Evidence-based recommendations of the Andalusian Group for Nutrition Reflection and Investigation (GARIN) for the management of adult patients with short bowel syndrome / Recomendaciones basadas en la evidencia del Grupo Andaluz para la Reflexión e Investigación en Nutrición (GARIN) para el manejo del paciente con síndrome de intestino corto

In order to develop evidence-based recommendations and expert consensus for the nutritional management of patients with short bowel syndrome (SBS), we conducted a systematic literature search using the PRISMA methodology plus a critical appraisal following the GRADE scale procedures. Pharmacological treatment with antisecretory drugs, antidiarrheal drugs, and somatostatin contributes to reducing intestinal losses. Nutritional support is based on parenteral nutrition; however, oral intake and/or enteral nutrition should be introduced as soon as possible. In the chronic phase, the diet should have as few restrictions as possible, and be adapted to the SBS type. Home parenteral nutrition (HPN) should be individualized. Single-lumen catheters are recommended and taurolidine should be used for locking the catheter. The HPN's lipid content must be greater than 1 g/kg per week but not exceed 1 g/kg per day, and omega-6 fatty acids (ω6 FAs) should be reduced. Trace element vials with low doses of manganese should be used. Patients with chronic SBS who require long-term HPN/fluid therapy despite optimized treatment should be considered for teduglutide treatment. All patients require a multidisciplinary approach and specialized follow-up. These recommendations and suggestions regarding nutritional management in SBS patients have direct clinical applicability. (AU)

Con el fin de desarrollar recomendaciones basadas en la evidencia y el consenso de expertos para el manejo nutricional de los pacientes con síndrome de intestino corto (SIC), realizamos una búsqueda bibliográfica sistemática utilizando la metodología PRISMA junto a una valoración crítica siguiendo los procedimientos de la escala GRADE. El tratamiento farmacológico con fármacos antisecretores, antidiarreicos y somatostatina contribuye a reducir las pérdidas intestinales. El apoyo nutricional se basa en la nutrición parenteral; sin embargo, la ingesta oral y/o la nutrición enteral deben introducirse lo antes posible. En la fase crónica, la dieta debe tener las menores restricciones posibles y adaptarse al tipo de SIC. La nutrición parenteral domiciliaria (NPD) debe individualizarse. Se recomiendan catéteres de un solo lumen y se debe utilizar taurolidina para bloquear el catéter. El contenido de lípidos de la HPN debe ser superior a 1 g/kg por semana, pero no debe exceder 1 g/kg por día, y debe reducirse el ácido graso omega-6 (AG ω6). Deben utilizarse viales de oligoelementos con dosis bajas de manganeso. Los pacientes con SIC crónico que requieren NPD/fluidoterapia a largo plazo a pesar del tratamiento optimizado deben considerarse para el tratamiento con teduglutida. Todos los pacientes requieren un abordaje multidisciplinar y un seguimiento especializado. Estas recomendaciones y sugerencias con respecto al manejo nutricional de los pacientes con SIC tienen aplicabilidad clínica directa. (AU)

Evidence-based recommendations of the Andalusian Group for Nutrition Reflection and Investigation (GARIN) for the management of adult patients with short bowel syndrome.

INTRODUCTION: In order to develop evidence-based recommendations and expert consensus for the nutritional management of patients with short bowel syndrome (SBS), we conducted a systematic literature search using the PRISMA methodology plus a critical appraisal following the GRADE scale procedures. Pharmacological treatment with antisecretory drugs, antidiarrheal drugs, and somatostatin contributes to reducing intestinal losses. Nutritional support is based on parenteral nutrition; however, oral intake and/or enteral nutrition should be introduced as soon as possible. In the chronic phase, the diet should have as few restrictions as possible, and be adapted to the SBS type. Home parenteral nutrition (HPN) should be individualized. Single-lumen catheters are recommended and taurolidine should be used for locking the catheter. The HPN's lipid content must be greater than 1 g/kg per week but not exceed 1 g/kg per day, and omega-6 fatty acids (ω6 FAs) should be reduced. Trace element vials with low doses of manganese should be used. Patients with chronic SBS who require long-term HPN/fluid therapy despite optimized treatment should be considered for teduglutide treatment. All patients require a multidisciplinary approach and specialized follow-up. These recommendations and suggestions regarding nutritional management in SBS patients have direct clinical applicability.

