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Aluminium is the most common metallic element, but has no known biological role. It accumulates in the body when protective gastrointestinal mechanisms are bypassed, renal function is impaired, or exposure is high – all of which apply frequently to preterm infants. Recognised clinical manifestations of aluminium toxicity include dementia, anaemia and bone disease. Parenteral nutrition (PN) solutions are liable to contamination with aluminium, particularly from acidic solutions in glass vials, notably calcium gluconate. When fed parenterally, infants retain >75% of the aluminium, with high serum, urine and tissue levels. Later health effects of neonatal intravenous aluminium exposure were investigated in a randomised trial comparing standard PN solutions with solutions specially sourced for low aluminium content. Preterm infants exposed for >10 d to standard solutions had impaired neurologic development at 18 months. At 13–15 years, subjects randomised to standard PN had lower lumbar spine bone mass; and, in non-randomised analyses, those with neonatal aluminium intake above the median had lower hip bone mass. Given the sizeable number of infants undergoing intensive care and still exposed to aluminium via PN, these findings have contemporary relevance. Until recently, little progress had been made on reducing aluminium exposure, and meeting Food and Drug Administration recommendations (<5 μg/kg per d) has been impossible in patients <50 kg using available products. Recent advice from the UK Medicines and Healthcare regulatory Authority that calcium gluconate in small volume glass containers should not be used for repeated treatment in children <18 years, including preparation of PN, is an important step towards addressing this problem.

Early parenteral nutrition to supplement insufficient enteral feeding during intensive care (early PN) delays recovery as compared with withholding parenteral nutrition for 1 week (late PN). To assess whether deleterious effects of early PN relate to severity of illness or to the dose or type of macronutrients. Secondary analyses of a randomized controlled trial (EPaNIC; n = 4,640) performed in seven intensive care units from three departments in two Belgian hospitals. In part 1, all patients were included to assess the effect of the randomized allocation to early PN or late PN in subgroups of patients with increasing-on-admission severity of illness. In part 2, observationally, the association of the amount and type of macronutrients with recovery was documented in those patient cohorts still present in intensive care on Days 3, 5, 7, 10, and 14. The primary end point was time to live discharge from the intensive care unit. For part 1, a secondary end point, acquisition of new infections, was also analyzed. All statistical analyses were performed by univariable and adjusted multivariable methods. In none of the subgroups defined by type or severity of illness was a beneficial effect of early PN observed. The lowest dose of macronutrients was associated with the fastest recovery and any higher dose, administered parenterally or enterally, was associated with progressively more delayed recovery. The amount of proteins/amino acids rather than of glucose appeared to explain delayed recovery with early feeding. Early combined parenteral/enteral nutrition delayed recovery irrespective of severity of critical illness. No dose or type of macronutrient was found to be associated with improved outcome. Clinical trial registered with www.clinicaltrials.gov (NCT 00512122).

In this study comparing the delivery of early nutritional support through the parenteral route with delivery through the enteral route in critically ill adults, there was no significant difference in 30-day mortality between the groups. Nutritional support is standard for critically ill patients and requires a complex calculus of timing, route of delivery, and the amount and type of nutrients that are administered — all of which may affect patient outcomes. The interpretation of published meta-analyses of trials comparing nutritional support through the parenteral route versus the enteral route in critically ill patients 1 – 3 is complicated by small sample sizes, variable quality, selection bias, lack of standardized definitions, and interventions that combine multiple elements of nutritional support (e.g., timing and route). Currently, the enteral route is the mainstay, largely on the grounds of physiological rationale . . .

