nutrition.

The ability to deliver nutrients via parenteral nutrition (PN) has markedly improved the prognosis of infants and children with intestinal failure. Technical refinements and advances in knowledge have led to the development of highly sophisticated PN solutions that are tailored to meet the needs of pediatric patients. However, children who require long-term PN have an increased risk of complications such as catheter-related sepsis, liver disease, and bone disease. Although the pathogenesis of intestinal failure associated liver disease (IFALD) is multifactorial, studies have identified a possible link between the dose of lipid emulsions based on soybean oil and cholestasis, shown to occur with a significantly higher frequency in patients receiving >1 g lipids/kg/d. Potential contributing factors include oxidative stress, high ω-6 polyunsaturated fatty acid (PUFA) and phytosterol content, and relatively low α-tocopherol levels. Lipid emulsions containing fish oil offer potential advantages compared with traditional emulsions with a high soybean oil content, such as decreased ω-6 and increased ω-3 PUFA concentrations, high concentrations of α-tocopherol, and reduced phytosterol content. Studies in PN-dependent children at risk for IFALD have shown that lipid emulsions containing fish oil reduce the risk of cholestasis and improve biochemical measures of hepatobiliary function compared with pure soybean oil emulsions. This review summarizes evidence regarding the role of lipid emulsions in the management of pediatric patients with intestinal failure requiring long-term PN, with a particular focus on the prevention and treatment of IFALD.

Neonatal parenteral nutrition

This guideline covers parenteral nutrition (intravenous feeding) for babies born preterm, up to 28 days after their due birth date and babies born at term, up to 28 days after their birth. Parenteral nutrition is often needed by preterm babies, critically ill babies, and babies who need surgery.

Stability of high-dose thiamine in parenteral nutrition for treatment of patients with Wernicke's encephalopathy.

BACKGROUND & AIMS: Wernicke's encephalopathy is associated mainly with malnourishment in alcohol-dependent patients but can be caused also by cancer, Crohn's disease, gastrointestinal surgery or prolonged parenteral nutrition (PN) without adequate supplementation of vitamins. The disorder, with a significant mortality rate of up to 20%, is often associated with the underlying disease and intensifies after administration of non-supplemented PN. Thus, it seems justified to add thiamine to PN admixtures prepared for parenterally fed patients. Due to the lack of data on the stability of thiamine in PN admixtures at concentrations exceeding 60 mg/L, we decided to determine the possibility of adding a high dose of thiamine (800 mg per bag, 320 mg/L) to PN admixtures in order to treat Wernicke's encephalopathy in malnourished patients. METHODS: The study aimed to assess the stability of the physical properties of PN admixtures (pH, zeta potential, particle size) and to determine thiamine content using an HPLC method. RESULTS: Thiamine was found to degrade regardless of the PN admixture composition and storage conditions. The highest decrease in thiamine content was observed at room temperature without light protection whereas the lowest at a temperature of 4 ± 1 °C with light protection. CONCLUSIONS: The treatment of Wernicke's encephalopathy in parenterally fed patients is possible with the use of high thiamine doses (800 mg) added to PN admixtures without a decrease in the drug content above 10% within the first 24 h. It should be emphasized that thiamine as a photosensitive drug must be stored and administered under conditions ensuring light protection.

Attainment Targets for Protein Intake Using Standardised, Concentrated and Individualised Neonatal Parenteral Nutrition Regimens.

Neonatal parenteral nutrition (NPN) regimens that are individualised (iNPN) or standardised concentrated NPN (scNPN) are both currently used in preterm clinical practice. Two recent trials (one iNPN and one scNPN) each compared standard (control) and high (intervention) parenteral protein and energy dosage regimens and provided data about actual protein intake. We hypothesised that scNPN regimens would achieve a higher percentage of the target parenteral protein intake than their corresponding iNPN regimens. We calculated the daily individual target parenteral protein intake and used the daily parenteral protein intake to calculate the target attainment for protein intake in each infant for the two control (iNPN: n = 59, scNPN: n = 76) and two intervention (iNPN: n = 65; scNPN: n = 74) groups. The median (IQR) target attainment of high-dose protein was 75% (66-85) versus 94% (87-97) on days 1-15 for iNPN and scNPN regimens respectively (p < 0.01). The median (IQR) target attainment of standard dose protein was 77% (67-85) versus 94% (91-96) on days 1-15 for iNPN and scNPN regimens, respectively (p < 0.01). This was associated with improved weight gain (p = 0.050; control groups only) and head growth (p < 0.001; intervention groups only). scNPN regimens have better target attainment for parenteral protein intakes than iNPN regimens.

Quantitative Assessment of Trace-Element Contamination in Parenteral Nutrition Components.

