Managing Undernutrition in Pediatric Oncology: A Consensus Statement Developed Using the Delphi Method by the Polish Society for Clinical Nutrition of Children and the Polish Society of Pediatric Oncology and Hematology.

"Managing Undernutrition in Pediatric Oncology" is a collaborative consensus statement of the Polish Society for Clinical Nutrition of Children and the Polish Society of Pediatric Oncology and Hematology. The early identification and accurate management of malnutrition in children receiving anticancer treatment are crucial components to integrate into comprehensive medical care. Given the scarcity of high-quality literature on this topic, a consensus statement process was chosen over other approaches, such as guidelines, to provide comprehensive recommendations. Nevertheless, an extensive literature review using the PubMed database was conducted. The following terms, namely pediatric, childhood, cancer, pediatric oncology, malnutrition, undernutrition, refeeding syndrome, nutritional support, and nutrition, were used. The consensus was reached through the Delphi method. Comprehensive recommendations aim to identify malnutrition early in children with cancer and optimize nutritional interventions in this group. The statement underscores the importance of baseline and ongoing assessments of nutritional status and the identification of the risk factors for malnutrition development, and it presents tools that can be used to achieve these goals. This consensus statement establishes a standardized approach to nutritional support, aiming to optimize outcomes in pediatric cancer patients.

Pediatric endoscopy in times of pandemic: A nationwide retrospective analysis.

BACKGROUND: Gastrointestinal endoscopy is a procedure that carries an increased risk of transmission of SARS-CoV-2 infection to medical staff. In patients, COVID-19 is a risk factor for adverse events of medical procedures. This study analyzed the real-life risk of, and factors contributing to, infection transmission to endoscopic personnel, and possible adverse events of the endoscopy procedure and anesthesia in children with COVID-19. METHODS: Nationwide retrospective analysis of medical records of children with confirmed SARS-CoV-2 infection who underwent gastrointestinal endoscopy in Poland between February 2020 and February 2022. RESULTS: Fifty-eight patients were included in the analysis, 35% of whom had COVID-19 symptoms at the time of endoscopy. The dominant indications for endoscopy were foreign body or corrosive substance ingestion and gastrointestinal bleeding. Nine cases of virus transmission were registered among endoscopic personnel. In all of these cases, the endoscopy team was unaware of the patient's infection (p < 0.01), although symptoms were present in 78% of the children. Lack of use of personal protective equipment was the strongest predictor of SARS-CoV-2 transmission (p < 0.01). The risk of infection was not statistically significantly dependent on the method of anesthesia, intubation or the type of endoscopy. No statistically significant correlation was found between symptomatic infection and adverse events of endoscopy or anesthesia occurrence. There was one reported anesthesia-related adverse event involving extubation difficulties due to worsening respiratory infection symptoms. CONCLUSIONS: The risk of transmitting SARS-CoV-2 to endoscopic personnel during procedures in children is low and depends on compliance with infection prevention and control measures. Performing gastrointestinal endoscopy in children with COVID-19 does not appear to be associated with an increased risk of adverse events.

Continuous Glucose Monitoring in Enterally Fed Children with Severe Central Nervous System Impairment.

