ASPEN definitions in pediatric intestinal failure.

Pediatric intestinal failure (PIF) is a relatively rare disease entity that requires focused interdisciplinary care and specialized nutrition management. There has long been a lack of consensus in the definition of key terms related to PIF because of its rarity and a plethora of small studies rather than large trials. As such, the American Society for Parenteral and Enteral Nutrition (ASPEN) PIF Section, composed of clinicians from a variety of disciplines caring for children with intestinal failure, is uniquely poised to provide insight into this definition void. This document is the product of an effort by the Section to create evidence-based consensus definitions, with the goal of allowing for appropriate comparisons between clinical studies and measurement of long-term patient outcomes. This paper has been approved by the ASPEN Board of Directors.

ASPEN lipid injectable emulsion safety recommendations part 2: Neonate and pediatric considerations.

Lipid injectable emulsions (ILEs) are complex pharmaceutical formulations intended as a source of energy and fatty acids for parenteral nutrition (PN) therapy. Part 1 of this series addressed issues associated with and safety recommendations pertaining to adult ILE use. Part 2 addresses ILE safety in neonatal and pediatric patients. Considerations for ILE use in the neonatal and pediatric populations differ from those of adults. For example, these patients often require higher doses compared with adult counterparts to support growth, development, and daily metabolic needs. ILE is also frequently administered as a separate infusion as opposed to in a total nutrient admixture owing to compatibility and stability issues and limitations to intravenous access in the neonatal and pediatric populations. ILE is the most frequent PN ingredient associated with PN errors occurring in the administration, prescribing, and transcribing processes. Concerns exist with use of in-line filters and repackaging of commercial products for infusion. ILE use in neonatal and pediatric patients has been associated with both minor and major adverse effects, which most often occur with doses exceeding manufacturer recommendations. Gaps in ILE best practices for neonatal and pediatric patients predispose to errors in the PN use system. This paper describes safe-use considerations for ILE products available in the United States in neonatal and pediatric patients, including indications, prescribing, order review, preparation, administration, and monitoring. This paper has been approved by the American Society for Parenteral and Enteral Nutrition (ASPEN) Board of Directors.

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.

Single High-dose Vitamin D3 Supplementation in Pediatric Patients With Inflammatory Bowel Disease and Hypovitaminosis D.

OBJECTIVES: The primary aim was to determine the effectiveness of a single high-dose of oral vitamin D3 (stoss therapy) in children with inflammatory bowel disease (IBD) and hypovitaminosis D. Our secondary aim was to examine the safety of stoss therapy. METHODS: We conducted a randomized, prospective study of 44 patients, ages 6 to 21 years, with IBD and 25-hydroxyvitamin D (25-OHD) concentrations <30 ng/mL. Patients were randomized to receive 50,000 IU of vitamin D3 once weekly for 6 weeks (standard of care, SOC group) or 300,000 IU once (stoss group). Serum 25-OHD levels were obtained at baseline, 4 and 12 weeks. Safety monitoring labs were performed at week 4. RESULTS: Thirty-nine of 44 enrolled patients (19 stoss, 20 SOC) completed the study. Baseline vitamin D levels were not significantly different between the groups. Stoss therapy resulted in a substantial rise in 25-OHD levels at week 4, equivalent to the weekly regimen (53.6 ±â€Š17.3 vs 54.6 ±â€Š17.5 ng/mL). At week 12, serum 25-OHD levels decreased in both groups, significantly lower in the stoss group, but remained close to 30 ng/mL (29.8 ±â€Š7.1 vs 40.4 ±â€Š11.9 ng/mL, P = 0.04). A significant interaction with treatment group over time was observed (P = 0.0003). At the week-4 time point, all patients who received stoss therapy had normal serum calcium and PTH levels. Eighty percentage of patients preferred stoss therapy to the weekly regimen. CONCLUSIONS: Stoss therapy was safe and effective in raising 25-OHD in children with IBD commensurate to that of the weekly regimen.

A Call to Action for Optimizing the Electronic Health Record in the Parenteral Nutrition Workflow: Executive Summary.

Parenteral nutrition (PN) is a complex therapeutic modality provided to neonates, children, and adults for various indications. Surveys have shown that current electronic health record (EHR) systems are in need of functionality enhancement for safe and optimal delivery of PN. This is a consensus statement from the American Society for Parenteral and Enteral Nutrition, the Academy of Nutrition and Dietetics, and the American Society of Health-System Pharmacists outlining some of the key challenges to prescribing, order review/verification, compounding, and administration of PN using EHRs today and is a call to action for clinicians and vendors to optimize their EHRs regarding the PN build and workflow.

A call to action for optimizing the electronic health record in the parenteral nutrition workflow.

Parenteral nutrition (PN) is a complex therapeutic modality provided to neonates, children, and adults for various indications. Surveys have shown that current electronic health record (EHR) systems are in need of functionality enhancement for safe and optimal delivery of PN. This is a consensus statement from the American Society for Parenteral and Enteral Nutrition, the Academy of Nutrition and Dietetics, and the American Society of Health-System Pharmacists outlining some of the key challenges to prescribing, order review/verification, compounding, and administration of PN using EHRs today and is a call to action for clinicians and vendors to optimize their EHRs regarding the PN build and workflow.

A Call to Action for Optimizing the Electronic Health Record in the Parenteral Nutrition Workflow.

