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.

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.

Effects of a novel method for enteral nutrition infusion involving a viscosity-regulating pectin solution: A multicenter randomized controlled trial.

BACKGROUND & AIMS: The initial complications associated with infusion of enteral nutrition (EN) for clinical and nutritional care are vomiting, aspiration pneumonia, and diarrhea. There are many recommendations to prevent these complications. A novel method involving a viscosity-regulating pectin solution has been demonstrated. In Japan, this method along with the other so-called "semi-solid EN" approaches has been widely used in practice. However, there has been no randomized clinical trial to prove the efficiency and safety of a viscosity-regulating pectin solution in EN management. Therefore, we planned and initiated a multicenter randomized controlled trial to determine the efficiency and safety. METHODS: This study included 34 patients from 7 medical institutions who participated. Institutional review board (IRB) approval was obtained from all participating institutions. Patients who required EN management were enrolled and randomly assigned to the viscosity regulation of enteral feeding (VREF) group and control group. The VREF group (n = 15) was managed with the addition of a viscosity-regulating pectin solution. The control group (n = 12) was managed with conventional EN administration, usually in a gradual step-up method. Daily clinical symptoms of pneumonia, fever, vomiting, and diarrhea; defecation frequency; and stool form were observed in the 2 week trial period. The dose of EN and duration of infusion were also examined. RESULTS: A favorable trend for clinical symptoms was noticed in the VREF group. No significant differences were observed in episodes of pneumonia, fever, vomiting, and diarrhea between the 2 groups. An apparent reduction in infusion duration and hardening of stool form were noted in the VREF group. CONCLUSIONS: The novel method involving a viscosity-regulating pectin solution with EN administration can be clinically performed safely and efficiently, similar to the conventional method. Moreover, there were benefits, such as improvement in stool form, a short time for EN infusion, and a reduction in vomiting episodes, with the use of the novel method. This indicates some potential advantages in the quality of life among patients receiving this novel method.

Glutamine dipeptide-supplemented parenteral nutrition improves the clinical outcomes of critically ill patients: A systematic evaluation of randomised controlled trials.

BACKGROUND & AIMS: Early randomised controlled trials (RCTs) testing whether parenteral nutrition regimens that include glutamine dipeptides improves the outcomes of critically ill patients demonstrated convincingly that this regimen associates with reduced mortality, infections, and hospital stays. However, several new RCTs on the same question challenged this. To resolve this controversy, the present meta-analysis was performed. Stringent eligibility criteria were used to select only those RCTs that tested the outcomes of critically ill adult patients without hepatic and/or renal failure who were haemodynamically and metabolically stabilised and who were administered glutamine dipeptide strictly according to current clinical guidelines (via the parenteral route at 0.3-0.5 g/kg/day; max. 30% of the prescribed nitrogen supply) in combination with adequate nutrition. METHODS: The literature research (PubMed, Embase, Cochrane Central Register of Controlled Trials) searched for English and German articles that had been published in peer-review journals (last entry March 31, 2015) and reported the results of RCTs in critically ill adult patients (major surgery, trauma, infection, or organ failure) who received parenteral glutamine dipeptide as part of an isoenergetic and isonitrogenous nutrition therapy. The following data were extracted: infectious complications, lengths of stay (LOS) in the hospital and intensive care unit (ICU), duration of mechanical ventilation, days on inotropic support, and ICU and hospital mortality rates. The selection of and data extraction from studies were performed by two independent reviewers. RESULTS: Fifteen RCTs (16 publications) fulfilled all selection criteria. They involved 842 critically ill patients. None had renal and/or hepatic failure. The average study quality (Jadad score: 3.8 points) was well above the predefined cut-off of 3.0. Common effect estimates indicated that parenteral glutamine dipeptide supplementation significantly reduced infectious complications (relative risk [RR] = 0.70, 95% CI 0.60, 0.83, p < 0.0001), ICU LOS (common mean difference [MD] -1.61 days, 95% CI -3.17, -0.05, p = 0.04), hospital LOS (MD -2.30 days, 95% CI -4.14, -0.45, p = 0.01), and mechanical ventilation duration (MD -1.56 days, 95% CI -2.88, -0.24, p = 0.02). It also lowered the hospital mortality rate by 45% (RR = 0.55, 95% CI 0.32, 0.94, p = 0.03) but had no effect on ICU mortality. Visual inspection of funnel plots did not reveal any potential selective reporting of studies. CONCLUSIONS: This meta-analysis clearly confirms that when critically ill patients are supplemented with parenteral glutamine dipeptide according to clinical guidelines as part of a balanced nutrition regimen, it significantly reduces hospital mortality, infectious complication rates, and hospital LOS. The latter two effects indicate that glutamine dipeptide supplementation also confers economic benefits in this setting. The present analysis indicates the importance of delivering glutamine dipeptides together with adequate parenteral energy and nitrogen so that the administered glutamine serves as precursor in various biosynthetic pathways rather than simply as a fuel.