Background Nutritional support is crucial to the management of patients receiving invasive mechanical ventilation (IMV) and the most commonly prescribed treatment in intensive care units (ICUs). International guidelines consistently indicate that enteral nutrition (EN) should be preferred over parenteral nutrition (PN) whenever possible and started as early as possible. However, no adequately designed study has evaluated whether a specific nutritional modality is associated with decreased mortality. The primary goal of this trial is to assess the hypothesis that early first-line EN, as compared to early first-line PN, decreases day 28 all-cause mortality in patients receiving IMV and vasoactive drugs for shock. Methods/Design The NUTRIREA-2 study is a multicenter, open-label, parallel-group, randomized controlled trial comparing early PN versus early EN in critically ill patients requiring IMV for an expected duration of at least 48 hours, combined with vasoactive drugs, for shock. Patients will be allocated at random to first-line PN for at least 72 hours or to first-line EN. In both groups, nutritional support will be started within 24 hours after IMV initiation. Calorie targets will be 20 to 25 kcal/kg/day during the first week, then 25 to 30 kcal/kg/day thereafter. Patients receiving PN may be switched to EN after at least 72 hours in the event of shock resolution (no vasoactive drugs for 24 consecutive hours and arterial lactic acid level below 2 mmol/L). On day 7, all patients receiving PN and having no contraindications to EN will be switched to EN. In both groups, supplemental PN may be added to EN after day 7 in patients with persistent intolerance to EN and inadequate calorie intake. We plan to recruit 2,854 patients at 44 participating ICUs. Discussion The NUTRIREA-2 study is the first large randomized controlled trial designed to assess the hypothesis that early EN improves survival compared to early PN in ICU patients. Enrollment started on 22 March 2013 and is expected to end in November 2015. Trial registration ClinicalTrials.gov Identifier: NCT01802099 (registered 27 February 2013)

•Peripherally inserted central catheter (PICC) is crucial in treating preterm neonates.•The effectiveness of heparin for reducing PICC occlusion is controversial.•Scanning electron microscopy is used for first time for judging catheter obstruction.•Adding heparin may be unnecessary for the maintaining of PICC in preterm neonates. This study aimed to assess the need for adding heparin to parenteral nutrition (PN) on reducing catheter intraluminal obstruction based on scanning electron microscopy (SEM) of peripherally inserted central catheter (PICC) in preterm neonates. In this randomized controlled blinded non-inferiority trial, neonates with gestational age <32 weeks requiring PICC to receive PN were enrolled and randomly divided into two groups. In the heparin group, 0.5 IU/mL heparin was added to PN for continuous infusion through PICC; while in the no-heparin group, there was no heparin added. All catheter tips were collected for SEM of catheter intraluminal obstruction. The primary outcome was the ratio of intraluminal obstructed area at catheter tip calculated by SEM. A non-inferiority margin of 0.1 was chosen. The duration of catheter patency, incidence of catheter-related complications, and heparin-related side effects were analyzed. Between June 1, 2021, and May 31, 2022, 91 neonates (gestational age of 28.17 ± 1.77 weeks) were ultimately enrolled. In the intention-to-treat analysis, the average ratio of intraluminal obstructed area at catheter tip indicated by SEM in no-heparin group was 0.313, and 0.362 in the heparin group (95% confidence intervals of the differences was –0.028 to 0.147). The lower bound of the one-side 95% confidence intervals was greater than –0.1, indicating non-inferiority. No statistically significant differences existed in the duration of catheter patency, the incidence of catheter-related complications between two groups. PN without heparin was non-inferior to the addition of 0.5 IU/mL heparin to PN during infusion on reducing catheter intraluminal obstruction based on SEM of PICC in preterm neonates. These findings could reduce the unnecessary exposure to heparin in preterm neonates.