BACKGROUND: Trace-element contamination of contemporary parenteral nutrition (PN) components exists in unknown quantities and, in combination with excessive amounts of certain trace elements provided in commercially available adult, pediatric, and neonatal multitrace-element (MTE) products, could result in eventual accumulation and toxicity. This study aims to quantify trace-element contamination in components used for PN compounding to further inform recommendations for MTE product reformulation and individualized trace-element prescribing in PN. METHODS: A total of 32 unique components (65 products) available for PN compounding were tested for manganese, chromium, selenium, zinc, and copper contamination, utilizing inductively coupled plasma mass spectrometry. Theoretical adult, pediatric, and neonatal PNs were formulated to assess the impact of macronutrient and micronutrient component doses on PN trace-element contamination. RESULTS: Trace-element contamination was detected in 24 (75%) components tested. Chromium and manganese were common, present in 65.6% and 51.5% of all components, respectively. Eight components did not contain detectable trace-element contamination, most notably sterile water, concentrated dextrose, and lipid emulsion. Manganese contamination in theoretical adult, pediatric, and neonatal PN was 25.18, 9.92, and 1.37 µg, respectively. Chromium contamination was 4.85, 1.5, and 0.28 µg, respectively. CONCLUSION: Trace-element contamination was prevalent in components used to compound PN. Our findings support reformulation of adult, pediatric, and neonatal manufactured MTE products to eliminate chromium, decrease manganese, and supply full daily physiologic requirements of selenium, zinc, and copper. Future study is needed to assess the additional contamination that could occur through the compounding and storage processes.

A new alternative for intravenous lipid emulsion 20% w/w from superolein oil and its effect on lipid and liver profiles in an animal model.

PURPOSE: Intravenous lipid emulsion (IVLE) was first used to prevent essential fatty acids deficiency. IVLE with α-tocopherol was reported to provide protection against parenteral nutrition-associated liver disease. This study aims to determine the optimal parameters and conditions in developing a physically stable IVLE from superolein palm oil (SoLE 20%) and its effect on lipid and liver profiles in an animal model. METHODS: SoLE 20% was prepared using superolein oil and MCT oil (1:1), stabilized with egg lecithin and homogenized using a high pressure homogenizer. Mean droplet size was used as the response variable and was measured using laser diffraction and dynamic light scattering method. Physical stability at 4 °C, 25 °C and 40 °C storage temperatures were determined based on particle size and distribution, polydispersity index, zeta potential, viscosity, vitamin E contents and pH. Sterility and pyrogenicity were also investigated. Rabbits were administered with 1.0 g/kg SoLE 20% for 5 h and repeated daily for 3 days to investigate its effect on blood lipid and liver enzymes profile. RESULTS: SoLE 20% was succesfully prepared using the optimized parameters of 800 psi, 7 cycles and 1.2 g lecithin. The IVLE prepared had a particle size of 252.60 ± 4.88 nm and was physically stable for 4 weeks at different storage temperatures. SoLE 20% had a high content of natural vitamin E, remained sterile and pyrogen free. It was also safe for intravenous administration and did not alter the blood lipid (p > 0.05) and liver enzymes profiles (p > 0.05) of the rabbits. CONCLUSION: The optimal parameters to develop a stable superolein based IVLE are 800 psi homogenization pressure, 7 homogenization cycles and using 1.2 g lecithin as the emulsifier. SoLE 20% is safe for intravenous administration and does not significantly alter lipid and liver enzymes profiles of the rabbits.

Modifying Serum Plant Sterol Concentrations: Effects on Markers for Whole Body Cholesterol Metabolism in Children Receiving Parenteral Nutrition and Intravenous Lipids.

BACKGROUND: Non-cholesterol sterols are validated markers for fractional intestinal cholesterol absorption (cholestanol) and endogenous cholesterol synthesis (lathosterol). This study's objective was to evaluate markers for cholesterol synthesis and absorption in children exposed to two different intravenous lipid emulsions that rapidly change serum plant sterol concentrations as part of their parenteral nutrition (PN). METHODS: Serum samples from two different studies were used: (1) nine PN-dependent children with intestinal failure associated liver disease (IFALD) whose soy-based, plant sterol-rich lipid (SO) was replaced with a fish-based, plant sterol-poor (FO) lipid; and (2) five neonates prescribed SO after birth. In the first study, samples were collected at baseline (prior to FO initiation) and after 3 and 6 months of FO. In study 2, samples were collected at 1 and 3 weeks of age. RESULTS: In study 1, a 7-fold reduction in campesterol, a 12-fold reduction in sitosterol, and a 15-fold reduction in stigmasterol was observed 6 months after switching to FO. Serum cholesterol concentrations did not change, but cholesterol-standardized lathosterol increased (3-fold) and cholesterol-standardized cholestanol decreased (2-fold). In study 2, after 3 weeks of SO, sitosterol and campesterol concentrations increased 4-5 fold. At the same time, cholesterol-standardized lathosterol increased 69% and cholesterol-standardized cholestanol decreased by 29%. CONCLUSION: Based on these finding we conclude that changes in serum plant sterol concentrations might have direct effects on endogenous cholesterol synthesis, although this needs to be confirmed in future studies. Moreover, we speculate that this changed synthesis subsequently affects intestinal cholesterol absorption.