Children with severe central nervous system (CNS) impairment are at risk of developing various degrees of nutritional deficit that require long-term nutritional intervention. Interventions are most often implemented through enteral nutrition (EN) using commercially manufactured feeds administered via gastro/jejunostomy or nasogastric or nasojejunal tubes. The modality of feeding-continuous feeding or bolus feeding-is dependent on the function of the gastrointestinal tract, particularly the efficiency of gastric emptying. In the literature, the relationship between this type of nutrition and the occurrence of hyperglycaemia is often discussed. In addition, children with chronic neurological diseases are vulnerable to disorders of many mechanisms of neurohormonal counter-regulation related to carbohydrate management, and due to limited verbal and logical contact, it is difficult to recognise the symptoms of hypoglycaemia in such patients. We aimed to assess the carbohydrate metabolism in children with severe CNS impairment, with enteral nutrition delivered via nasogastric, nasoenteral, or percutaneous tubes, based on continuous glycaemic monitoring (CGM) and the measurement of glycated haemoglobin (HbA1c) levels. MATERIALS AND METHODS: This prospective, observational study included nineteen patients (median (25-75 pc) age: 12.75 (6.17-15.55) years) with permanent CNS damage (Gross Motor Function Classification System V) receiving long-term tube enteral feeding, recruited from two paediatric university nutritional treatment centres. Patients with acute conditions and diagnosed diabetes were excluded. The nutritional status and nutritional support were analysed in all the inpatients in accordance with a uniform protocol. Using the CGM system (Medtronic iPro2), glycaemic curves were analysed, and in addition, HbA1C levels were determined in fourteen patients. CGM results were analysed using GlyCulator2.0. Statistical analysis was performed using the Statistica version 11 software (StatSoft Inc. Tulsa, OK, USA). RESULTS: More than half (11/19; 58%) of the patients were undernourished (BMI < 3 pc for age and gender), with the stature age being significantly lower than calendar age (5 (4.5-9) vs. 12.75 (6.17-15.55) years; p = 0.0010). The actual caloric intake was 50 (37.7-68.8) kcal/kg (median; 25-75 pc). In patients fed using the bolus method, the number of calories consumed per day was statistically significantly higher than in children subjected to a continuous feeding supply (56.00 (41.00-75.00) vs. 33.40 (26.70-50.00) kcal/kg BW (body weight; p = 0.0159). Decreases in blood glucose levels below the alarm level (<70 mg/dL) were recorded in fifteen patients (78.9%), including two patients with episodes of clinically significant hypoglycaemia (<54 mg/dL). The minimum and maximum glycaemic values recorded in any individual CGM records were 67 mg/dL (median) (minimum: 41 mg/dL; maximum: 77 mg/dL) and 146 (minimum: 114 mg/dL; maximum: 180 g/dL), respectively, for the entire recording. The maximum percentage of glycaemic concentrations > 140 mg/dL (TAR 140) recorded overnight in children with BMI ≥ 3 amounted to 1.6% vs. 0% in undernourished patients (TAR 140: 0.0 (0.00-1.6%) vs. 0% (0.00-0.0%; p = 0.0375); the percentage of glycaemic concentrations <70 mg/dL in the entire recording was comparable (0.77% (0.13-2.2%) vs. 1.8% (0.5-14.4%) vs. p = 0.2629). There was a positive correlation between the mean daily glucose recorded using the CGM method and patients' BMI z-scores (R = 0.48, p = 0.0397). No statistically significant relationship was demonstrated between the occurrence of alarm hypoglycaemia events in the CGM records and undernutrition expressed by BMI z-scores (OR = 1.50 (95%CI: 0.16-13.75), the type of diet (for commercially manufactured OR = 0.36 (95%CI: 0.04-3.52), and the modality of diet delivery (for bolus feeding OR = 2.75 (95%CI: 0.28-26.61). CONCLUSIONS: In children with chronic OU damage, enteral feeding is associated with a risk of hypoglycaemia, but further studies involving a larger number of patients are needed, and CGM might be a useful tool to estimate the metabolic adequacy of enteral nutritional support in terms of glucose control.

Oesophageal pH-Impedance for the Diagnosis of Gastro-Oesophageal Reflux Disease: Validation of General Population Reference Values in Children with Chronic Neurological Impairments.