Independence From Parenteral Nutrition and Intravenous Fluid Support During Treatment With Teduglutide Among Patients With Intestinal Failure Associated With Short Bowel Syndrome.

BACKGROUND: In phase III clinical studies, treatment with teduglutide was associated with clinically meaningful reductions (≥20% from baseline) in parenteral support (PS; parenteral nutrition and/or intravenous fluids) requirements in adult patients with intestinal failure associated with short bowel syndrome (SBS-IF). This analysis reports clinical characteristics of patients who achieved complete independence from PS during teduglutide treatment. MATERIALS AND METHODS: Post hoc analysis of adult patients who achieved complete PS independence during treatment with teduglutide 0.05 mg/kg/d. Data were pooled from 5 teduglutide clinical trials (2 phase III placebo-controlled trials [NCT00081458 and NCT00798967] and their respective extension studies [NCT00172185, NCT00930644, NCT01560403]). Descriptive statistics were used; no between-group comparisons were performed because of the small sample size and lack of comparator. RESULTS: Of 134 patients, 16 gained oral or enteral autonomy after a median of 5 years of PS dependence and 89 weeks of teduglutide treatment. Demographic and baseline disease characteristics varied among patients (median age, 55 years; 50% men; median baseline PS volume, 5.1 L/wk; median residual small intestine length, 52.5 cm). Most patients who achieved PS independence had colon-in-continuity; however, there was no significant difference in the frequency of PS independence among patients who maintained colon-in-continuity vs those who did not. CONCLUSION: Findings from this post hoc analysis suggest that oral or enteral autonomy is possible for some patients with SBS-IF who are treated with teduglutide, regardless of baseline characteristics and despite long-term PS dependence.

The study of early intravenous nutrition therapy in very low birth weight infants.

To analyze the clinical effect of early intravenous nutrition therapy for very low birth weight infants. 80 cases of very low birth weight infants referred to our hospital from June 2013 to June 2015 were randomly and evenly divided into two groups. The infants in group A were treated with early intravenous nutrition, while with late parenteral nutrition for those in group B. The intravenous nutrition time, proportion of body weight loss, time consumption for recovery to birth weight and full enteral nutrition and complication rate between the two groups were compared. We found that there were significant differences in the intravenous nutrition time, proportion of body weight loss, and time consumption for recovery to birth weight and full enteral nutrition between the two groups (P<0.05). Moreover, the complication rate of group A was 7.5%, which was 17.5% lower comparing with 25.0% in group B (P<0.05). Thus, we conclude that early intravenous nutrition therapy in very low birth weight infants is effective and safe and further promotion and application of this therapy is worthy.

Clinical Experience With Numeta in Preterm Infants: Impact on Nutrient Intake and Costs.

