Neonatal Parenteral Nutrition Research Articles

Impact of SMOFlipid on Clinical Outcomes in Neonates Receiving Parenteral Nutrition: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Aims/Background Neonatal morbidity, including various diseases such as sepsis, cholestasis, and bronchopulmonary dysplasia (BPD), is a significant concern, especially in preterm infants. Selecting the appropriate lipid emulsion in parenteral nutrition (PN) is essential to improve clinical outcomes. This analysis aimed to assess the impact of a novel composite lipid emulsion, SMOFlipid, on neonates receiving PN. Methods A systematic review and meta-analysis of randomized controlled trials (RCTs) were conducted. We compared SMOFlipid to various other lipid emulsions in PN received by infants. Research findings that addressed outcomes such as mortality, sepsis, cholestasis, necrotizing enterocolitis (NEC), BPD, patent ductus arteriosus (PDA), retinopathy of prematurity (ROP), intraventricular hemorrhage (IVH), and length of hospital stay were included. Subgroup analyses were conducted based on gestational age (GA). Twenty RCTs involving 1904 neonates were included. Results Compared to other lipid emulsions, SMOFlipid significantly reduced the cholestasis risk (risk ratio (RR): 0.65, 95% confidence interval (CI): 0.48-0.87, p = 0.004, I2 = 0%). However, the incidence related to IVH, BPD, ROP, NEC, and PDA (excluding an infant subgroup with GA <28 weeks), mortality, sepsis, and duration of hospital stay did not exhibit any substantial variations. The subgroup analysis indicated a decline in PDA incidence (RR: 0.88, 95% CI: 0.79-0.99, p = 0.04, I2 = 0%) among extremely premature infants receiving SMOFlipid. Conclusion SMOFlipid offers a promising option for neonatal PN, particularly for reducing cholestasis in preterm infants and PDA in extremely premature infants. Further investigations into its comprehensive benefits and long-term effects are warranted.

Automation of parenteral nutrition: impact on process and cost analysis

ObjectivesOn the basis of its safety and accuracy, automation is recommended for parenteral nutrition (PN). The aim of this study was to highlight the changes in practices related to the...

Evaluation of the clinical impact of decreasing the maximum osmolarity of neonatal peripheral parenteral nutrition.

To describe the clinical impact of lowering the peripheral parenteral nutrition (PPN) maximum osmolarity limit from 1000to 900 mOsm/L in patients in two neonatal intensive care units (NICUs). This was a retrospective cohort study including inborn neonates that received PPN for at least 3 consecutive days within the first 14 days of life. Data were evaluated to compare the ability of PPN with a maximum osmolarity limit of 1000to 900 mOsm/L to provide daily recommended macronutrient doses, anddaily recommended goal calories, as well as to compare the incidence of significant peripheral intravenous (PIV) infiltrates. A total of 200 PPN orders representing 57 patients were included for analysis, with 100 PPN orders in each osmolarity cohort. Baseline characteristics were similar between the two cohorts. Significantly more PPN orders met goal amino acid doses (45% vs. 24%, p = 0.003) and goal intravenous fat emulsion (IVFE) doses (61% vs. 37%, p = 0.001) in the 1000 mOsm/L osmolarity limit cohort compared to the 900 mOsm/L osmolarity limit cohort. A total of three patients received hyaluronidase for PN infiltration, two in the 1000 mOsm/L osmolarity limit and one in the 900 mOsm/L osmolarity limit cohort (p = 0.6). A lower PPN osmolarity limit of 900 mOsm/L significantly limited the ability to provide goal amino acid and IVFE doses to NICU patients compared to the previous osmolarity limit of 1000 mOsm/L without reducing the incidence of PIV infiltration or extravasation.

A Retrospective Study Evaluating Guideline Adherence of Neonatal Parenteral Nutrition in a Belgian Neonatal Intensive Care Unit.