INTRODUCCIÓN: Con el fin de desarrollar recomendaciones basadas en la evidencia y el consenso de expertos para el manejo nutricional de los pacientes con síndrome de intestino corto (SIC), realizamos una búsqueda bibliográfica sistemática utilizando la metodología PRISMA junto a una valoración crítica siguiendo los procedimientos de la escala GRADE. El tratamiento farmacológico con fármacos antisecretores, antidiarreicos y somatostatina contribuye a reducir las pérdidas intestinales. El apoyo nutricional se basa en la nutrición parenteral; sin embargo, la ingesta oral y/o la nutrición enteral deben introducirse lo antes posible. En la fase crónica, la dieta debe tener las menores restricciones posibles y adaptarse al tipo de SIC. La nutrición parenteral domiciliaria (NPD) debe individualizarse. Se recomiendan catéteres de un solo lumen y se debe utilizar taurolidina para bloquear el catéter. El contenido de lípidos de la HPN debe ser superior a 1 g/kg por semana, pero no debe exceder 1 g/kg por día, y debe reducirse el ácido graso omega-6 (AG ω6). Deben utilizarse viales de oligoelementos con dosis bajas de manganeso. Los pacientes con SIC crónico que requieren NPD/fluidoterapia a largo plazo a pesar del tratamiento optimizado deben considerarse para el tratamiento con teduglutida. Todos los pacientes requieren un abordaje multidisciplinar y un seguimiento especializado. Estas recomendaciones y sugerencias con respecto al manejo nutricional de los pacientes con SIC tienen aplicabilidad clínica directa.

Advances in Medical Nutrition Therapy: Parenteral Nutrition.

Parenteral nutrition has evolved tremendously, with parenteral formulas now safer and more accessible than ever. "All-in-one" admixtures are now available, which simplify parenteral nutrition usage and decrease line infection rates alongside other methods of infectious control. Recently published data on the benefits of parenteral nutrition versus enteral nutrition together with the widespread use of indirect calorimetry solve many safety issues that have emerged over the years. All these advances, alongside a better understanding of glycemic control and lipid and protein formulation improvements, make parenteral nutrition a safe alternative to enteral nutrition.

MicroRNAs as potential markers of parenteral nutrition associated liver disease in adult patients.

Parenteral nutrition-associated liver disease (PNALD) is a severe complication in patients completely dependent on parenteral nutrition (PN). The gold diagnostic standard, liver biopsy, is associated with significant health risk and therefore its use is limited. MicroRNAs (miRNAs) are small non-coding regulatory RNA molecules with highly tissue-specific expression and the secreted miRNAs may serve as non-invasive diagnostic biomarkers. The aim of this study was to evaluate the expression of a panel of specific miRNAs associated with liver diseases of different origin in PN-dependent adult patients in order to design miRNA panel enabling to precise monitoring of PNALD progression. Twelve PN-dependent patients with short bowel syndrome (SBS) were monitored on three/four-month basis for up to 24 months. Forty-five age- and sex-matched subjects without any known liver pathology served as controls. Specific miRNAs expression was determined by RT-qPCR using TaqMan probes (Thermofisher). Liver function test parameters were determined in certified clinical laboratories. Six of the tested miRNAs exhibited significantly altered expression compared with healthy controls, three of them (MIR122, MIR1273g, and MIR500a) were upregulated while three were down-regulated (MIR505, MIR199a, MIR139). MIR122 positively correlated with serum AST and ALT activities while MIR1273g positively correlated with serum CRP concentration and GGT activity. MIR505, MIR199a, and MIR139 negatively correlated with serum GGT activity. Fluctuation of these parameters well paralleled serum miRNA concentrations in all patients throughout the whole observation period. We identified six miRNAs whose serum concentrations are significantly altered in PN-dependent patients with PNALD and correlate with markers of inflammation, cholestasis or hepatic injury. Their reliability as markers of PNALD progression needs to be further evaluated.