BACKGROUND: A new "ready-to-use" triple-chamber container, Numeta (Baxter, Deerfield, IL), is available for preterm parenteral nutrition (PN) to provide nutrients according to the recommendations of the European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) and the European Society for Clinical Nutrition and Metabolism (ESPEN) Guidelines for Pediatric Parenteral Nutrition. We investigated the clinical application of Numeta compared with individualized PN in preterm infants (≤1.500 g) and evaluated the effects on nutrient intake, costs, and preparation time. MATERIALS AND METHODS: In a clinical observational study, prescriptions for preterm infants were performed with the new prescription software catoPAN (Cato Software Solutions, Becton Dickinson, Vienna, Austria). Individualized PN and Numeta prescriptions were mirrored, and nutrition content of the PNs was compared with each other and with ESPGHAN/ESPEN recommendations. Furthermore, costs and preparation time were assessed. RESULTS: In total, 374 PN solutions (>1000 g [n = 333]/≤1000 g [n = 41]) were analyzed. Protein intake with Numeta was significantly lower compared with individualized PN and did not meet the recommendations for infants <1500 g during the first day and the period of transition after birth. Energy intake was significantly higher with Numeta. The costs for Numeta preparations were €18 (about US$20) higher than for individualized PN. However, the preparation time/solution was 2 minutes faster with Numeta. CONCLUSION: Numeta is an alternative to individualized PN for infants >1000 g in the period of stable growth when enteral feedings have already started. Protein intake is significantly lower than in individualized PN solutions. Numeta is more expensive in comparison to individualized PN but saves human resources.

Effects of different parenteral nutrition infusions in a patient with short bowel syndrome.

In this case study, we demonstrate the effects of different lipid emulsions on liver function in a 52-year-old woman with short bowel syndrome who was totally dependent on parenteral nutrition. Over a 13-month period after small bowel resection and jejunostomy, we followed the patient's plasma triglycerides and liver enzyme levels as well as body weight and discomfort levels. During the first 3 months when parenteral nutrition including a lipid emulsion containing 50% soybean oil/50% medium-chain triglyerides was administered daily, the patient reported feeling unwell (experiencing dizziness and palpitations) and her triglycerides and liver enzyme levels rose to 366 mg/dL and 145 U/L (alanine aminotransferase [ALT]), respectively; these levels recovered when this emulsion was discontinued. For the following 9 months, an emulsion containing 80% olive oil and 20% soybean oil was administered, and the patient's triglycerides (182 mg/dL) did not increase to abnormal levels and liver enzyme levels were only mildly elevated (109 U/L). The patient felt well and her body weight increased from 51 kg to 55 kg during this period. These results suggest that parenteral nutrition with a reduced soybean oil content may better preserve liver function in patients with short bowel syndrome.

Higher docosahexaenoic acid, lower arachidonic acid and reduced lipid tolerance with high doses of a lipid emulsion containing 15% fish oil: a randomized clinical trial.

BACKGROUND & AIMS: Lipid emulsions containing fish oil, as source of long chain omega 3 fatty acids, have recently became available for parenteral nutrition in infants, but scanty data exist in extremely low birth weight preterms. The objective of this study was to compare plasma fatty acids and lipid tolerance in preterm infants receiving different doses of a 15% fish oil vs. a soybean oil based lipid emulsion. METHODS: Preterm infants (birth weight 500-1249 g) were randomized to receive parenteral nutrition with MOSF (30% Medium-chain triglycerides, 25% Olive oil, 30% Soybean oil, 15% Fish oil) or S (S, 100% Soybean oil) both at two levels of fat intake: 2.5 or 3.5 g kg(-1) d(-1), named 2.5Fat and 3.5Fat respectively. Plasma lipid classes and their fatty acid composition were determined on postnatal day 7 and 14 by gas chromatography together with routine biochemistry. RESULTS: We studied 80 infants. MOSF infants had significantly higher plasma phospholipid Docosahexaenoic acid and Eicosapentaenoic and lower Arachidonic acid. Plasma phospholipids, triglycerides and free cholesterol were all significantly higher in the MOSF-3.5Fat group, while cholesterol esters were lower with MOSF than with S. The area under the curve of total bilirubin was significantly lower with MOSF than with S. CONCLUSIONS: The use of a lipid emulsion with 15% FO resulted in marked changes of plasma long-chain fatty acids. Whether the benefits of increasing Docosahexaenoic acid outweigh the potential negative effect of reduced Arachidonic acid should be further studied. MOSF patients exhibited reduced lipid tolerance at 3.5 g kg(-1) d(-1) fat intake. The trial was conducted between January 2008 and December 2012 so we had not registered it in a public trials registry as it is now required for trials that started after July 2008.