Diagnosis of gastro-oesophageal reflux disease (GORD) in children with chronic neurological impairment (NI) remains a clinical challenge. The study aimed to validate the relevance of the reference values used to assess gastro-oesophageal reflux (GOR) in children with NI and to determine the optimal cut-off level of the pH-impedance parameter with the best predictive value for outcomes associated with endoscopic assessments of the oesophagus. Sixty-seven children (32 male, 35 female; age: interquartile range, 5 years 6 months-14 years 10 months; median, 11 years 3 months) with NI were prospectively recruited for the study. The exclusion criteria were previous fundoplication and lack of consent for the study. All patients underwent evaluations for GOR disease, including pH-impedance and gastroscopy. Based on endoscopy, oesophagitis was diagnosed in 22/67 children (32.8%); 9/67 (13.4%) were classified as having Hetzel-Dent grade III or IV. GOR was present in 18/67 children (26.9%), as determined by pH-impedance. Patients with endoscopic lesions had a significantly higher number of total reflux (p = 0.0404) and acidic episodes (p = 0.0219). The total number of reflux episodes, with a cut-off level of 44 episodes, was the pH-impedance parameter most strongly predictive of the presence of lesions in gastroscopy (specificity: 50%, sensitivity: 73%). These findings suggest that endoscopic lesions may be present in children with chronic NI with a low number of GOR episodes, as recorded by pH-impedance. The use of standardised reference norms determined for the general population may underestimate GOR episodes in this group of patients.

Analysis of frequency and risk factors for complications of enteral nutrition in children in Poland after percutaneous endoscopic gastrostomy placement.

OBJECTIVES: The aim of the study was to assess the complication rate and identify whether age, nutritional status, and history of respiratory aspiration prior to percutaneous endoscopic gastrostomy (PEG) are risk factors for post-PEG placement complications in Polish children. In addition, the safety of two enteral feeding methods (3 h vs. 8 h) after PEG insertion in children was compared. METHODS: Children with clinical indications for PEG placement were recruited from six medical centers in Poland to participate in the study. The patients were centrally randomized to receive the first bolus feed via a feeding tube at 3 h (group 1) or 8 h (group 2) after PEG placement. The preprocedural preparation, postoperative care, and resumption of feeding were performed on all of patients in accordance with the study protocol. Patients were followed for 12 mo. RESULTS: Of the 97 randomized patients, 49 were assigned to group 1 and 48 to group 2. Full feed after PEG placement was achieved within 24 to 48 h in most cases (74% vs. 82%). There were no differences between the groups regarding the number of early mild (31.3% vs. 31.3%) and serious (2.1% vs 8.3%) complications or the duration of hospitalization after PEG placement (P > 0.05). The most common serious complication after PEG placement was accidental displacement of PEG. Most reported late complications were mild. The results of the regression analysis indicate no statistically significant effect of age, body mass index standard deviation score, white blood cell count, serum albumin level, and respiratory aspiration in the medical history on the occurrence of mild and severe complications. CONCLUSIONS: The early initiation of post-PEG feeding was not associated with an increase in the number of complications. Most complications after the PEG procedure were mild. Age, serum albumin level, white blood cells, body mass index standard deviation score, and a history of aspiration to the respiratory tract were not confirmed as a risk factor for post-PEG complications in children.

Home Artificial Nutrition in Polish Children: An Analysis of 9-Year National Healthcare Provider Data.

BACKGROUND: Home artificial nutrition (HAN) is a developing method of treatment that reduces the need for hospitalizations. The epidemiology of pediatric HAN in Poland has not yet been covered in detail. This study is a longitudinal nationwide analysis of incidence, prevalence, and patients' profile for HAN in Polish children. METHODS: Assessment of National Health Fund (NFZ) data covering all pediatric patients treated with HAN in Poland between 2010 and 2018. RESULTS: HAN was received by 4426 children, 65 patients were on home enteral nutrition (HEN) or home parenteral nutrition (HPN) at different times (HEN n = 3865, HPN n = 626). HAN was most frequently started before the child was 3 years old and long-term HAN programs (5-9 years) were reported. The most common principal diagnosis in HEN was food-related symptoms and signs. In HPN, it was postoperative gastrointestinal disorders. A regionally differentiated prevalence of HAN patients and centers was demonstrated. Mortality among patients was 24.9% for HEN, and 9.6% for HPN, and the main in-hospital cause of death was cardiac arrest. CONCLUSIONS: HAN's use is increasing and evolving in Poland. Uneven distribution of patients and centers results in difficult access to the nutritional procedure which, together with the increasing number of patients, highlights the need for data analysis and development of nutrition centers.