Safety and efficacy of volume-based feeding in critically ill, mechanically ventilated adults using the 'Protein & Energy Requirements Fed for Every Critically ill patient every Time' (PERFECT) protocol: a before-and-after study.

BACKGROUND: Underfeeding in critical illness is common and associated with poor outcomes. According to large prospective hospital studies, volume-based feeding (VBF) safely and effectively improves energy and protein delivery to critically ill patients compared to traditional rate-based feeding (RBF) and might improve patient outcomes. A before-and-after study was designed to evaluate the safety, efficacy and clinical outcomes associated with VBF compared to RBF in a single intensive care unit (ICU). METHODS: The sample included consecutively admitted critically ill adults, mechanically ventilated for at least 72 h and fed enterally for a minimum of 48 h. The first cohort (n = 46) was fed using RBF, the second (n = 46) using VBF, and observed for 7 days, or until extubation or death. Statistical comparison of percentage feed volume, energy and protein delivered, plus indices of feed intolerance, were the primary outcomes of interest. Secondary observations included ventilation period, mortality, and length of ICU stay (LOICUS). RESULTS: Groups were comparable in baseline clinical and demographic characteristics and nutrition practices. Volume delivered to the VBF group increased significantly by 11.2% (p ≤ 0.001), energy by 13.4% (p ≤ 0.001) and protein by 8.4% (p = 0.02), compared to the RBF group. In the VBF group, patients meeting > 90% of energy requirements increased significantly from 47.8 to 84.8% (p ≤ 0.001); those meeting > 90% of protein requirements changed from 56.5 to 73.9% (p = 0.134). VBF did not increase symptoms of feed intolerance. Adjusted binomial logistic regression found each additional 1% of prescribed feed delivered decreased the odds of vomiting by 0.942 (5.8%), 95% CI [0.900-0.985], p = 0.010. No differences in mortality or LOICUS were identified. Kaplan-Meier found a significantly increased extubation rate in patients receiving > 90% of protein requirements compared to those meeting < 80%, (p = 0.006). Adjusted Cox regression found the daily probability of being extubated tripled in patients receiving > 90% of their protein needs compared to the group receiving < 80%, hazard ratio 3.473, p = 0.021, 95% CI [1.205-10.014]. CONCLUSION: VBF safely and effectively increased the delivery of energy and protein to critically ill patients. Increased protein delivery may improve extubation rate which has positive patient-centred and financial implications, warranting larger confirmatory trials. This investigation adds weight to the ICU literature supporting VBF, and the growing evidence which advocates for enhanced protein delivery to improve patient outcomes.

Registro del Grupo NADYA-SENPE de Nutrición Enteral Domiciliaria en España; años 2016 y 2017 / Spanish home enteral nutrition registry of the year 2016 and 2017 from the NADYA-SENPE Group