Introduction Clinical nutrition for preterm and critically ill neonates remains a challenge. Preterms are often hemodynamically and metabolically compromised, which limits infusion volumes of nutrients and hinders achieving recommended nutrient intakes. While guidelines provide recommended ranges for parenteral nutrition (PN) intakes, they generally recommend enteral nutrition as soon as possible. Thus, in clinical practice, gradually increasing EN intakes complicates assessments of PN guideline adherence. Via a pragmatic approach, we assessed adherence to PN recommendations for macronutrients and energy as stated in the 2018 guidelines of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN). Methods In this retrospective study, we assessed the nutrition of preterm and critically ill term neonates from the neonatal intensive care unit of the University Hospital Brussels. We analyzed intakes for the first week of life, in which critically ill neonates at our center usually receive the majority of nutrients via PN. The PN-based provision of macronutrients and energy was analyzed descriptively in relation to the ESPGHAN 2018 recommendations. Results Macronutrients and energy provision gradually increased until they reached recommended or targeted values. Compared to term neonates, energy and lipid provision for preterms increased faster, while amino acid provision exceeded the ESPGHAN 2018 recommendations. Conclusions This study adds clinical practice data to the severely understudied field of the ESPGHAN 2018 PN guideline compliance. Using a pragmatic assessment of our nutrition protocols, we found the need to reduce the amount of amino acids per kg body weight per day to meet guideline recommendations.

An Ex Vivo Study Examining Migration of Microplastics from an Infused Neonatal Parenteral Nutrition Circuit.

An Ex Vivo Study Examining Migration of Microplastics from an Infused Neonatal Parenteral Nutrition Circuit.

Construction and evaluation of neonatal respiratory failure risk prediction model for neonatal respiratory distress syndrome

BackgroundNeonatal respiratory distress syndrome (NRDS) is a common respiratory disease in preterm infants, often accompanied by respiratory failure. The aim of this study was to establish and validate a nomogram model for predicting the probability of respiratory failure in NRDS patients.MethodsPatients diagnosed with NRDS were extracted from the MIMIC-iv database. The patients were randomly assigned to a training and a validation cohort. Univariate and stepwise Cox regression analyses were used to determine the prognostic factors of NRDS. A nomogram containing these factors was established to predict the incidence of respiratory failure in NRDS patients. The area under the receiver operating characteristic curve (AUC), receiver operating characteristic curve (ROC), calibration curves and decision curve analysis were used to determine the effectiveness of this model.ResultsThe study included 2,705 patients with NRDS. Univariate and multivariate stepwise Cox regression analysis showed that the independent risk factors for respiratory failure in NRDS patients were gestational age, pH, partial pressure of oxygen (PO2), partial pressure of carbon dioxide (PCO2), hemoglobin, blood culture, infection, neonatal intracranial hemorrhage, Pulmonary surfactant (PS), parenteral nutrition and respiratory support. Then, the nomogram was constructed and verified.ConclusionsThis study identified the independent risk factors of respiratory failure in NRDS patients and used them to construct and evaluate respiratory failure risk prediction model for NRDS. The present findings provide clinicians with the judgment of patients with respiratory failure in NRDS and help clinicians to identify and intervene in the early stage.

Stability of individualized neonatal parenteral nutrition admixtures with fish oil and high calcium content.

Introduction: the stability of total parenteral nutrition admixtures for neonates (TPNAn) has been questioned in relation to the interaction between calcium and fish oil emulsions. Aim: the aim of this study was to check the stability (particle size < 1 µm) of different individualized TPNAn prepared with fish-oil emulsion and containing calcium at concentrations ranging from 10 to 20 mmol/L. Methods: admixtures analyzed: twelve different formulations with SMOFlipid® 20 % (conserved for 24 h and for 96 h), three formulations with Lipoplus® 20 % (conserved for 96 h) and three formulations with SMOFlipid® 20 % with Multi-12K1® Pediatric (conserved for 96 h). Two bags were compounded for each formulation and conservation period. Measurements on each admixture bag: particle standardized diameter by laser diffraction technique and pH by a calibrated pH-meter. Data analysis with mixed linear regression models. Results: maximum particle size was < 0.8 µm for all investigated admixtures. Lipid concentration of 5 g/L and sodium and potassium concentration of 100 mmol/L slightly increased the proportion of particles > 0.6 µm. Ninety six hours storage also increased the percentage of particles > 0.6 µm (+0.143 ± 0.07; p = 0.038) but did not influence other parameters. No association with calcium composition was observed. Amino acid content was inversely correlated with pH (-0.83; p < 0.0001). Conclusions: the studied individualized parenteral nutrition admixtures for newborns that contain fish oil emulsions and meet cation requirements are stable for at least 96 hours.