Zinc deficiency in a parenteral nutrition-dependent patient during a parenteral trace element product shortage.

Parenteral nutrition product shortages are common and place vulnerable patients at risk for nutrient deficiencies. This case report describes a parenteral nutrition-dependent patient who was found to have zinc deficiency during a parenteral nutrition product shortage. The management of the patient's zinc deficiency is described.

Effects of parenteral nutrition formulas on plasma lipid profile in children with bone marrow transplantation.

BACKGROUND/AIMS: Children undergoing bone marrow transplantation (BMT) often require parenteral nutrition (PN). This is a comparative study of plasma lipid profiles in BMT children after fish oil or soybean PN. METHODS: A total of 14 children with BMT requiring PN for at least 10 days were recruited during 24 months. They were randomized to receive a lipid emulsion enriched with ω3 polyunsaturated fatty acid, or soybean oil. Clinical monitoring was performed. Blood samples were collected before and after administration of PN to analyze the lipid profile. RESULTS: There were no complications associated with PN. The increase in TG levels was more pronounced after administration of an enriched ω3 emulsion and the decrease in cHDL and apo A was greater after administration of soybean. The ω3 group showed an increase in eicosapentaenoic and a decrease in arachidonic acids compared to the soybean group. Both groups showed similar levels of linolenic acid. CONCLUSION: PN with soybean or ω3 emulsions for 10 days is safe in children. However, research in children are necessary in order to examine the impact of the duration of PN and the type of lipid formula used, and determine their health benefits in relation to the fatty acid profile.

Lipid emulsions in parenteral nutrition: current applications and future developments.

INTRODUCTION: A parenteral lipid emulsion (LE), used as a key source of energy, essential fatty acids (FAs), and fat-soluble vitamins, is an integral part of a parenteral nutrition (PN) regimen. The conventional LEs, such as soybean oil (SO)-based emulsions, have caused concerns about the potential adverse effects involving oxidative stress, inflammation, and immune response probably because of undesirable FA composition. AREAS COVERED: Recently, alternative LEs, optimizing the FA composition with partial substitution of SO with medium-chain triglyceride (MCT), olive oil (OO), and fish oil (FO), have been developed and applied in clinical practice. This review summarizes the characteristics and beneficial clinical effects of alternative parenteral LEs in critically ill, pediatric, and long-term PN patients. EXPERT OPINION: More clinical data from sufficiently high-powered studies are required to characterize the integral biological properties of alternative LEs for further selection to fit individual needs and disease characteristics. Simultaneously, potential lipid sources with desirable FA compositions and biological properties should be selected to develop new therapeutic LEs. As supplements to current parenteral lipids, the new LEs with different therapeutic effects are expected to fit specified subpopulations of patients with different diseases. Great efforts should be devoted to the development of parenteral LEs.

Safety and efficacy of early parenteral lipid and high-dose amino acid administration to very low birth weight infants.

OBJECTIVE: To assess the efficacy and safety of early parenteral lipid and high-dose amino acid (AA) administration from birth onwards in very low birth weight (VLBW, birth weight <1500 g) infants. STUDY DESIGN: VLBW infants (n = 144; birth weight 862 ± 218 g; gestational age 27.4 ± 2.2 weeks) were randomized to receive 2.4 g of AA kg(-1) · d(-1) (control group), or 2.4 g AA kg(-1) · d(-1) plus 2-3 g lipids kg(-1) · d(-1) (AA + lipid group), or 3.6 g AA kg(-1) · d(-1) plus 2-3 g lipids kg(-1) · d(-1) (high AA + lipid group) from birth onwards. The primary outcome was nitrogen balance. The secondary outcomes were biochemical variables, urea rate of appearance, growth rates, and clinical outcome. RESULTS: The nitrogen balance on day 2 was significantly greater in both intervention groups compared with the control group. Greater amounts of AA administration did not further improve nitrogen balance compared with standard AA dose plus lipids and was associated with high plasma urea concentrations and high rates of urea appearance. No differences in other biochemical variables, growth, or clinical outcomes were observed. CONCLUSIONS: In VLBW infants, the administration of parenteral AA combined with lipids from birth onwards improved conditions for anabolism and growth, as shown by improved nitrogen balance. Greater levels of AA administration did not further improve the nitrogen balance but led to increased AA oxidation. Early lipid initiation and high-dose AA were well tolerated.