Background As compared to withholding parenteral nutrition (PN) until one week after intensive care unit (ICU) admission, Early PN prolonged ICU dependency in the EPaNIC randomized controlled trial (RCT). The Refeeding RCT showed improved outcome by temporary macronutrient restriction in ICU patients developing refeeding hypophosphatemia, defined as a phosphate decrease of > 0.16 mmol/L to levels < 0.65 mmol/L. We hypothesized that early phosphate changes may identify critically ill patients who are harmed by Early PN, and that dynamic phosphate changes are more discriminative than an absolute threshold for hypophosphatemia. Methods In this secondary analysis of the EPaNIC RCT, we studied whether absolute hypophosphatemia (AHP; < 0.65 mmol/L on the second ICU-day), relative hypophosphatemia (RHP; > 0.16 mmol/L decrease over the first 2 ICU-days), or a combination of both (CHP) interacted with the randomized nutritional strategy for its impact on outcome, adjusted for risk factors. In case of significant interaction, we studied whether the respective change could be predicted by baseline characteristics. Results Of 3520 patients with available phosphate measurements, AHP developed in 9.1%, RHP in 23.7%, and CHP in 5.3% of patients. RHP, but not AHP or CHP, interacted with the randomized intervention for its impact on outcome ( p  = 0.01). In RHP patients, Early PN independently associated with a lower likelihood of an earlier discharge alive from ICU (adjusted HR 0.75 [0.65–0.87]). In patients without RHP, Early PN did not significantly associate with this outcome (adjusted HR 0.93 [0.86–1.00]). Development of RHP was only poorly predicted by admission characteristics (adjusted pseudo R-squared = 1.7%). Conclusion Development of RHP may identify patients who are particularly harmed by early PN. Future studies should prospectively validate the potential of including RHP in a ready-to-feed indicator.

The objective of this study was to investigate the efficacy and safety of intradialytic parenteral nutrition (IDPN) using ENEFLUID ® (310 kcal, 550 mL) in mild-moderate malnutrition patients receiving maintenance hemodialysis. A total of 40 adult patients with a Nutritional Risk Index-Japanese Hemodialysis (NRI-JH) score of 5–10 were enrolled in this multicenter, randomized, open-label study. Patients in the intervention group received IDPN using ENEFLUID ® via the dialysis circuit 3 times a week for 12 weeks; those in the control group did not. The primary endpoint was change in serum transthyretin (TTR). The secondary endpoints were changes in nutritional laboratory tests, nutritional parameters, food intake, plasma amino acids, and blood glucose. For both groups, mean age (72.1±11.4 years) and BMI (20.3±3.0), and median NRI-JH score [7.0 (interquartile range, 6–8)], did not differ. One patient withdrew before intervention, leaving 20 intervention and 19 control patients. Mean (95% confidence interval) change in serum TTR (mg/dL) at 12 weeks did not differ between groups: Intervention, 1.0 (-1.1–3.2); Control, -0.3 (-2.4–1.9); Intragroup difference, 1.3 (-1.7–4.3); P = 0.41. The values reflecting protein intake at 12 weeks compared to those on the study initiation day increased in the intervention group [the changes of blood urea nitrogen, 9.4 (2.6–16.2) mg/dL; P = 0.007, and normalized protein catabolic rate, 0.10 (0.02–0.18) g/kg/day; P = 0.02]. Mean food protein intake (g/kg/day) at 12 weeks increased in the intervention group and decreased in the control group, and differed between groups: Intervention, 0.12 (-0.03–0.28); Control, -0.18 (-0.43–0.08); Inter-group difference, 0.30 (0.00–0.60); P = 0.050. No adverse events occurred. In patients with mild to moderate malnutrition receiving ENEFLUID ® for 12 weeks as IDPN, serum TTR was not improved, decreases in protein intake was mitigated, no adverse events occurred. Trial registration Name of the registry: Japan Registry of Clinical Trials Registration number: jRCTs031220296 .