An Assessment of aluminum contamination in neonatal parenteral nutrition solutions based on measured versus labeled content

Aluminum can potentially cause toxicity in pediatrics and neonates receiving parenteral nutrition. Some PN solutions and ingredients in Saudi Arabia do not comply with US FDA regulations regarding aluminum exposure. This study aims to determine the aluminum concentration in samples of PN solutions and ingredients used to feed infants in Saudi Arabia. The aluminum in the samples was determined using inductively coupled plasma mass spectrometry. The concentration of metal contaminants in each sample was determined in triplicate. The aluminum content of 38 samples was investigated, 15 of which originated from components included in the prepared PN solutions. Among the 15 samples, the least measurable aluminum content was detected in potassium chloride solutions (0.81 mcg/L). In contrast, the greatest amount of aluminum was detected in potassium phosphate and calcium gluconate (141,64 mcg/L and 462.7 mcg/L), respectively. The results showed that the final PN solution (PNS) product contained more aluminum levels than the content ingredients; in addition, the study found a statistically significant relationship among 18 pediatric patients at KFMC who had intestinal failure and needed long-term parenteral nutrition. Specifically, their high aluminum levels, exceeding the normal range of 0.6 ng/ml, indicate that the current use of PN solutions will likely cause toxicity due to aluminum contamination in additives. Hence, reducing aluminum in PN solutions is imperative to ensure patient safety.

Altered hepatic and intestinal homeostasis in a neonatal murine model of short-term total parenteral nutrition and antibiotics.

Parenteral nutrition (PN) prevents starvation and supports metabolic requirements intravenously when patients are unable to be fed enterally. Clinically, infants are frequently provided PN in intensive care settings along with exposure to antibiotics (ABX) to minimize infection during care. Unfortunately, neonates experience extremely high rates of hepatic complications. Adult rodent and piglet models of PN are well-established but neonatal models capable of leveraging the considerable transgenic potential of the mouse remain underdeveloped. Utilizing our newly established neonatal murine PN mouse model, we administered ABX or controlled drinking water to timed pregnant dams to disrupt the maternal microbiome. We randomized mouse pups to PN or sham surgery controls +/- ABX exposure. ABX or short-term PN decreased liver and brain organ weights, intestinal length, and mucosal architecture (vs. controls). PN significantly elevated evidence of hepatic proinflammatory markers, neutrophils and macrophage counts, bacterial colony-forming units, and evidence of cholestasis risk, which was blocked by ABX. However, ABX uniquely elevated metabolic regulatory genes resulting in accumulation of hepatocyte lipids, triglycerides, and elevated tauro-chenoxycholic acid (TCDCA) in serum. Within the gut, PN elevated the relative abundance of Akkermansia, Enterococcus, and Suterella with decreased Anaerostipes and Lactobacillus compared with controls, whereas ABX enriched Proteobacteria. We conclude that short-term PN elevates hepatic inflammatory stress and risk of cholestasis in early life. Although concurrent ABX exposure protects against hepatic immune activation during PN, the dual exposure modulates metabolism and may contribute toward early steatosis phenotype, sometimes observed in infants unable to wean from PN.NEW & NOTEWORTHY This study successfully established a translationally relevant, murine neonatal parenteral nutrition (PN) model. Short-term PN is sufficient to induce hepatitis-associated cholestasis in a neonatal murine model that can be used to understand disease in early life. The administration of antibiotics during PN protects animals from bacterial translocation and proinflammatory responses but induces unique metabolic shifts that may predispose the liver toward early steatosis.