Parenteral nutrition (PN) is a complex therapeutic modality provided to neonates, children, and adults for various indications. Surveys have shown that current electronic health record (EHR) systems are in need of functionality enhancement for safe and optimal delivery of PN. This is a consensus statement from the American Society for Parenteral and Enteral Nutrition, the Academy of Nutrition and Dietetics, and the American Society of Health-System Pharmacists outlining some of the key challenges to prescribing, order review/verification, compounding, and administration of PN using EHRs today and is a call to action for clinicians and vendors to optimize their EHRs regarding the PN build and workflow.

A Call to Action for Optimizing the Electronic Health Record in the Parenteral Nutrition Workflow.

Parenteral nutrition (PN) is a complex therapeutic modality provided to neonates, children, and adults for various indications. Surveys have shown that current electronic health record (EHR) systems are in need of functionality enhancement for safe and optimal delivery of PN. This is a consensus statement from the American Society for Parenteral and Enteral Nutrition, the Academy of Nutrition and Dietetics, and the American Society of Health-System Pharmacists outlining some of the key challenges to prescribing, order review/verification, compounding, and administration of PN using EHRs today and is a call to action for clinicians and vendors to optimize their EHRs regarding the PN build and workflow.

Follow-Up Survey on Functionality of Nutrition Documentation and Ordering Nutrition Therapy in Currently Available Electronic Health Record Systems.

BACKGROUND: This is a follow-up survey to reassess the safety and efficacy of nutrition content in the available electronic health record (EHR) systems. MATERIALS AND METHODS: Members of the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.), American Society for Nutrition, and the Academy for Nutrition and Dietetics were asked to participate in an online survey. The survey included questions from a 2012 EHR survey on the safety and efficacy in 5 nutrition content areas as well as questions from previous 2003 and 2011 A.S.P.E.N. parenteral nutrition (PN) surveys. RESULTS: Percent of respondents using an EHR and using the EHR for less than 1 year increased between 2012 and 2014 (86%-94%, P < .05; 11%-16%, P < .05, respectively). However, there was no improvement in the safety and efficacy of the 5 nutrition content areas, with a significant decrease in 2 of these areas, ordering oral nutrition supplements and ordering PN. The top-rated EHR vendors had a higher average favorable response rate in regards to safety and efficacy in the nutrition content areas but even the top-rated EHR vendor had only a 60% average in favorable responses. Reported use of electronic PN ordering and a direct interface between the EHR and the automated compounding device (ACD) significantly increased from 2003 to 2011 to 2014 (29% to 33% to 63% and 16% to 19% to 28%, respectively, P < .05). CONCLUSIONS: This is a call to action to nutrition support clinicians, societies, and organizations to proactively be involved in initiatives to educate clinicians and collaborate with EHR vendors to enhance the EHR systems to improve the safety and efficacy of providing nutrition therapy in hospitalized patients.

Efficacy and safety of using L-cysteine as a catheter-clearing agent for nonthrombotic occlusions of central venous catheters in children.

Critically ill pediatric patients, especially in the intensive care unit, receive multiple medications and have a higher risk of central venous catheter (CVC) occlusion. If an occlusion occurs immediately after the administration of multiple medications or incompatible medications, either an acidic solution such as 0.1 N hydrochloric acid (HCl) or a basic solution of 1 mEq/mL sodium bicarbonate or 0.1 N sodium hydroxide can be used. However, compounding and storing of 0.1 N HCl has become more complex due to USP <797> guidelines for sterile compounding, and an alternative is needed. We report a series of cases in which L-cysteine was used instead of HCl to clear CVCs occluded due to administration of multiple medications. L-cysteine is a commercially available, sterile solution with a pH of 1­2.5. CVC occlusion was resolved in 10 of the 16 episodes in 13 patients. Two of the 16 occlusions were phenytoin related and would not have responded. An L-cysteine dose of 50 mg was used during 10 of the 16 episodes, 100 mg during 5 episodes, and 25 mg during 1 episode. A correlation between catheter clearance and dose was not observed. Occlusion resolution due to L-cysteine was not correlated to the prior use of tissue plasminogen activator. Metabolic acidosis, adverse effects, or damage to the catheters due to L-cysteine were not observed. On the basis of this limited experience, we propose L-cysteine as an effective alternative to 0.1 N HCl for clearing CVC occlusions caused by drugs with an acidic pKa.

Defining pediatric malnutrition: a paradigm shift toward etiology-related definitions.

Lack of a uniform definition is responsible for underrecognition of the prevalence of malnutrition and its impact on outcomes in children. A pediatric malnutrition definitions workgroup reviewed existing pediatric age group English-language literature from 1955 to 2011, for relevant references related to 5 domains of the definition of malnutrition that were a priori identified: anthropometric parameters, growth, chronicity of malnutrition, etiology and pathogenesis, and developmental/ functional outcomes. Based on available evidence and an iterative process to arrive at multidisciplinary consensus in the group, these domains were included in the overall construct of a new definition. Pediatric malnutrition (undernutrition) is defined as an imbalance between nutrient requirements and intake that results in cumulative deficits of energy, protein, or micronutrients that may negatively affect growth, development, and other relevant outcomes. A summary of the literature is presented and a new classification scheme is proposed that incorporates chronicity, etiology, mechanisms of nutrient imbalance, severity of malnutrition, and its impact on outcomes. Based on its etiology, malnutrition is either illness related (secondary to 1 or more diseases/injury) or non-illness related, (caused by environmental/behavioral factors), or both. Future research must focus on the relationship between inflammation and illness-related malnutrition. We anticipate that the definition of malnutrition will continue to evolve with improved understanding of the processes that lead to and complicate the treatment of this condition. A uniform definition should permit future research to focus on the impact of pediatric malnutrition on functional outcomes and help solidify the scientific basis for evidence-based nutrition practices.