Clinical experience with a lipid-free, ready-made parenteral nutrition solution in dogs: 70 cases (2006-2012).

OBJECTIVE: To review the clinical use of a lipid-free, ready-made amino acid and glucose parenteral nutrition (PN) solution in dogs. DESIGN: Retrospective study of dogs from 2006 to 2012 that received this form of PN. SETTING: University veterinary teaching hospital. ANIMALS: Seventy dogs presented to the hospital for treatment of various diseases in which PN was used as part of patient management. Dogs were administered PN at the discretion of the primary clinician. INTERVENTION: A lipid-free, ready-made solution containing amino acid (59 g/L) and dextrose (100 g/L) was administered intravenously as a constant rate infusion to provide nutritional support. MEASUREMENTS AND MAIN RESULTS: PN was provided for a median of 2.2 days (range 0.5-9.5 days) in the 70 dogs, totaling 168 days of PN. The PN provided a median of 5.5 g/100 kcal of protein (range 1-9.5 g/100 kcal) and a median of 2.2 mg/kg of bodyweight per minute (range 0.8-5.2 mg/kg/min) of glucose, which reflected a median of 57% of the resting energy requirement (range 9-100%). Metabolic complications developed in 43 of 67 dogs where these data were recorded, but the development of hyperkalemia was the only complication associated with a poor outcome (eg, death or euthanasia). Mechanical complications were seen in 28 dogs, and all but one of these occurred when PN was delivered through peripheral catheters. Septic complications were confirmed in 5 dogs. CONCLUSIONS: This form of PN is suitable for clinical use and can provide both protein and calories to ill dogs. It was, however, associated with a high rate of complications and requires careful patient monitoring.

Four-week parenteral nutrition using a third generation lipid emulsion (SMOFlipid)--a double-blind, randomised, multicentre study in adults.

PRECIS: The aim of this study was to evaluate the safety and tolerance of a soybean/MCT/olive/fish oil emulsion in intestinal failure patients on long-term parenteral nutrition. 73 patients took part in a randomized, double-blind, multi-centre study. The study demonstrates that the lipid emulsion containing four different types of oils is safe and well tolerated in long-term PN. BACKGROUND & AIM: Long-term safety and efficacy of a lipid emulsion containing soybean oil, medium-chain triglycerides (MCT), olive oil and fish oil and enriched in vitamin E have not yet been evaluated in adult patients requiring long-term parenteral nutrition (PN). METHODS: Randomised, controlled, double-blind, multicentre study in 73 patients with stable intestinal failure, requiring PN with either soybean/MCT/olive/fish emulsion (SMOFlipid, n = 34) or soybean emulsion (Intralipid, control n = 39) for 4 weeks. Safety and tolerance were monitored with standard clinical laboratory parameters, adverse events (AEs, according to the Common Terminology Criteria for Adverse Events (CTCAE) classification v 3.0) and vital signs. Fatty acid pattern in red blood cell phospholipids and plasma lipoproteins, serum Vitamin E, Interleukin (IL)-6, and soluble tumour necrosis (s-TNF)-receptor(R)II were also evaluated. RESULTS: Mean concentrations of alanine transaminase (ALT), aspartate transaminase (AST) and total bilirubin, whilst remaining within the reference range, were significantly lower with soybean/MCT/olive/fish (SMOF) oil emulsion after the treatment period compared to control. Eicosapentaenoic acid, docosahexaenoic acid and n-3/n-6 fatty acid ratio increased in the SMOF group, while they remained unchanged in the control in plasma and RBC. Serum α-tocopherol concentrations significantly increased in the study group compared to control (p = 0.0004). IL-6 and sTNF-RII levels did not change during the study period. Grade 4 (serious) adverse events occurred in 2 SMOF patients and in 8 control patients (p = 0.03). CONCLUSIONS: Soybean/MCT/olive/fish emulsion was safe and well tolerated over 4 weeks and leads to positive change in fatty acids profile.