Stability Testing of Modified Amino Acid Solutions in Neonatal Parenteral Nutrition Formulations

ABSTRACT Context: Aqueous neonatal parenteral nutrition (PN) formulations are made up of glucose, amino acids (AAs), and electrolytes. Different AA solutions are used to make these formulations. Most licensed products do not meet the nutritional needs of preterm neonates specifically for arginine. Therefore, AA solutions with additional arginine need to be developed and proven stable before being tested for clinical efficacy. PN formulations containing modified AA solutions with 15% arginine were tested in this study. Aims: This study aims to design a stability testing protocol and assign a shelf life to the modified PN formulations being tested. Methods: Physical tests including appearance, pH, optical rotation, ultraviolet absorbance, and subvisible particle count tests as well as chemical analysis using AA assay were performed in this study. Results: Resampling of PN bag samples posed a risk for oxidation and hence single sampling of fresh PN bags for each test point is the best practice for PN stability testing trials. AA assay is a feasible method to ensure AA stability in PN formulations. Conclusion: Modified PN formulations with 15% arginine were stable for 90 days without the addition of the trace element solution. Upon the addition of trace elements, the shelf life was limited to 7 days.

Negative Outcomes Associated with Medication in Neonates on Parenteral Nutrition Therapy

Objective: In Ecuador, studies on clinical daily practice problems focused on parenteral nutrition in neonates are scarce. Therefore, this research aimed to identify negative results associated with medications (NRAM) in neonates with parenteral nutrition (PN) in a third-level hospital in Ecuador. Material and methods: An observational, prospective, descriptive study was designed in the neonatology area of a tertiary-level public hospital, where, for over four months, the medical records, PN prescriptions, and pharmacy-managed databases of 78 patients were analyzed. Drug-related problems (DRPs) as possible causes of NRAM were classified through administrative, physicochemical, and clinical validation. Results: DRPs classified as follows were found: 78.81% by physicochemical, 17.62% by clinical, and 3.57% by administrative validation. The NRAM were 72% quantitatively uncertain, 16% needed, and 11% quantitatively ineffective. Conclusion: The NRAM associated with DRPs were statistically related to prematurity condition, APGAR score, PN time, and the number of medications administered, which suggests the need to create a nutritional therapy committee at the health facility.

Assessment of the Adherence to ESPGHAN 2018 Guidelines in the Neonatal Intensive Care Unit of the Ghent University Hospital: A Retrospective Study.

Parenteral nutrition (PN) is a standard of care for preterm infants in the first postnatal days. The European Society of Paediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) has updated their guideline recommendations on PN in 2018. However, data on actual 2018 guideline adherence in clinical practice are sparse. In this retrospective study, conducted at the neonatal intensive care unit (NICU) of Ghent University Hospital, we analyzed the ESPGHAN 2018 PN guideline adherence and growth for 86 neonates admitted to the NICU. Analyses were stratified by birth weight (<1000 g, 1000 to <1500 g, ≥1500 g). We documented the provisions for enteral nutrition (EN) and PN, and we tested the combined EN and PN provisions for ESPGHAN 2018 adherence. The nutrition protocols showed a high adherence to PN guidelines in terms of carbohydrate provisions, yet lipid provisions for EN and PN often exceeded the recommended maximum of 4 g/kg/d; although, PN lipid intakes maxed out at 3.6 g/kg/d. Protein provisions tended to fall below the recommended minimum of 2.5 g/kg/d for preterm infants and 1.5 g/kg/d for term neonates. The energy provisions also tended to fall below the minimum recommendations, especially for neonates with a birth weight (BW) < 1000 g. Over a mean PN duration of 17.1 ± 11.4 d, the median weekly Fenton Z-scores changes for length, weight, and head circumference were positive for all BW groups. Future studies have to assess how protocols adapt to current guidelines, and how this affects short- and long-term growth across different BW groups. In conclusion, the reported findings provide real-world evidence regarding the effect of ESPGHAN 2018 PN guideline adherence, and they demonstrate how standardized neonatal PN solutions can safeguard stable growth during NICU stays.

