Neonatal Parenteral Nutrition Research Articles

Stability assessment of neonatal parenteral nutrition solutions with various amino acid concentrations

Objective To explore the influence of various concentrations of amino acid on the stability of neonatal parenteral nutrition solutions. Methods Five formulations were designed with 5 different amino acid concentrations containing the same components. The final amino acid concentrations of admixtures were 0%, 1%, 2%, 3%, and 3.5%, respectively. The appearance, pH, and osmolality were observed or measured after preparation (0 hour) and at 12, 24, 48 and 72 hours after preparation. The average size and the size distribution of the lipid globules were also evaluated by laser nanometer particle size analyzer. Results There was no observable alteration in color, phase separation, precipitate, and flocculation in any admixture at any of the observation time points. The mean pH values for all groups were between (5.49±0.01) to (6.19±0.01) within 72 hours. The mean osmolalities for all groups were between (774±3) to (1 106±13)mOsm/kg. The mean diameters of lipid globules for all groups were between (280.6±0.7)mm to (332.2±2.0)nm. The mean polydispersity for all groups were between (0.200±0.011) to (0.245±0.012). The enrichment of amino acid concentration was linked to lower pH (P=0.000), higher osmolality (P=0.000) and larger average lipid globules size (P=0.000). However, there was no distinct linear dependence between amino acid concentration and polydispersity value (P=0.628). Conclusion After 72 hours of storage at room temperature, the appearance, pH, osmolality, and the average lipid globules diameter of the parenteral nutrition solutions are within the safe range when the amino acid is not contained or the concentrations are no more than 3.5%. Key words: Amino acid; Fat emulsions, intravenous; Stability; Neonatal parenteral nutrition

Emerging Clinical Benefits of New-Generation Fat Emulsions in Preterm Neonates.

Soybean oil-based intravenous fat emulsions (IVFEs) have been the predominant parenteral nutrition IVFE used in the United States for neonates over the past 45 years. Even though this emulsion has proven useful in supplying infants with energy for growth and essential fatty acids, there have been concerns over its composition in the development of several morbidities, ranging from sepsis to liver disease, bronchopulmonary dysplasia, and impaired neurodevelopment and growth. The exact mechanisms that drive these morbidities in preterm infants are multifactorial, but potential contributors include high ω-6 (n-6) fatty acid composition, low docosahexaenoic acid and antioxidant supplementation, and the presence of potentially harmful nonnutritive components (eg, phytosterols). To address these issues, new-generation IVFEs with various types and amounts of fat have been developed containing greater amounts of the medium-chain fatty acids, long-chain polyunsaturated fatty acid, docosahexaenoic acid, lower concentrations of ω-6 polyunsaturated fatty acids, supplemental vitamin E, and low or negligible amounts of phytosterols. This review examines the clinical outcomes associated with different morbidities of parenteral nutrition in neonates who have received either soybean oil-based or new-generation IVFEs and addresses whether the proposed benefits of new-generation IVFEs have improved outcomes in the neonatal population.

Position Statement on Heparin Safety Concerns.

Position Statement on Heparin Safety Concerns.

Clinical observation of strictly control the infusion on the intervention of the premature infants' hard swelling and edema

Objective To explore the correlation between the infusion volume and infusion method with neonatal hard swelling, edema, looking for the best way to premature infusion. Methods A total of 62 cases of prematrue infants with gestational age ranged from 34 weeks to 36+ 5 weeks, and with weight equal or greater than 2kg were selected as the research objects.Compared different infusion method's efficacy through infusion speed control newborn room nurses on neonatal infusion volume. All the infants were randomly divided into A, B and C groups according to random number table method.Group A: the total volume was controlled, and infusion with conventional speed (5~6 drops a minute). Group B: the speed was controlled by trace injection pump infusion.Group C: the speed was controlled by 24 hours of continuous infusion pump, and then contrast in children with intravenous indwelling needle, the curative effect was observed.Three sets of liquid quantity control methods were for 1~3 days after the total amount (including milk, water and transfusion volume) for 50 ml/kg, 60 ml/kg, 80 ml/kg, 4~7 days 100 ml/kg, according to the daily intake of milk and water quantity adjusting infusion in children with quantity, infusion volume also includes parenteral nutrient solution: amino acids, fat milk, all consumption demand of reference to neonatal parenteral nutrition therapy concentration. Results Group C (in trace injection pump group 24 hours of continuous pumping) got best treatment effect, the degree of edema reduced, the swollen and complications of infusion reduced, the total cost reduced, the average hospitalization time of the child reduced(P<0.05). This method was better than that of Group A (the total control quantity, and speed of conventional infusion (5~6 drops/min) group) and Group B (control trace injection pump infusion speed, liquid input end of the day after the completion of treatment, do not need to 24 hours of continuous pumping group). It is worthy of clinical popularization and application. Conclusions Trace injection pump (in group C group 24 hours of continuous pumping) has best curative effect and the lightest edema and hard swollen complications. Key words: Strictly control the infusion; Intervention in the premature infant complications; Clinical observation