Management of copper deficiency in cholestatic infants: review of the literature and a case series.

Copper is an essential trace element, playing a critical role in multiple functions in the body. Despite the necessity of adequate copper provision and data supporting the safety of copper administration during cholestasis, it remains common practice to reduce or remove copper in parenteral nutrition (PN) solutions after the development of cholestasis due to historical recommendations supporting this practice. In neonates, specifically premature infants, less is known about required copper intakes to accumulate copper stores and meet increased demands during rapid growth. Pediatric surgical patients are at high risk for hepatic injury during long-term PN provision and a balance is needed between the potential for reduced biliary excretion of copper and adequate copper intakes to prevent deficiency. Copper deficiency has been documented in several pediatric patients with cholestasis when parenteral copper was reduced or removed. Few data guide the management of copper deficiency in the pediatric population. The following case series describes our experience with successfully managing copper deficiency in 3 cholestatic infants after copper had been reduced or removed from their PN. Classic signs of copper deficiency were present, including hypocupremia, anemia, neutropenia, thrombocytopenia, and osteopenia. Treatment included use of both parenteral and enteral copper supplementation. We suggest revision of current recommendations regarding decreasing copper in PN during cholestasis with a proposed algorithm for parenteral copper provision in the setting of cholestasis that is based on evaluation of measured serum copper concentrations.

The mode of administration of total parenteral nutrition and nature of lipid content influence the generation of peroxides and aldehydes.

BACKGROUND & AIMS: The absence of light protection of neonatal total parenteral nutrition (PN) contributes to the generation of 4-hydroxynonenal and peroxides. 4-Hydroxynonenal is suspected to be involved in PN-related liver complications. AIMS: To find a practical modality to reduce 4-hydroxynonenal in PN and assess in vivo the impact of PN containing low 4-hydroxynonenal concentration. METHODS: Six modalities of delivering PN were compared for the in vitro generation of peroxides and 4-hydroxynonenal: 1) MV-AA-L: light-protected (-L) solution containing multivitamin (MV) mixed with amino acids + dextrose (AA); 2) MV-AA+L: MV-AA without photo-protection (+L); 3) MV-LIP+L: MV mixed with lipid emulsion (LIP). LIP was a) Intralipid20%(®) or b) Omegaven(®). Hepatic markers of oxidative stress (glutathione, F(2α)-isoprostanes, GS-HNE) and inflammation (mRNA of TNF-α and IL-1) were measured in newborn guinea pigs infused during 4-days with MV-AA+L compounded with Intralipid20%(®) or Omegaven(®). RESULTS: Hydroperoxides and 4-hydroxynonenal were the lowest in MV-AA-L and the highest in MV-LIP+L. MV-AA+L with Omegaven(®) was associated with the lowest levels of markers of oxidative stress and inflammation. CONCLUSION: Compared to Intralipid20%(®), Omegaven(®) reduces oxidative stress associated with PN and prevents liver inflammation. These findings offer an alternative strategy to light protection of PN, which in the clinical setting is a cumbersome modality.

Improved outcome in neonatal short bowel syndrome using parenteral fish oil in combination with ω-6/9 lipid emulsions.

BACKGROUND: Newborn infants with short bowel syndrome (SBS) represent a high-risk group of developing intestinal failure-associated liver disease (IFALD), which may be fatal. However, infants have a great capacity for intestinal growth and adaptation if IFALD can be prevented or reversed. A major contributing factor to IFALD may be the soybean oil-based intravenous lipid emulsions used since the introduction of parenteral nutrition (PN) 40 years ago. METHODS: This retrospective study compares the outcome in 20 neonates with SBS treated with parenteral fish oil (Omegaven) in combination with ω-6/9 lipid emulsions (ClinOleic) with the outcome in a historical cohort of 18 patients with SBS who received a soybean oil-based intravenous lipid emulsion (Intralipid). RESULTS: Median gestational age was 26 weeks in the treatment group and 35.5 weeks in the historical group. All patients were started on PN containing Intralipid that was switched to ClinOleic/Omegaven in the treatment group at a median age of 39 gestational weeks. In the treatment group, direct bilirubin levels were reversed in all 14 survivors with cholestasis (direct bilirubin >50 umol/L). Median time to reversal was 2.9 months. Only 2 patients died of liver failure (10%). In the historical cohort, 6 patients (33%) died of liver failure, and only 2 patients showed normalization of bilirubin levels. CONCLUSIONS: Parenteral fish oil in combination with ω-6/9 lipid emulsions was associated with improved outcome in premature neonates with SBS. When used instead of traditional soybean-based emulsions, this mixed lipid emulsion may facilitate intestinal adaptation by increasing the IFALD-free period.