Objetivo: exponer los resultados del registro de nutrición enteral domiciliaria (NED) de los años 2016 y 2017 del Grupo NADYA-SENPE. Material y métodos: se recopilaron los pacientes introducidos en el registro del 1 de enero al 31 de diciembre de 2016 y la mismas fechas de 2017 para proceder al análisis descriptivo y analítico de los datos. Resultados: en el año 2016 se obtuvieron 4.578 pacientes activos (prevalencia = 98,33 pacientes/millón de habitantes) y en 2017 fueron 4.777 (prevalencia = 102,57). Por sexos, hubo un 50,8% de varones en 2016 y un 50,5% en 2017. En el periodo 2016-17, la edad mediana fue de 71,5 años (IIQ 57-83); asimismo, finalizaron 1.558 episodios de NED y la causa principal fue el fallecimiento (793 pacientes, 50,89%). Los varones adultos fueron más jóvenes que las mujeres (65,3 vs. 73,3 años, p-valor < 0,001) y el diagnóstico más frecuente fue la enfermedad neurológica que cursa con afagia o disfagia severa (59%). La sonda nasogástrica (SNG) fue la vía de acceso más utilizada (48,3%) y se observa, además, que esta es la vía que se utiliza en los pacientes más ancianos (p < 0,001). Se registraron 126 pacientes pediátricos (57,1% niñas). La edad mediana de inicio de la NED fue de cuatro meses. Otras patologías fue el grupo diagnóstico más registrado (41,3%), seguido por la enfermedad neurológica que cursa con afagia o disfagia severa. Se alimentaban a través de gastrostomía en el 57,6% de los casos. Se observó que los niños más pequeños eran los que se alimentaban preferentemente por SNG (p-valor 0,001). Conclusiones: el número de pacientes del registro, así como el número de centros participantes, se va incrementando progresivamente. Las principales características de los pacientes no han variado. A pesar del aumento de posibilidades diagnósticas en la población pediátrica, llama la atención la clasificación dentro del grupo de Otras patologías

Objective: to present the results of the Spanish home enteral nutrition (HEN) registry of the NADYA-SENPE group for the year 2016 and 2017. Material and methods: from January 1st 2016 to December 31st 2017, the HEN registry was recorded and afterwards a further descriptive and analytical analysis was done. Results: in 2016, 4,578 active patients were recorded and prevalence was 98.33 patients per one million inhabitants; in 2017, 4,777 patients were recorded, with a prevalence of 102.57 per one million inhabitants; 50.8% were males in 2016 and 50.5% in 2017. During the period 2016-17, median age was 71.5 years (IIQ 57-83), 1,558 HEN episodes were finished and the main cause was death (793 patients, 50.89%). Adult males were younger than females (65.3 vs. 73.3 years, p-value < 0.001). The most frequent diagnosis was the neurological disorder that presents with aphagia or severe dysphagia (59%). Nasogastric tube was the most frequent administration route (48.3%) and it is the most widely used in elderly patients (p < 0.001). One hundred and twenty-six pediatric patients were registered (57.1% females). Median age at the beginning of HEN in children was four months. "Other disorders" was the most recorded diagnostic group (41.3%), followed by the group of neurological disorder that presents with aphagia or severe dysphagia. Regarding children, 57.6% were fed through gastrostomy and the younger ones were fed through nasogastric tube (p-value 0.001). Conclusions: the number of patients in the registry, as well as the number of participating centers, is progressively increasing. The main characteristics of the patients have not changed. Despite the increase in diagnostic possibilities in the pediatric population, the classification within the group of "Other pathologies" is quite significant

Parenteral nutrition in the ICU: Lessons learned over the past few years.

Since the early 1990s enteral nutrition (EN) has been considered the optimal route of feeding rather than parenteral nutrition (PN), which was considered harmful in critically ill patients with intense inflammation. The aim of this review was to summarize recent developments and progress in PN, which have changed the view on this feeding technique. PubMed and personal databases were searched for studies and reviews reporting historical development of PN, and for clinical trials conducted after 2010 investigating PN in critical illness, comparing it to EN or not. Trials from the past decade have explored modalities and timing of artificial feeding. Trials based on equation-estimated energy targets and applying an early full feeding strategy have generally had negative results in terms of complications (infections, prolonged ventilation, and intestinal complications with EN). The few trials that based their targets on measured energy targets have achieved reduction of complications regardless of the route. Opposing enteral and parenteral feeding is no longer rational in the critical care setting. A pragmatic and reasonable approach offers better options for the individual patient. Although PN is simpler to deliver than EN, its metabolic consequences are more complicated to handle. A combination of both techniques may be a more reasonable approach in the sickest patients.

Nutritional Support Using Enteral and Parenteral Methods.