Aluminum toxicity to bone: A multisystem effect?

Aluminum (Al) is the third most abundant element in the earth's crust and is omnipresent in our environment, including our food. However, with normal renal function, oral and enteral ingestion of substances contaminated with Al, such as antacids and infant formulae, do not cause problems. The intestine, skin, and respiratory tract are barriers to Al entry into the blood. However, contamination of fluids given parenterally, such as parenteral nutrition solutions, or hemodialysis, peritoneal dialysis or even oral Al-containing substances to patients with impaired renal function could result in accumulation in bone, parathyroids, liver, spleen, and kidney. The toxic effects of Al to the skeleton include fractures accompanying a painful osteomalacia, hypoparathyroidism, microcytic anemia, cholestatic hepatotoxicity, and suppression of the renal enzyme 25-hydroxyvitamin D-1 alpha hydroxylase. The sources of Al include contamination of calcium and phosphate salts, albumin and heparin. Contamination occurs either from inability to remove the naturally accumulating Al or from leeching from glass columns used in compound purification processes. Awareness of this long-standing problem should allow physicians to choose pharmaceutical products with lower quantities of Al listed on the label as long as this practice is mandated by specific national drug regulatory agencies.

[Precipitation limits in pediatric parenteral nutritions with organic sources of calcium and phosphate]. / Límites de precipitación en nutriciones parenterales pediátricas con fuentes de calcio y fosfato orgánicas.

OBJECTIVE: to determine if precipitation processes occur in parenteral nutrition solutions (PNs) with calcium gluconate and sodium glycerophosphate in the precipitation threshold limits of the Spanish SENPE/SEGHNP/SEFH 2008 consensus document of PN preparation. METHODS: seven PNs with different composition were prepared in triplicate: five 100 ml PNs with different concentrations of amino acids, calcium and phosphorus similar to consensus document maximum concentrations for precipitation, and two control PNs: one without calcium and phosphorus and other with high calcium and phosphorus content and low concentration of amino acids. All PNs did not contain lipids to allow correct detection of precipitates. The no lipid PNs were stored at room temperature for 20 hours, and at 35 °C for four hours. Subsequently, they filtered through a 0.2 µm filter, which was observed by electron microscopy. Because a large amount of not expected precipitates was observed, complementary studies were carried out. RESULTS: precipitates were observed in all PNs except in the control solution without calcium and phosphorus; many of them were greater than 10 µm. However, according to our studies, these crystals were produced after filtration and calcium was found in their composition, but not phosphorus. Particles from the preparation of parenteral nutrition were also observed. CONCLUSIONS: in our study we did not find calcium phosphate precipitates in the limits included in the consensus document SENPE/SEGHNP/ SEFH. However, it is possible that micro precipitates with calcium are formed. It is important to filter PNs prior to their administration.

OBJETIVO: conocer si hay precipitación en nutriciones parenterales (NP) con gluconato cálcico y glicerofosfato sódico en las cantidades límites del documento de consenso español de preparación de nutrición parenteral SENPE/SEGHNP/SEFH 2008. MÉTODOS: se prepararon por triplicado siete NP: cinco de 100 ml con concentraciones de aminoácidos, calcio y fósforo similares a las concentracionesmáximas de precipitación del documento consenso SENPE/SEGHNP/SEFH y dos controles, uno sin calcio y fósforo y otro con alto contenido de calcio y fósforo y baja concentración de aminoácidos. Las NP no contenían lípidos. Las NP se almacenaron 20 horas a temperatura ambiente y cuatro horas a 35 °C, y se filtraron con un filtro de 0,2 micras. Estos filtros se transportaron y observaron parcialmente por microscopía electrónica. Los cristales observados se analizaron por espectrometría por dispersión de rayos X a 1.000 aumentos. Al observarse gran cantidad de precipitados, que no se correspondían a los estudios publicados, se realizaron estudios complementarios para conocer su origen. RESULTADOS: en todos los casos, a excepción del control sin calcio y fósforo, se observaron precipitados. Sin embargo, estos cristales, según nuestros estudios, se produjeron después de la filtración y en su composición está el calcio, pero no el fósforo. También se observaron partículas provenientes de la preparación de nutrición parenteral. CONCLUSIONES: en nuestro estudio no encontramos precipitados de fosfato cálcico en los límites recogidos en el documento consenso SENPE/SEGHNP/SEFH. Sin embargo, es posible que se formen microprecipitados con calcio en su composición. Es importante fi ltrar las NP previamente a su administración.