Benefits of a new pediatric triple-chamber bag for parenteral nutrition in preterm infants.

OBJECTIVES: The aim of this study was to evaluate the efficacy, safety, flexibility, and ease of handling and use of the Ped3CB-A 300  mL, the first ready-to-use multichamber parenteral nutrition (PN) system, with optional lipid bag activation, specially designed for administration to preterm infants. MATERIALS AND METHODS: In this prospective, open-label, multicenter, noncomparative, phase III clinical trial, preterm infants were treated with Ped3CB-A for 5 to 10 consecutive days. RESULTS: A total of 113 preterm infants were enrolled in the study and 97 (birth weight 1382 ±â€Š520 g; gestational age 31.2 ±â€Š2.5 weeks; postnatal age administration 5.6 ±â€Š6.1 days) were included in the per protocol analysis accounting for 854 perfusion days. Double-chamber bag activation was used for 32 perfusion days. Macronutrient, electrolyte, and mineral supplements were primarily administered through a Y-line or directly in the activated bag. In all, 199 additions (mainly sodium, 95%) were made to the Ped3CB-A bags on 197 infusion days (23.1%) in 43 infants (44.3%). More than 1 of these nutrients was added to the bag on only 1 perfusion day. Mean and maximum parenteral nutrient intakes were 2.8 ±â€Š0.7 and 3.6 ±â€Š0.8  g amino acids per kilogram per day, and 80 ±â€Š20 and 104 ±â€Š22  kcal · kg(-1) · day(-1). Mean weight gain represented 10.0, 21.5, and 22. 6 g · kg(-1) · day(-1) according to age at inclusion (0-3, 4-7, or >7 days of life). A visual analog scale was completed and produced positive results. No adverse events were attributable to the design of the Ped3CB-A system. CONCLUSIONS: Ped3CB-A provides easy-to-use, well-balanced, and safe nutritional support. Nutritional intakes and weight gain were within the recent PN recommendations in preterm infants.

Bloodstream infections in patients receiving manufactured parenteral nutrition with vs without lipids: is the use of lipids really deleterious?

BACKGROUND: This study compared overall bacterial and bloodstream infection rates in patients receiving premixed parenteral nutrition (PN) with vs without lipid emulsion. METHODS: Data from hospitalized patients who were ≥18 years of age and receiving premixed PN between 2005 and 2007 were extracted from the Premier Perspective database. Data were categorized into 2 groups: patients who received premixed PN only and those receiving premixed PN with lipids. Multiple logistic regression was used to adjust for risk factors and potential confounders, reporting the probability of risk for an infection. RESULTS: The group without lipids was observed to have lower rates of both overall bacterial infection (43.5% vs 53.5%) and bloodstream infection (14.5% vs 18.9%). However, after adjusting for baseline characteristics, there were no significant differences in overall risk of bacterial infections (51.4% vs 53.5%; odds ratio [OR] = 1.11; 95% confidence interval [CI], 0.96-1.27) or bloodstream infections (19.6% vs 19.2%; 0.97; 0.81-1.16). In a subset of patients in the intensive care unit for ≥3 days, lower overall bacterial infection rates (58.3% vs 67.3%) and bloodstream infection rates (31.0% vs 37.0%) were observed in the group without lipids. After adjustment, there were no significant differences in risk of overall bacterial infection (OR = 0.95; 95% CI, 0.75-1.22) or bloodstream infection (0.92; 0.71-1.19) between the 2 groups. CONCLUSIONS: When administered with premixed PN, lipid emulsion was not significantly associated with an increase in the risk of infectious morbidity when compared to omitting lipids from therapy.