The purpose of this Clinical Practice Guideline is to provide an approach for optimal nutritional support in the postinjury period for those injured in combat. Indications and contraindications for enteral and parenteral nutrition are addressed. Timing of nutritional support, nutritional goals, energy requirements, and ideal formula selection for various types of traumatic injuries are addressed. Challenges encountered providing nutrional support for the traumatically injured in the deployed environment are also discussed.

Excipients in parenteral formulations: selection considerations and effective utilization with small molecules and biologics.

Excipients form a major component of pharmaceutical formulations and are classified as any ingredient other than the active ingredient which is included within the product formulation to improve drug product performance. Functional uses of excipients include improving solubility and stability, safety and efficacy, as bulking agents in lyophilized formulations, tonicity agents, and aiding in controlled or prolonged drug delivery. Parenteral formulations are sterile, pyrogen-free; free of particulate matter and by-pass the body's natural defense mechanisms. Excipients may demonstrate a synergistic effect when combined with an active ingredient but may also lead to unwanted reactions with the drugs and packaging components. Ideal excipients are required to be considered safe, inert and multifunctional. Contrary to the past, safety of excipients needs to be well established in order for their use in the pharmaceutical formulations. Therefore, careful consideration should be given while selecting an excipient. This review article provides an overview of the excipients used exclusively in small molecule and biological parenteral products including solutions, suspensions, and lyophilized formulations, information on the possible drug-excipient and drug-packaging interactions and the regulatory requirements for the use of pharmaceutical excipients. The readers will be able to have a comprehensive understanding of the excipients used in parenteral formulations.

Hypothyroidism and Iodine Deficiency in Children on Chronic Parenteral Nutrition.

BACKGROUND AND OBJECTIVES: Iodine is an essential trace element for maintenance of normal thyroid function. Normal thyroid function is a prerequisite for neurocognitive development and growth in children. In the United States, iodine is not routinely added as a trace element in parenteral nutrition (PN). Our objective was to determine the prevalence of iodine deficiency and hypothyroidism in children on chronic PN. METHODS: This was a cross-sectional study of children <17 years of age and using PN for >6 months at a tertiary children's hospital. Primary outcomes were spot urine iodine concentration (UIC), serum thyrotropin, and free thyroxine levels. RESULTS: Twenty-seven patients were identified (74% male). The median age at screening was 48 months (range: 7-213 months). The median duration on PN was 27 months (range: 11-77 months). Seventeen out of 20 patients (85%) were iodine deficient (spot UIC <100 µg/L), whereas 11 out of 20 patients (55%) were severely iodine deficient (spot UIC <20 µg/L). The prevalence of acquired hypothyroidism (elevated thyrotropin, low free thyroxine, and UIC <100 µg/L) was 33% (n = 8). None of the children with hypothyroidism screened for autoimmune thyroiditis had positive test results. There was no statistically significant association between duration of PN use and development of iodine deficiency (P = .08) or hypothyroidism (P = .96). CONCLUSIONS: Children on chronic PN are at risk for developing iodine deficiency and resultant hypothyroidism; hence, these children should be screened for these outcomes. Further studies are needed to define the temporal onset of iodine deficiency and timing to thyroid dysfunction related to PN.

A randomized trial of supplemental parenteral nutrition in underweight and overweight critically ill patients: the TOP-UP pilot trial.