Aluminum Content of Neonatal Parenteral Nutrition Solutions: Options for Reducing Aluminum Exposure.

Calcium chloride (CaCl2 ) has been the only calcium additive available in the United States that has a low aluminum (Al) content. Calcium gluconate in glass vials (CaGluc-Gl) has a high Al content while calcium gluconate in plastic vials (CaGluc-Pl) has a low Al content. The purpose of this study was to measure Al concentrations in neonatal parenteral nutrition (PN) solutions prepared using various calcium additives. Samples of solutions compounded with CaCl2 or CaGluc-Gl and sodium phosphate (NaPhos) as well as CaGluc-Pl and sodium glycerophosphate (NaGP) with and without cysteine were analyzed for Al content. Samples of the cysteine and calcium gluconate additives were also sent for analysis. Solutions containing CaCl2 and CaGlu-Pl had mean Al concentrations of 1.2-2.3 mcg/dL, while those with CaGlu-Gl had mean concentrations of 14.6-15.1 mcg/dL. Solutions made with NaGP were low in Al content. The measured Al content of 2 lots of the cysteine additive were 168 ± 23 mcg/L and 126 ± 5 mcg/L. The Al concentration equalled 2730 ± 20 mcg/L for the CaGlu-Gl additive and 310 ± 80 mcg/L for the CaGlu-Pl additive. The study indicates that solutions containing CaCl2 or CaGluc-Pl and NaPhos or NaGP are low in Al content. Using these options for calcium and phosphate additives can limit aluminum intake from neonatal PN to levels within the Food and Drug Administration guideline of ≤5 mcg/kg/d.

Peripherally Inserted Central Catheters vs Peripheral Cannulas for Delivering Parenteral Nutrition in Neonates.

Is parenteral nutrition via peripherally inserted central catheters (PICCs) associated with better delivery of nutrition and growth and fewer adverse events compared with short peripheral cannulas in neonates? Compared with short peripheral cannulas, parenteral nutrition via PICCs is associated with better nutrient delivery and lower rates of subsequent catheters or cannulas placed and is not associated with increased rates of invasive infection.

Fish oil- and soy oil-based lipid emulsions in neonatal parenteral nutrition: a systematic review and meta-analysis.

The precise role of fish oil-based lipid emulsions (FBL=any lipid emulsion containing any amount of fish oil) and soy oil-based lipid emulsions (SBL=any lipid emulsion not containing fish oil or containing at least 50% soy oil) in neonatal parenteral nutrition (PN) needs to be explored. The PubMed, MedLine and Google Scholar databases were searched for randomised control trials in which PN with FBL and SBL was the only difference between intervention and control groups. Methodological quality was assessed based on the Cochrane handbook for systemic reviews and Jadad's score. Revman 5.2 software was used for meta-analysis. Of 420 trials, 25 met the inclusion criteria. The aggregate results showed that both FBLs and SBLs are beneficial. FBLs were associated with significantly lower incidences of cholestasis (relative risk (RR)=0.50; 95% confidence interval (CI)=0.27-0.92, P=0.03) compared with SBLs. FBLs also had a tendency to improve the rates of weight gain, increase in head circumference and the time to regain birth weight (mean difference (MD)=0.24; 95% CI=-0.63-0.15). SBLs were associated with reduced duration of respiratory support (MD=2.22, 95% CI=0.35-4.09, P=0.02) and mortality rate in the first 28 days (RR=1.24, 95% CI=-0.72-2.13). Both FBLs and SBLs are beneficial for neonatal PN. FBLs reduce cholestasis, and SBLs reduce the duration of respiratory support.