Mucous fistula refeeding in neonates: a systematic review and meta-analysis

Background and objectiveMucous fistula refeeding (MFR) aims to maximise bowel function when an ostomy is active after abdominal surgery, by introducing the proximal ostomy effluent into the distal mucous fistula...

Physical compatibility of medications with concentrated neonatal and pediatric parenteral nutrition: A simulated Y-site drug compatibility study.

The physical intravenous Y-site compatibility of 15 different medications with highly concentrated neonatal and pediatric parenteral nutrition (PN) compounds is described, using existing and novel methods. PN formulations were developed based on common prescribing practices in a 400+-bed freestanding children's hospital. Medications at commonly used pediatric concentrations were mixed in a 1:1 ratio with both pediatric and neonatal PN formulations and incubated at room temperature for 4 h to simulate Y-site administration. Samples were then analyzed using the light obscuration (LO) technique, as recommended by United States Pharmacopeia (USP) chapter 788, in addition to novel flow imaging (FI) microscopy and backgrounded membrane imaging (BMI). Physical compatibility was determined using USP 788 particle count limits for all techniques. Most combinations were found to be compatible per USP 788 thresholds. Pediatric PN was incompatible by at least two methods with cisatracurium 2 mg/ml, sildenafil 0.8 mg/ml, furosemide 10 mg/ml, and ketamine 10 mg/ml. Neonatal PN was incompatible by at least two methods with cisatracurium 2 mg/ml and furosemide 10 mg/ml. Overall, results for 20 of the 30 combinations (66%) agreed across all three methods. FI and BMI results agreed for 22 of 30 combinations. LO agreed with FI in 25 of 30 combinations, and BMI and LO results agreed in 23 of 30 combinations. Most combinations tested were found to be compatible across all methods. Novel methods of FI and BMI seem useful to further evaluate LO findings and improve accuracy of particle counts when assessing PN-medication combinations.

Retracted: Data Mining-Based Stability and Prescription Analysis of Neonatal Parenteral Nutrition Solution.

[This retracts the article DOI: 10.1155/2021/5744656.].

Neonatal exposure to phthalate and alternative plasticizers via parenteral nutrition

Di-(2-ethylhexyl) phthalate (DEHP), a plasticizer used to soften plastic medical devices (PMDs), was restricted in PMDs due to adverse health effects, being gradually replaced by alternative plasticizers (APs). Parenteral nutrition (PN), essential in the care for premature neonates in the neonatal intensive care unit, is stored in plastic storage bags and administered intravenously through plastic infusion circuits. We investigated to which extent PN contributes to current phthalate and AP exposure in premature neonates. First, we showed that DEHP and several APs are present in relevant amounts in PMDs used for neonatal PN administration. Secondly, ex vivo experiments mimicking clinical PN administration showed that lipid emulsions contained significant concentrations of DEHP and several APs (ATBC, TOTM, DEHT & DEHA), while hardly any plasticizers were detected in non-lipid solutions. ATBC leached from infusion circuits, while lipid emulsions were the major source for DEHP, TOTM, DEHT, and DEHA. PN administration resulted in estimated daily exposures of 13.9 µg/kg/d DEHP and 95.7 µg/kg/d ATBC in premature neonates, below their respective reference doses. Our data indicate that premature neonates requiring PN are still exposed to DEHP, as well as to a range of APs, making it a target for reduction of harmful plasticizer exposure.