BACKGROUND: Nutrition guidelines recommendations differ on the use of parenteral nutrition (PN), and existing clinical trial data are inconclusive. Our recent observational data show that amounts of energy/protein received early in the intensive care unit (ICU) affect patient mortality, particularly for inadequate nutrition intake in patients with body mass indices (BMIs) of <25 or >35. Thus, we hypothesized increased nutrition delivery via supplemental PN (SPN) + enteral nutrition (EN) to underweight and obese ICU patients would improve 60-day survival and quality of life (QoL) versus usual care (EN alone). METHODS: In this multicenter, randomized, controlled pilot trial completed in 11 centers across four countries, adult ICU patients with acute respiratory failure expected to require mechanical ventilation for >72 hours and with a BMI of <25 or ≥35 were randomized to receive EN alone or SPN + EN to reach 100% of their prescribed nutrition goal for 7 days after randomization. The primary aim of this pilot trial was to achieve a 30% improvement in nutrition delivery. RESULTS: In total, 125 patients were enrolled. Over the first 7 post-randomization ICU days, patients in the SPN + EN arm had a 26% increase in delivered calories and protein, whereas patients in the EN-alone arm had a 22% increase (both p < 0.001). Surgical ICU patients received poorer EN nutrition delivery and had a significantly greater increase in calorie and protein delivery when receiving SPN versus medical ICU patients. SPN proved feasible to deliver with our prescribed protocol. In this pilot trial, no significant outcome differences were observed between groups, including no difference in infection risk. Potential, although statistically insignificant, trends of reduced hospital mortality and improved discharge functional outcomes and QoL outcomes in the SPN + EN group versus the EN-alone group were observed. CONCLUSIONS: Provision of SPN + EN significantly increased calorie/protein delivery over the first week of ICU residence versus EN alone. This was achieved with no increased infection risk. Given feasibility and consistent encouraging trends in hospital mortality, QoL, and functional endpoints, a full-scale trial of SPN powered to assess these clinical outcome endpoints in high-nutritional-risk ICU patients is indicated-potentially focusing on the more poorly EN-fed surgical ICU setting. TRIAL REGISTRATION: NCT01206166.

Total Parenteral and Enteral Nutrition in the ICU: Evolving Concepts.

Appropriate nutrition in the hospital setting, particularly in critically ill patients, has long been tied to improving clinical outcomes. During critical illness, inflammatory mediators and cytokines lead to the creation of a catabolic state to facilitate the use of endogenous energy sources to meet increased energy demands. This process results in increasing the likelihood of overfeeding. The literature has revealed exponential advances in understanding the molecular basis of nutritional support and evolution of clinical protocols aimed at treating artificial nutritional support as a therapeutic intervention, preventing loss of lean body mass and metabolic deterioration to improve clinical outcomes in the critically ill.

Treatment of Enterocutaneous Fistulas, Then and Now.

BACKGROUND: An enterocutaneous fistula (ECF) is an aberrant connection between the gastrointestinal tract and the skin or atmosphere (enteroatmospheric fistula [EAF]). Multimodal treatment includes surgical procedures, nutrition support, and wound care. We evaluated our practice and compared our outcomes with previous results published from our institution. MATERIALS AND METHODS: We performed a retrospective analysis of hospitalized ECF/EAF patients admitted between January 2011 and November 2015. Patients with internal fistulas; active inflammatory bowel disease; malignancy; radiation treatment; end-stage renal, hepatic, or cardiac disease; and active alcoholism were excluded. Data collected included demographics, fistula characteristics, nutrition therapy, treatment, operative success, and hospital mortality. Parametric and nonparametric tests for independent and paired groups were performed. RESULTS: Thirty-one patients were included in the analysis. The median (interquartile range) age was 60 (53-76) years, and 81% were female. Parenteral nutrition was initially prescribed in 80% of patients, but 61% received enteral nutrition (EN) at some point during their hospitalization. Two patients were fed by fistuloclysis. Eighty percent of the patients underwent surgical repair a median of 12 months after diagnosis with 92% operative success. Surgical repair had a modest correlation with home discharge (ρ = 0.517, P = .003). A large proportion of patients (77%) were discharged home. The in-hospital mortality at our institution decreased from 44% in 1960 to 21% in 1970 to 3% in the current study. CONCLUSIONS: Modern treatment of ECF/EAF, including EN and advanced local wound care, is associated with improvements in clinical outcomes such as hospital mortality.

Is the glutamine story over?

Glutamine has been launched as a conditionally indispensible amino acid for the critically ill. Supplementation has been recommended in guidelines from international societies. Although data have been presented pointing out that glutamine supplementation may not be for everybody, recommendations for treatments and design of study protocols have included all critically ill patients. Results from more recent studies and meta-analyses indicate that indiscriminate use of glutamine supplementation in critically ill patients may actually cause harm rather than beneficial effects. This viewpoint sorts out arguments of controversy in the glutamine story.