Effect of a Comprehensive Total Parenteral Nutrition Training Program on Knowledge and Practice of Nurses in NICU.

Parenteral nutrition is a lifesaving therapy for many infants who are unable to tolerate enteral feedings. It fulfils preterm neonates' needs for growth and development when their sizes or conditions preclude enteral feeding. Virtuous nursing care and close biochemical monitoring are absolutely essential for successful parenteral nutrition therapy. Since poor knowledge in parenteral nutrition can causes severe impairment to neonatal infants, the conduction of this study is essential. The present study aims to: (1) examine the knowledge and practice of nurses in total parenteral nutrition (TPN); (2) employ training programs for improving knowledge and practice in management of TPN in new-borns. A quasi-experimental study was carried out in Sarem Maternity Hospital in Tehran, Iran. The study population included nurses working in Neonatal Intensive Care Unit (NICU) who were included in the study using headcount census method (n=30). A two-part questionnaire including demographic information; 20 multiple choice questions on the nurses' knowledge of TPN therapy and 19-item 3-point Likert-type checklist on administration of TPN completed by observing the nurses' practice. To examine the reliability of the practice part, Cronbach's alpha method was used (α=0.78). Study interventions were mentoring education by the researcher and researcher-developed training manual and educational video and guidelines about neonatal parenteral nutrition. Before and after intervention data were collected and compared using paired t-test. The mean scores of nurses' knowledge before and afterward parenteral nutrition (PN) training program were 11.93±1.91 and 17.56±1.59, respectively. The mean scores of the nurses' practice earlier and after training program were 38.84±2.96 and 40.15±3.02, respectively. Comparing the mean scores of the nurses' familiarity, before and after taking the training course, demonstrated a significant difference (p<0.0001). The knowledge of the nurses in all areas of parenteral nutrition prescription was significantly improved after the employment of mentoring method (p<0.05). Despite an increase in the post-intervention total score, the nurses' practice, before and after, the intervention was not statistically significant (p<0.05). There is a breach between nursing knowledge and practice in prescribing parenteral nutrition. The gap between knowledge and practice in this area can lead to more morbidity and negative influences on the infant. Therefore, it is required that the gap between knowledge and practice is known as the infant gets less damage.

Neuroimaging identifies increased manganese deposition in infants receiving parenteral nutrition

Manganese, an essential metal for normal growth and development, is neurotoxic on excessive exposure. Standard trace element-supplemented neonatal parenteral nutrition (PN) has a high manganese content and bypasses normal gastrointestinal absorptive control mechanisms, which places infants at risk of manganese neurotoxicity. Magnetic resonance (MR) relaxometry demonstrating short T1 relaxation time (T1R) in the basal ganglia reflects excessive brain manganese accumulation. This study tested the hypothesis that infants with greater parenteral manganese exposure have higher brain manganese accumulation, as measured by MR imaging, than do infants with lower parenteral manganese exposure. Infants exposed to parenteral manganese were enrolled in a prospective cohort study. Infants classified as having high manganese exposure received >75% of their nutrition in the preceding 4 wk as PN. All others were classified as having low exposure. Daily parenteral and enteral manganese intakes were calculated. Whole-blood manganese was measured by high-resolution inductively coupled plasma mass spectrometry. Brain MR relaxometry was interpreted by a masked reviewer. Linear regression models, adjusted for gestational age (GA) at birth, estimated the association of relaxometry indexes with total and parenteral manganese exposures. Seventy-three infants were enrolled. High-quality MR images were available for 58 infants, 39 with high and 19 with low manganese exposure. Four infants with a high exposure had blood manganese concentrations >30 μg/L. After controlling for GA, higher parenteral and total manganese intakes were associated with a lower T1R (P = 0.01) in the globus pallidus and putamen but were not associated with whole-blood manganese (range: 3.6-56.6 μg/L). Elevated conjugated bilirubin magnified the association between parenteral manganese and decreasing T1R. A short T1R for GA identifies infants at risk of increased brain manganese deposition associated with PN solutions commonly used to nourish critically ill infants. These trials were registered at clinicaltrials.gov as NCT00392977 and NCT00392730.