FPIES induced by locust bean gum in an infant

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Esophageal Impedance-pH Monitoring and Pharyngeal pH Monitoring in the Diagnosis of Extraesophageal Reflux in Children.

Various clinical symptoms are attributed to extraesophageal reflux disease (EERD). Multichannel intraluminal impedance-pH monitoring (MII-pH) is considered to correlate symptoms with acid and nonacid gastroesophageal reflux (GER) events. Pharyngeal pH monitoring (Dx-pH) is considered to correlate the decrease in the pH level in the oropharynx with reported symptoms and to diagnose supraesophageal reflux. We aimed to assess the correlation between acid reflux episodes recorded by Dx-pH and GER detected via MII-pH in children with suspected EERD. The study enrolled 23 consecutive children (15 boys and 8 girls; median age 8.25 [range 3-16.5] years) with suspected EERD. MII-pH and Dx-pH were conducted concurrently in all patients. A total of 1228 reflux episodes were recorded by MII-pH. With the antimonic sensor placed inside the impedance probe, 1272 pH-only reflux episodes were recorded. Of these, 977 (76.81%) were associated with a retrograde bolus transit. Regarding GER, 630 full-column episodes extended to the most proximal pair of impedance sensors; 500 (83.33%) demonstrated an acidic character. The following acid reflux numbers were determined by the Dx-pH system: for pH < 4, n = 126; pH < 4.5, n = 136; pH < 5, n = 167; and pH < 5.5, n = 304, and for a decrease in pH > 10% relative to the baseline, n = 324. There was no significant correlation between the number of pharyngeal reflux episodes detected by Dx-pH and that of GERs identified by MII-pH. The proportion of oropharyngeal pH events that were temporally related to a GER episode increased with the extended pH criteria. The highest proportion was observed for a pH decrease of ≥10% from the baseline and did not exceed 5.2%. The application of the extended pH criteria in the Dx-pH system resulted in an increase in the number of diagnosed laryngopharyngeal refluxes; most were not temporally associated with GER episodes confirmed by MII-pH. Thus, the efficacy of the exclusive application of Dx-pH for supraesophageal gastric reflux diagnosis is uncertain.

Tolerability and safety of early enteral nutrition in children after percutaneous endoscopic gastrostomy placement: A multicentre randomised controlled trial.

BACKGROUND & AIMS: We assessed the tolerability and safety of implementing early enteral nutrition in children at 3 h after percutaneous endoscopic gastrostomy (PEG) placement to establish an optimum feeding mode in paediatric patients that reduced the fasting period, the inadequate nutritional support interval, and the hospitalisation time. METHODS: Children with clinical indications for PEG placement were recruited from six medical centres in Poland to participate in the study. The patients were centrally randomised to receive the first bolus feed, which comprised a polymeric diet (1 kcal/mL), via a feeding tube at 3 h (group 1) or 8 h (group 2) after PEG placement. The pre-procedural preparation, the post-operative care, and the resumption of feeding were performed on all of the patients in accordance with the study's protocol. The primary endpoint was the number of patients who consumed a full feed, which contained their total fluid and caloric requirements, within 48 h of the first bolus feed. The secondary endpoints were the number of complications and the duration of hospitalisation after PEG placement. RESULTS: Of the 97 randomised patients, 49 were assigned to group 1 and 48 were assigned to group 2. There were no differences between the groups regarding feeding tolerability (81.6% vs. 91.6%), the number of complications (25.5% vs. 37.5%), or the duration of hospitalisation after PEG placement (p > 0.05). Full feed post PEG placement was achieved within 24-48 h in most cases (74% vs. 82%). Most of the complications were mild. Two patients in group 2 due to dislocation of the PEG were qualified for laparotomy (at 6 days post-PEG placement in one case and at 14 days post-PEG placement in the other case). One patient in group 2 died at 7 days post-PEG placement; the death was unrelated to the investigation. CONCLUSIONS: Introducing feeding at 3 h post-PEG placement in children appears to be well tolerated. The early initiation of post-PEG feeding was not associated with an increase in the number of complications and it had no impact on the duration of hospitalisation. CLINICAL TRIAL REGISTRY: www.clinicaltrials.gov (NCT02777541; registration date: 18/05/2016).