Teduglutida: revisión de su uso en el síndrome de intestino corto / Teduglutide: a review of its use in short bowel syndrome

Introducción: la nutrición parenteral (NP) a largo plazo puede asociarse a complicaciones graves, con un deterioro importante de la calidad de vida de los pacientes con síndrome de intestino corto (SIC). La teduglutida, un análogo del péptido-2 similar al glucagón, pertenece a una nueva familia terapéutica y representa el primer abordaje no sintomático del SIC. Objetivos: revisar los datos preclínicos y clínicos en cuanto a eficacia y seguridad de la teduglutida. Resultados: la aprobación de la teduglutida se basó en los resultados de un estudio en fase III de 24 semanas, doble ciego, controlado con placebo (STEPS). Pacientes con fallo intestinal por SIC dependientes de NP ≥ 3 veces/semana durante ≥ 12 meses recibieron 0,05 mg/kg de teduglutida (n = 43) o placebo (n = 43) 1 vez/día. En la semana 24 hubo significativamente más respondedores en el grupo de la teduglutida que en el de placebo (63 s. 30%; p = 0,002). La reducción absoluta media del volumen de NP frente al valor basal en la semana 24 fue significativamente mayor con la teduglutida (4,4 vs. 2,3 l/semana; p < 0,001). La necesidad de NP se redujo ≥ 1 día en la semana 24 en el 54% de pacientes tratados con teduglutida vs. 23% con placebo. Del total de pacientes que recibieron teduglutida en los ensayos en fase III (n = 134), el 12% consiguió una autonomía completa de la NP. Por lo general, la administración subcutánea de teduglutida se toleró bien. Conclusiones: se ha demostrado que teduglutida recupera la absorción intestinal y reduce significativamente la dependencia de la NP, consiguiendo incluso la independencia en algunos pacientes (AU)

Introduction: Long-term Parenteral Support (PS) can be associated with serious complications, with a significant deterioration in the quality of life of patients with short bowel syndrome (SBS). Teduglutide is a recombinant analogue of glucagon-like peptide-2; it belongs to a novel therapeutic family and represents the first non-symptomatic approach against SBS. Objectives: To review the non-clinical and clinical data on efficacy and safety of teduglutide. Results: Teduglutide approval was based on results from a pivotal Phase III, 24-week, double-blind, placebo-controlled study (STEPS). SBS patients dependent on PS ≥ 3 times/week for ≥ 12 months received 0.05 mg/kg teduglutide (n = 43) or placebo (n = 43) 1 time/day. At week 24 there were signifi cantly more responders in the teduglutide group vs. placebo (63 vs. 30%; p = 0.002). The overall mean reduction vs. PS baseline volume at week 24 was significantly higher with teduglutide vs. placebo (4.4 vs. 2.3 l/ week, p < 0.001). At week 24 the need for PS was reduced in at least 1 day in 54% of patients treated with teduglutide vs. 23% with placebo. Of the total of patients who received teduglutide in phase III trials (n = 134), 12% achieved complete autonomy from PS. Subcutaneous teduglutide was generally well tolerated. Conclusions: Teduglutide has been shown to enhance intestinal absorptive capacity and signifi cantly reduce PS dependency, even achieving independency in some patients (AU)

Impact of a new aggressive nutrition policy incorporating early introduction of parenteral nutrition and mother's own milk on growth of preterm infants.