Percutaneous central venous catheters versus peripheral cannulae for delivery of parenteral nutrition in neonates.

Neonatal parenteral nutrition may be delivered via peripheral cannulas or central venous catheters (umbilical or percutaneous). As the result of complications associated with umbilical catheters, many neonatal units prefer to use percutaneous catheters after initial stabilisation. Although they can be difficult to place, these catheters may be more stable than peripheral cannulae and require less frequent replacement. These delivery methods may be associated with different risks of adverse events, including acquired invasive infection and extravasation injury. To determine the effects of infusion of parenteral nutrition via percutaneous central venous catheters versus peripheral cannulae on nutrient input, growth and development and complications among hospitalised neonates receiving parenteral nutrition in terms of adverse consequences such as bacteraemia or invasive fungal infection, cardiac tamponade or other extravasation injuries. We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 5), MEDLINE (1966 to June 2015) and EMBASE (1980 to June 2015), as well as conference proceedings and previous reviews. Randomised controlled trials that compared delivery of intravenous fluids (primarily parenteral nutrition) via percutaneous central venous catheters versus peripheral cannulae in hospitalised neonates. We extracted data using standard methods of the Cochrane Neonatal Group, with separate evaluation of trial quality and data extraction by two review authors. We found six trials recruiting a total of 549 infants. One trial showed that use of a percutaneous central venous catheter was associated with a smaller deficit between prescribed and actual nutrient intake during the trial period (mean difference (MD) -7.1%, 95% confidence interval (CI) -11.02 to -3.2). Infants in the percutaneous central venous catheter group needed significantly fewer catheters/cannulae (MD -4.3, 95% CI -5.24, -3.43). Meta-analysis of data from all trials revealed no evidence of an effect on the incidence of invasive infection (typical risk ratio (RR) 0.95, 95% CI 0.72 to 1.25; typical risk difference (RD) -0.01, 95% CI -0.08 to 0.06). Data from one small trial suggest that use of percutaneous central venous catheters to deliver parenteral nutrition increases nutrient input. The significance of this in relation to long-term growth and developmental outcomes is unclear. Three trials suggest that use of percutaneous central venous catheters decreases the number of catheters/cannulae needed to deliver nutrition. No evidence suggests that percutaneous central venous catheter use increases risks of adverse events, particularly invasive infection, although none of the included trials was large enough to rule out an effect on uncommon severe adverse events such as pericardial effusion.

Neonatal Outcome of the Late Preterm Infant (34 to 36 Weeks): The Singapore Story

Late preterm (LP) neonates (34 to 36 weeks gestation) are often managed like term neonates though current literature has identified them to have greater complications. The primary objective of our study was to evaluate and compare morbidity and resource utilisation in LPs especially in view of paucity of Asian studies in this regard. A retrospective audit was carried out on 12,459 neonates born in KK Women's and Children's Hospital (KKWCH). The chief outcome measures were hypoglycaemia, hypothermia, respiratory morbidity, feeding problems and neonatal jaundice. Resource utilisation included neonatal intensive care unit (NICU) admission, mechanical ventilation, parenteral nutrition and length of hospitalisation. Of 12,459 deliveries, 1221 (10%) were LP deliveries with a significantly increasing trend of 8.6% to 10% from 2002 to 2008 (P = 0.001). Neonatal morbidity in the form of hypoglycaemia (34 weeks vs 35 to 36 weeks vs term: 26% vs 16% vs 1%); hypothermia (5% vs 1.7% vs 0.2%); feeding difficulties (30% vs 9% vs 1.4%); respiratory distress syndrome (RDS) (4% vs 1% vs 0.1%); transient tachypnea of the newborn (TTNB) (23% vs 8% vs 3%) and neonatal jaundice (NNJ) needing phototherapy (63% vs 24% vs 8%), were significantly different between the 3 groups, with highest incidence in 34-week-old infants. Resource utilisation including intermittent positive pressure ventilation (IPPV) (15% vs 3.5% vs 1%), total parenteral nutrition/intravenous (TPN/IV) (53% vs 17% vs 3%) and length of stay (14 ± 22 days vs 4 ± 4.7 days vs 2.6 ± 3.9 days) was also significantly higher (P <0.001) in LPs. LP neonates had significantly higher morbidity and resource utilisation compared to term infants. Among the LP group, 34-week-old infants had greater complications compared to infants born at 35 to 36 weeks.