The influence of dietary immunomodulatory factors on development of food allergy in children.

In the last few years many studies have been conducted on the role of dietary and environmental factors in the prevention of allergic diseases among children. Many studies have shown that the diet of pregnant women and children in their early postnatal life, rich in antioxidants, vitamin D, and fatty acids is beneficial as it reduces the risk of allergy in their future life. Moreover, there are many reports about the main role of gut microbiota and probiotics in the allergy prevention, what can indicate new ways of procedures in allergic diseases.

Induction Therapy With Biosimilar Infliximab in Children With Crohn Disease.

INTRODUCTION: In most European countries, an infliximab biosimilar (CT-P13) is currently in common use. In vitro and in vivo studies have proved a high similarity between CT-P13 and the reference infliximab. CT-P13 was licensed for use in patients with Crohn disease (CD) based on the extrapolation of data from preclinical studies and clinical trials in rheumatology indications. The aim of this study was to assess the similarity between CT-P13 and the originator infliximab in induction therapy in CD paediatric patients. METHODS: Thirty-six CD paediatric patients from 3 Polish academic centres who started biological therapy with CT-P13 were enrolled in this prospective, observational study. Patients received 3 induction doses (5 mg/kg) of CT-P13 at weeks 0, 2, 6. Assessment was performed before the first infusion and at week 14. RESULTS: Overall 34/36 (94.4%) patients completed induction therapy with CT-P13. A clinical response or remission after 3 initial doses was achieved in 31/36 (86%) and 24/36 (67%) of patients, respectively. Clinically and statistically significant decreases in Paediatric Crohn's Disease Activity Index, C-reactive protein, and erythrocyte sedimentation rate were observed in the responders group. An allergic reaction during infusion, which led to treatment discontinuation, was observed in one case. CONCLUSIONS: Induction therapy with CT-P13 in children with CD is effective. The profile appears similar to that reported for the reference infliximab. No unexpected adverse events occurred.

Immunogenicity of Pertussis Booster Vaccination in Children and Adolescents with Inflammatory Bowel Disease: A Controlled Study.

BACKGROUND: There are limited data on antibody response to vaccination in patients with inflammatory bowel disease (IBD). In this study, we aimed to assess the immunogenicity of a booster dose of pertussis vaccine in pediatric patients with IBD and to compare their response with healthy controls. METHODS: We performed a multicenter, prospective, and controlled trial. Eligible for inclusion were children and adolescents (11-18 year olds), with no history of pertussis booster immunization after the age of 6 years or history of pertussis. Study population was divided into 4 groups: patients with IBD receiving no immunosuppressive therapy (group 1), those on thiopurines only (group 2), those on thiopurines and TNF-α agents (group 3), and healthy controls (group 4). Patients and controls received 1 dose of pertussis vaccine intramuscularly and were asked to record adverse effects for 3 days after vaccination. The primary outcome measure was adequate vaccine response, defined as the concentration of anti-Bordetella pertussis antibodies >11 µg/mL, measured between 4 and 8 weeks after the vaccination. RESULTS: In total, 138 subjects (111 patients and 27 controls) were enrolled in the study. Rates of adequate vaccine response did not differ among the 4 study groups (P = 0.11). Moreover, those patients with IBD who were on immunosuppressive therapy did not differ from those who were not (90.6% versus 88.2%, P = 0.37). No serious adverse effects in relation to the administration of vaccine were noted. CONCLUSIONS: Booster dose of pertussis vaccine was immunogenic and safe in pediatric patients with IBD.