BACKGROUND: Most of the evidence on early feeding of preterm infants was derived from high income settings, it is equally important to evaluate whether it can be successfully implemented into less resourced settings. This study aimed to compare growth and feeding of preterm infants before and after the introduction of a new aggressive feeding policy in Penang Hospital, a tertiary referral hospital in a middle income country. METHODS: The new aggressive feeding policy was developed mainly from Cochrane review evidence, using early parenteral and enteral nutrition with standardized breastfeeding counselling aimed at empowering mothers to provide early expressed milk. A total of 80 preterm babies (34 weeks and below) discharged from NICU were included (40 pre- and 40 post-intervention). Pre and post-intervention data were compared. The primary outcome was growth at day 7, 14, 21 and at discharge and secondary outcomes were time to full oral feeding, breastfeeding rates, and adverse events. RESULTS: Complete data were available for all babies to discharge. One baby was discharged prior to day 14 and 10 babies before day 21, so growth data for these babies were unavailable. Baseline data were similar in the two groups. There was no significant weight difference at 7, 14, 21 days and at discharge. More post-intervention babies were breastfed at discharge than pre-intervention babies (21 vs. 8, P=0.005). Nosocomial infection (11 vs. 4, P=0.045), and blood transfusion were significantly lower in the postintervention babies than in the pre-intervention babies (31 vs. 13, P=0.01). The post-intervention babies were more likely to achieve shorter median days (interquartile range) to full oral feeding [11 (6) days vs. 13 (11) days, P=0.058] and with lower number affecting necrotising enterocolitis (0 vs. 5, P=0.055). CONCLUSION: Early aggressive parenteral nutrition and early provision of mother's milk did not result in improved growth as evidenced by weight gain at discharge. However we found more breastfeeding babies, lower nosocomial infection and transfusion rates. Our findings suggest that implementing a more aggressive feeding policy supported by high level scientific evidence is able to improve important outcomes.

Dysphagia in the high-risk infant: potential factors and mechanisms.

Neonatal dysphagia, or abnormalities of swallowing, represent a major global problem, and consequences of dysfunctional feeding patterns carry over into infancy and toddler age groups. Growth, development, and independent feeding skills are all delayed among high-risk infants. Such a group comprises premature birth, low-birth-weight, congenital anomalies, perinatal asphyxia, postsurgical, and sepsis categories. The conflict between pathophysiologic and pragmatic feeding strategies remains a major conundrum and is largely due to a lack of validated diagnostic approaches amid heterogeneity of the patient phenotype. Thus, well-tested feeding management strategies that can be generalizable are lacking. Furthermore, the aerodigestive symptoms and signs, potential risk factors, and contributory etiologies remain nonspecific. This article presents mechanistic evidence related to the pathophysiologic basis of neonatal dysphagia as well as potential opportunities to improve feeding abilities and long-term development.

Executive summary: evaluation of the evidence to support practice guidelines for nutritional care of preterm infants-the Pre-B Project.

Preterm birth (infants born at <37 wk of gestational age) is a significant clinical and public health challenge in the United States and globally. No universally accepted practice guidelines exist for the nutritional care of preterm infants. To address the current state of knowledge and to support systematic reviews that will be used to develop evidence-informed guidance, a consortium consisting of the American Academy of Pediatrics, the ASN, the American Society for Parenteral and Enteral Nutrition, the Academy of Nutrition and Dietetics, the Food and Drug Administration, the CDC, the USDA/Agricultural Research Service (USDA/ARS), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development/NIH initiated the Pre-B Project. The project included the constitution of 4 thematic working groups charged with the following tasks: 1) develop a series of topics/questions for which there is sufficient evidence to support a systematic review process to be conducted by the Academy of Nutrition and Dietetics' Evidence Analysis Library (EAL), leading to the development of new guidelines for nutritional care of preterm infants, and 2) develop a targeted research agenda to address priority gaps in our understanding of the role of nutrition in the health and development of preterm/neonatal intensive care unit infants. This review consists of a project overview including a summary of a workshop hosted by the USDA/ARS Children's Nutrition Research Center and summary reports of the 4 working groups established to address the following themes: 1) nutrient specifications, 2) clinical/practical issues in enteral feeding, 3) gastrointestinal and surgical issues, and 4) current standards for assessing infant feeding outcomes. These reports will serve as the basis for the ultimate guideline development process to be conducted by the Academy of Nutrition and Dietetics' EAL.