Application Protocol of Standardized Neonatal Parenteral Nutrition Formulations

With the improvements in medical technology, more premature infants and infants with congenital intestinal malformations or other conditions who need parenteral nutrition (PN) support can survive. PN technology has become an important therapeutic strategy in neonatal intensive care units. Due to differences in the qualifications of medical staffs, hospital pharmacy management, hospital level, etc, the composition and preparation methods of PN prescription vary greatly in different regions and hospitals in China. In addition, delays in the starting time of PN, unreasonable formula of nutrition components, poor prescription review, large workload involved in the preparation of PN for nurses, and waste of drugs are prone to happen. In view of these issues, our hospital independently developed standardized formulas of neonatal PN solution, which has been approved in Australia as a patented invention. Herein, we reported the composition and application protocol of this standardized PN solution for newborns.

Neonatal Antibiotic Treatment Can Affect Stool Pattern and Oral Tolerance in Preterm Infants.

Preterm neonates are at high risk of infectious and inflammatory diseases which require antibiotic treatment. Antibiotics influence neonatal gut microbiome development, and intestinal dysbiosis has been associated with delayed gastrointestinal transit. Neonates who take less time to pass meconium have a better tolerance to enteral feeding. We analyzed the effect of neonatal antibiotic treatment on the stool pattern and oral tolerance in 106 preterm infants < 33 weeks gestational age. Neonates were classified in 3 groups according to neonatal antibiotic (ABT) treatment days: no antibiotics, 3–7 d ABT, and ≥8 d ABT. Preterm infants from the ≥8 d ABT group took longer to pass meconium and to start green and yellow stools, took longer to reach 100 and 150 mL/kg/day, and reached reduced volumes in enteral feeds at day of life 14 and 28 than infants from no ABT and 3–7 d ABT groups. Multiple linear regression models showed that neonatal antibiotic treatment, birth weight, invasive mechanical ventilation, surfactant, enteral feeding start day, neonatal parenteral nutrition, and neonatal fasting days are associated with the stool pattern and oral tolerance in preterm infants.

Introduction of standardised parenteral nutrition for paediatric and neonatal patients using multichamber bags - an impact assessment on aseptic services capacity

Traditionally, paediatric and neonatal parenteral nutrition (PN) has been prescribed as a bespoke product, which was compounded in-house or outsourced from commercial providers. Due to limited stability of the admixtures, the majority of prescriptions were compounded into two containers - a lipid syringe / bag containing lipid and vitamins, plus an aqueous bag for amino acids, glucose, electrolytes and trace elements. In this large specialist children’s hospital a limited number of older / larger patients were prescribed a multi chamber bag (MCB), either whole or part as appropriate to their needs.

Assessment of the Complications of Peripherally Inserted Central Catheter in Neonates Admitted to the Intensive Care Unit: A Center's Experience in Iran.

Peripherally Inserted Central Catheter (PICC), which is inserted through peripheral veins into the superior or inferior vena cava, is used to inject medications or parenteral nutrition in neonates with long-term hospitalization in the intensive care unit. In this study, we assessed the complications of PICC in neonates admitted to the intensive care unit in hospital. In the present retrospective cohort, neonates admitted to the Neonatal Intensive Care Unit (NICU) of Valiasr Hospital during 2015-2018 had been divided into two groups with PICC and without it. Data included the occurrence of septicemia, tachycardia, perforation of large veins, pulmonary hypertension, cardiac tamponade, pericardial effusion, catheter site necrosis, hemorrhage, anemia, pleural effusion, ascites, phlebitis of catheter track and neonatal death, which were collected, using the comprehensive neonatal registry of Valiasr Hospital. Data analysis was performed with regression, mantel-haenszel and independent t-test. Data from 174 neonates with PICC were compared to 207 infants with classic IV-Line. In the exposure group, the gestational age and birth weight were lower. Based on the results of the double logistic regression test, septicemia and hemorrhage in the injection site, independent of other variables, were related to the use of PICC and the risk of septicemia or hemorrhage in the injection site was significantly reduced if PCIC was used (p < 0.01). Using the PICC as a therapeutic procedure in hospitalized neonates in the NICU is a safe method. By improving its replacement skills among physicians and nurses, its side effects are minor and negligible.