Endoscopic therapy of oesophageal strictures in children - a multicentre study.

INTRODUCTION: Oesophageal strictures are rare in children but may require endoscopic dilation. AIM: To gather information on centres performing endoscopic oesophageal dilation in Poland. MATERIAL AND METHODS: The data were obtained from questionnaires concerning the relevant data mailed to 22 paediatric endoscopy centres. Completed questionnaires were received from 11 centres. RESULTS: In 2010 the 11 Polish paediatric endoscopy centres performed a total of 10,650 endoscopic procedures. This included 347 oesophageal dilations in 106 paediatric patients aged from 1 month to 18 years. The numbers of patients treated at individual centres ranged from 2 to 40. The indications for oesophageal dilation were as follows: postoperative strictures in 68 children, oesophageal burns in 17 children, postinflammatory strictures in 14 children, achalasia in 4 children, and strictures caused by a foreign body in 3 children. Rigid guidewire dilators were used in the majority of procedures (271), rigid dilators without a guidewire in 32 procedures, and balloon dilators in 45 procedures. A total of 203 procedures were conducted under fluoroscopic guidance, and 144 without the use of fluoroscopy. The number of dilating sessions performed in individual children varied from 1 to 6 and more. CONCLUSIONS: Oesophageal dilation constituted a minor proportion of all paediatric endoscopic procedures. The majority of children requiring dilation were patients up to 3 years of age with postoperative oesophageal strictures. In the majority of the centres rigid guidewire dilators were used, and in one third of the procedures these dilators were introduced without fluoroscopic guidance.

The protocol for a randomised-controlled trial of the evaluation of the tolerance and safety of early enteral nutrition in children after percutaneous endoscopic gastrostomy placement. (protocol version 09.01.2015).

BACKGROUND: The appropriate time to initiate enteral nutrition after the placement of a percutaneous endoscopic gastrostomy (PEG) tube has been an area of limited research. There are no sufficient randomised prospective controlled trials in the paediatric population comparing the safety and tolerance of early feeding (3 h) after PEG placement. In order to reduce the period of fasting, inadequate nutritional support, and hospitalisation time, we decided to devise this study. METHODS/DESIGN: This study is a multicentre, randomised, open-label trial designed to evaluate the tolerance and safety of early enteral nutrition after PEG placement in children. Patients are randomised to receive the first feeding bolus with a polymeric diet (1 kcal/ml) via a feeding tube 3 h after the PEG placement (group I - early enteral feeding) or 8 h after the procedure (group II - late enteral feeding). The key objective of the study is to compare the tolerance and safety of the early- and late-feeding modes after PEG placement in children. The primary endpoint is the number of patients who will achieve full feed (total fluid and caloric requirements) within 48 h of the first feeding bolus. The secondary endpoints are: the number of early and late complications, the duration of hospitalisation after PEG placement, gastric residuals (ml) total in the period up to 48 h since the first feeding bolus. DISCUSSION: To our knowledge this is the first study in paediatric patients to evaluate the tolerance and safety of early enteral nutrition after PEG placement. The goal is to establish an optimum standard procedure in the group of paediatric patients qualified for the PEG insertion procedure in Poland. TRIAL REGISTRATION: ClinicalTrials.gov ID NCT02777541 , registration date 05/18/2016.

Complications of PEG are not related to age - The result of 10-year multicenter survey.