High Protein Intake Does Not Prevent Low Plasma Levels of Conditionally Essential Amino Acids in Very Preterm Infants Receiving Parenteral Nutrition.

We have shown that increasing protein intake using a standardized, concentrated, added macronutrients parenteral (SCAMP) nutrition regimen improves head growth in very preterm infants (VPIs) compared with a control parenteral nutrition (PN) regimen. VPIs are at risk of conditionally essential amino acid (CEAA) deficiencies because of current neonatal PN amino acid (AA) formulations. We hypothesized that the SCAMP regimen would prevent low plasma levels of CEAAs. To compare the plasma AA profiles at approximately day 9 of life in VPIs receiving SCAMP vs a control PN regimen. VPIs (<29 weeks' gestation) were randomized to receive SCAMP (30% more PN AA) or a control regimen. Data were collected to measure parenteral and enteral protein, energy, and individual AA intake and the first plasma AA profile. Plasma profiles of the 20 individual protogenic AA levels were measured using ion exchange chromatography. Plasma AA profiles were obtained at median (interquartile range [IQR]) age of 9 (8-10) days in both SCAMP (n = 59) and control (n = 67) groups after randomizing 150 VPIs. Median (IQR) plasma levels of individual essential AAs were higher than the reference population mean (RPM) in both groups, especially for threonine. SCAMP infants had higher plasma levels of essential AAs than did the controls. Median (IQR) plasma levels of glutamine, arginine, and cysteine (CEAAs) were lower than the RPM in both groups. Plasma AA levels in PN-dependent VPIs indicate there is an imbalance in essential and CEAA provision in neonatal PN AA formulations that is not improved by increasing protein intake.

Double blind exploratory study on de novo lipogenesis in preterm infants on parenteral nutrition with a lipid emulsion containing 10% fish oil

Provision of long chain polyunsaturated fatty acids (LCP) both of the omega-3 and omega-6 families is recommended for preterm infants (PI). Fish oil (FO) contains omega-3 and omega-6 LCP and it is incorporated in the fat blend of the new generation lipid emulsions (LE). Omega-3 LCP have been shown to reduce the expression of genes involved in lipogenesis, which could be important for several organs development. The aim of this study was to ascertain if the use of intravenous FO has an effect on lipogenesis in PI. Forty PI were randomized to receive two LE: MSF (50:40:10 Medium Chain Triglycerides (MCT): Soybean oil (SO): FO) or MS (50:50 MCT:SO). We measured plasma lipids on day 7 and the fractional and absolute synthesis rates (FSR and ASR) of cholesterol and of selected fatty acids (FA) after (2)H2O body water labeling. Plasma phospholipids (PL), free cholesterol (FC), and cholesterol esters (CE) concentrations were all lower in MSF than in MS. In spite of lower plasma FC and CE concentrations, cholesterol biosynthesis was similar between the two study groups (FC: FSR 16.0±1.4 vs 14.1±1.1%/d, p=0.74; ASR 6.8±0.6 vs 7.1±0.6mgkg(-1)d(-1), p=0.93; CE: FSR 3.6±0.5 vs 4.2±0.4%/d, p=0.38; ASR: 3.3±0.4 vs 4.4±0.5mgkg(-1)d(-1), p=0.13, in MSF and MS respectively). FSR and ASR of selected FA were, or tended to be, lower in MSF than in MS. ASR of PL palmitate (4.0±0.3 vs 4.8±0.4mgkg(-1)d(-1), p=0.045), PL oleate (0.2±0.04 vs 0.4±0.05mgkg(-1)d(-1), p=0.02) and CE oleate (0.5±0.1 vs 0.9±0.1mgkg(-1)d(-1), p=0.03) were significantly lower in MSF than in MS. There were no differences in plasma TG FA biosynthesis. Cholesterol biosynthesis was not affected by 10% FO during neonatal parenteral nutrition. Ten percent FO caused a statistically significant reduction in the lipogenesis of selected FA and an overall tendency towards a reduced lipogenesis. The magnitude seems to be limited and the biological significance is unknown. Our data warrant follow-up studies in PI who receive intravenous FO, especially in those infants who receive larger doses than in the present study. Since this trial started in 2007, trial registration was not required.