Background It is proposed that the development of parenteral nutrition-associated cholestasis (PNAC) was significantly associated with preterm birth, low birth weight, infection, etc.; however, the etiology and pathogenesis of PNAC are not fully understood. Most of the studies examining PNAC-associated risk factors were single-center studies with relatively small sample sizes. Objective To analyze the risk factors associated with PNAC in preterm infants in China. Methods This is a retrospective multicenter observational study. Clinical data on the effect of multiple oil-fat emulsions (soybean oil-medium chain triglycerides-olive oil-fish oil, SMOF) in preterm infants were collected from a prospective multicenter randomized controlled study. A secondary analysis was performed in which preterm infants were divided into the PNAC group and the non-PNAC group based on the PNAC status. Results A total of 465 cases very preterm infants or very low birth weight infants were included in the study in which 81 cases were assigned to the PNAC group and 384 cases were assigned to the non-PNAC group. The PNAC group had a lower mean gestational age, lower mean birth weight, longer duration of invasive and non-invasive mechanical ventilation, a longer duration oxygen support, and longer hospital stay ( P  < 0.001 for all). The PNAC group had higher respiratory distress syndrome, hemodynamically significant patent ductus arteriosus, necrotizing enterocolitis (NEC) with stage II or higher, surgically treated NEC, late-onset sepsis, metabolic bone disease, and extrauterine growth retardation (EUGR) compared to the non-PNAC group ( P <  0.05 for all). In contrast with the non-PNAC group, the PNAC group received a higher maximum dose of amino acids and fat emulsion, more medium/long-chain fatty emulsion, less SMOF, had a longer duration of parenteral nutrition, lower rates of breastfeeding, higher incidence of feeding intolerance (FI), more accumulated days to achieve total enteral nutrition, less accumulated days of total calories up to standard 110 kcal/kg/day and slower velocity of weight growth ( P <  0.05 for all). Logistic regression analysis indicated that the maximum dose of amino acids ( OR , 5.352; 95% CI , 2.355 to 12.161), EUGR ( OR , 2.396; 95% CI , 1.255 to 4.572), FI ( OR , 2.581; 95% CI , 1.395 to 4.775), surgically treated NEC ( OR , 11.300; 95% CI , 2.127 ~ 60.035), and longer total hospital stay ( OR , 1.030; 95% CI , 1.014 to 1.046) were independent risk factors for the development of PNAC. SMOF ( OR , 0.358; 95% CI , 0.193 to 0.663) and breastfeeding ( OR , 0.297; 95% CI , 0.157 to 0.559) were protective factors for PNAC. Conclusions PNAC can be reduced by optimizing the management of enteral and parenteral nutrition and reducing gastrointestinal comorbidities in preterm infants.

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 ( R 2 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.

We examined gastric outlet obstruction (GOO) patients who received two weeks of strengthening pre-operative enteral nutrition therapy (pre-EN) through a nasal–jejenal feeding tube placed under a gastroscope to evaluate the feasibility and potential benefit of pre-EN compared to parenteral nutrition (PN). In this study, 68 patients confirmed to have GOO with upper-gastrointestinal contrast and who accepted the operation were randomized into an EN group and a PN group. The differences in nutritional status, immune function, post-operative complications, weight of patients, first bowel sound and first flatus time, pull tube time, length of hospital stay (LOH), and cost of hospitalization between pre-operation and post-operation were all recorded. Statistical analyses were performed using the chi square test and t-test; statistical significance was defined as p < 0.05. The success rate of the placement was 91.18% (three out of 31 cases). After pre-EN, the levels of weight, albumin (ALB), prealbumin (PA), and transferrin (TNF) in the EN group were significantly increased by pre-operation day compared to admission day, but were not significantly increased in the PN group; the weights in the EN group were significantly increased compared to the PN group by pre-operation day and day of discharge; total protein (TP), ALB, PA, and TNF of the EN group were significantly increased compared to the PN group on pre-operation and post-operative days one and three. The levels of CD3+, CD4+/CD8+, IgA, and IgM in the EN group were higher than those of the PN group at pre-operation and post-operation; the EN group had a significantly lower incidence of poor wound healing, peritoneal cavity infection, pneumonia, and a shorter first bowel sound time, first flatus time, and post-operation hospital stay than the PN group. Pre-EN through a nasal–jejunum feeding tube and placed under a gastroscope in GOO patients was safe, feasible, and beneficial to the nutrition status, immune function, and gastrointestinal function, and sped up recovery, while not increasing the cost of hospitalization.