Three-in-one parenteral nutrition in neonates and pediatric patients: risks and benefits.

Parenteral nutrition (PN) is a life-sustaining therapy designed to deliver essential nutrients to patients unable to meet nutrition needs via the enteral route. PN may be delivered via a 2-in-1 system (one solution containing amino acids, dextrose, electrolytes, vitamins, minerals, and fluids and one solution containing intravenous fat emulsions [IVFEs]) or via a 3-in-1 system (all nutrients mixed in one container). Although the use of 3-in-1 PN solutions is not necessarily therapeutically advantageous, certain benefits may exist such as the potential to reduce the risk of contamination due to decreased manipulations; ease of administration, particularly in the home care setting; possible cost savings; and reduced IVFE wastage. However, the incorporation of IVFE in 3-in-1 solutions also presents unique risks for the neonatal and pediatric population such as decreased stability, increased lipid globule size, decreased sterility and the potential for increased microbial growth/infectious complications, the need to use a larger filter size, precipitation and compatibility risks, and an increased chance of catheter occlusion. This review outlines the unique issues and challenges to be considered when formulating neonatal and pediatric 3-in-1 PN admixtures. While 3-in-1 PN solutions may be advantageous for certain pediatric populations, specifically those dependent on home PN, the risks do not outweigh the benefits in neonatal patients, and use should be avoided in this population.

In Vitro Assessment of Interaction Between Amino Acids and Copper in Neonatal Parenteral Nutrition.

The repeated blackening of in-line filters has been observed during the infusion of parenteral nutrition 2-in-1 mixtures (binary parenteral nutrition [BPN]) delivered in a neonatal intensive care unit. This study aimed to examine the elemental content of precipitates isolated from infused BPN bags and determine the main physicochemical interactions occurring in these bags. The infusion of BPN mixtures was simulated in vitro following hospital practices. Filter membranes were examined by scanning electron microscopy and energy dispersion spectroscopy (EDS). Amino acid (AA) profiles were obtained from BPN mixtures to determine the concentrations of each AA. Analyzed filter membranes revealed conglomerates of particles on filter surfaces. An EDS analysis generated spectra from isolated particles, identifying copper and sulfur as the major chemical elements. AA mean concentrations were relatively close to the expected value for each AA, except cysteine. Cysteine concentrations were very significantly lower than the expected values. A specific interaction was identified between 1 AA (cysteine) and a trace element (copper) in our BPN mixtures.

Concentrated parenteral nutrition solutions and central venous catheter complications in preterm infants

Standardised, concentrated neonatal parenteral nutrition (PN) regimens can overcome early nutritional deficits in very preterm infants. A PN regimen with increased macronutrient content (standardised, concentrated, added macronutrients parenteral (SCAMP)) has...

PO-0586 Hyperalimentation And Plasma Levels Of Amino Acids In Very Preterm Infants Dependent On Parenteral Nutrition: Abstract PO-0586 Table 1

Background The standardised, concentrated with added macronutrients parenteral (SCAMP) nutrition regimen provides hyperalimentation to very preterm infants (VPI). Current neonatal parenteral nutrition (PN) amino acid (AA) formulations predate recent recommended protein intakes. AA were categorised as essential, conditionally essential (in VPI) and non-essential. We hypothesised hyperalimentation would prevent low plasma levels of conditionally essential AA (CEAA). Methods Infants ( Results Infants were randomised to SCAMP (n = 74) and control (n = 76) groups. The mean difference (95% confidence interval) in total protein intake (g/kg) was 8.7 (6.0–11.5) d1–28. All essential AAs (phenylalanine, lysine, valine, leucine, isoleucine, methionine, threonine, histidine and tryptophan) were within or above the reference range (RR) in both groups. Plasma arginine/cysteine levels (week 2) were below RR in both SCAMP (n = 45) and control (n = 62) infants (Table 1). Plasma cysteine levels (week 3) were below RR in both SCAMP (n = 39) and control (n = 36) infants. Conclusion Despite hyperalimentation and increased protein intake, PN-dependent VPI remain biochemically deficient in some conditionally essential AAs.

Calcium Chloride in Neonatal Parenteral Nutrition: Compatibility Studies Using Laser Methodology

IntroductionWe have previously reported results of precipitation studies for neonatal parenteral nutrition solutions containing calcium chloride and sodium phosphate using visual methods to determine compatibility. The purpose of this study was to do further testing of compatibility for solutions containing calcium chloride using more sensitive methods.MethodsSolutions of Trophamine (Braun Medical Inc, Irvine, CA) and Premasol (Baxter Pharmaceuticals, Deerfield, IL) were compounded with calcium chloride and potassium phosphate. Controls contained no calcium or phosphate. After incubation at 37° for 24 hours solutions without visual precipitation were analyzed to determine mean particle size using dynamic light scattering from a laser light source.ResultsParticle sizes were similar for control solutions and those without visual precipitation and a mean particle size <1000 nm. Compatible solutions were defined as those with added calcium and phosphate with no visual evidence of precipitation and mean particle size <1000 nm. In solutions containing 2.5–3% amino acids and 10 mmol/L of calcium chloride the maximum amount of potassium phosphate that was compatible was 7.5 mmol/L.ConclusionMaximum amounts of phosphate that could be added to parenteral nutrition solutions containing Trophamine and calcium chloride were about 7.5–10 mmol/L less for a given concentration of calcium based upon laser methodology compared to visual techniques to determine compatibility. There were minor differences in compatibility when adding calcium chloride and potassium phosphate to Premasol versus Trophamine.

Using failure mode and effects analysis to improve the safety of neonatal parenteral nutrition.

Failure mode and effects analysis (FMEA) was used to identify potential errors and to enable the implementation of measures to improve the safety of neonatal parenteral nutrition (PN). FMEA was used to analyze the preparation and dispensing of neonatal PN from the perspective of the pharmacy service in a general hospital. A process diagram was drafted, illustrating the different phases of the neonatal PN process. Next, the failures that could occur in each of these phases were compiled and cataloged, and a questionnaire was developed in which respondents were asked to rate the following aspects of each error: incidence, detectability, and severity. The highest scoring failures were considered high risk and identified as priority areas for improvements to be made. The evaluation process detected a total of 82 possible failures. Among the phases with the highest number of possible errors were transcription of the medical order, formulation of the PN, and preparation of material for the formulation. After the classification of these 82 possible failures and of their relative importance, a checklist was developed to achieve greater control in the error-detection process. FMEA demonstrated that use of the checklist reduced the level of risk and improved the detectability of errors. FMEA was useful for detecting medication errors in the PN preparation process and enabling corrective measures to be taken. A checklist was developed to reduce errors in the most critical aspects of the process.

A Filtration System That Greatly Reduces Aluminum in Calcium Gluconate Injection, USP Used to Prepare Parenteral Nutrition Solutions.

The study objective was to reduce aluminum (Al) in Calcium Gluconate Injection, US Pharmacopeia (USP) used in the preparation of parenteral nutrition (PN) solutions. A flow-through filter containing an immobilized chelator that complexes Al from Calcium Gluconate Injection, USP as it flows through the filter was designed, refined by design modifications, and extensively tested. When a small-volume parenteral vial containing 100 mL of Calcium Gluconate Injection, USP is connected on the inlet side of the filter, and the outlet side is connected to an evacuated receiving vial, the filtered solution is drawn into the receiving vial. This constitutes a complete system to remove Al from Calcium Gluconate Injection, USP. The extent of Al removal is flow rate dependent. At a flow rate of 1 mL/min approximately 85% of the Al was removed from calcium gluconate solution. PN solutions have been reported to deliver 15 to 23 mcg/kg/day Al to neonates. Given that Calcium Gluconate Injection, USP provides 85% of the Al in neonatal PN solutions, removal of 85% of the Al from this source was calculated to reduce Al delivered to most neonates to <5 mcg/kg/day. A point-of-use, self-contained, single-use, disposable, Al-complexing filter has been created. It was calculated to reduce Al delivered in PN solutions by 72%, resulting in daily Al delivery below the level that results in Al accumulation associated with central nervous system and bone toxicity to all but the smallest (<1 kg) infants.