PURPOSE: The aim of this study was to analyze whether the insertion of Percutaneous Endoscopic Gastrostomy (PEG) during infancy is related to higher morbidity. Moreover, we analyzed the structure of indications to PEG placement in various age groups of pediatric patients. MATERIAL/METHODS: The study involved medical data of children after PEG insertion from six Polish endoscopic centers: infants (<12 months of age), toddlers (12-36 months), and preadolescents (>36 months). RESULTS: The overall prevalence of early complications associated with PEG insertion was 5.14%; while they were noted in infants and preadolescents, none were recorded in toddlers. The analyzed age groups did not differ significantly in terms of the prevalence of late complications. Cerebral palsy (34.86%) and other chronic neurological conditions (34.29%) were the most frequent indications to PEG insertion in the whole group. Patients with congenital heart defects and multiple defect syndrome were inserted PEG at the youngest age; in contrast, the age at insertion was the highest in cystic fibrosis patients. CONCLUSIONS: The early qualification to nutritional intervention via endoscopically formed gastrostomy can have important clinical implications with regards to improved therapeutic outcomes and reduced morbidity rates.

Nutritional therapy in paediatric intensive care units: a consensus statement of the Section of Paediatric Anaesthesia and Intensive Therapy the Polish Society of Anaesthesiology and Intensive Therapy, Polish Society of Neonatology and Polish Society for.

Providing nutritional therapy via the gastrointestinal tract in patients in paediatric intensive care units (PICUs) is an effective method for delivering energy and other nutrients. In the event of contraindications to using this method, it is necessary to commence parenteral nutrition. In the present study, methods for nutritional treatments in critically ill children are presented, depending on the clinical situation.

Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine administered to older infants and children naïve to pneumococcal vaccination.

BACKGROUND: Streptococcus pneumoniae infections are a major cause of morbidity and mortality in children <5 years old worldwide. To increase serotype coverage globally, a 13-valent pneumococcal conjugate vaccine (PCV13) has been developed and approved in many countries worldwide. OBJECTIVE: Assess the safety and immunogenicity of PCV13 in healthy older infants and children naïve to previous pneumococcal vaccination. METHODS: This was a phase 3, open-label, multicenter study conducted in Polish children (N=354) who were vaccinated according to 3 age-appropriate catch-up schedules: Group 1 (aged 7 to <12 months) received two PCV13 doses with a booster at 12-16 months of age; Group 2 (aged 12 to <24 months) received two vaccine doses only; and Group 3 (aged 24 to <72 months) received a single dose of PCV13. Statistical analyses were descriptive. The proportion of immunological "responders" achieving serotype-specific antipneumococcal polysaccharide concentrations ≥0.35µg/mL, 1-month after the last dose of vaccine, was determined for each vaccine serotype. In addition, antipolysaccharide immunoglobulin (Ig) G geometric mean concentrations (GMCs) were calculated. Safety assessments included systemic and local reactions, and adverse events. RESULTS: The proportion of immunological responders was ≥88% across groups for all serotypes. Antipolysaccharide IgG GMCs were generally similar across groups. Each schedule elicited immune response levels against all 13 serotypes comparable to or greater than levels previously reported in infants after a 3-dose series. The 3 catch-up schedules had similar tolerability and safety profiles; a trend was present towards greater local tenderness with increasing age and subsequent dose administration. CONCLUSIONS: Immunological responses and safety results support the use of PCV13 for catch-up schedules in older infants and children naïve to pneumococcal vaccination.

Monotherapy with infliximab versus combination therapy in the maintenance of clinical remission in children with moderate to severe Crohn disease.

OBJECTIVES: The aim of the present study was to compare the efficacy and safety of 2 protocols of maintenance therapy with infliximab (IFX) and an immunomodulatory agent in pediatric patients with Crohn disease (CD): withdrawal of immunomodulators versus continuation of immunosuppressants. METHODS: The present multicenter randomized open-label trial included 99 patients with CD (ages 14.5 ±â€Š2.6 years) who were administered IFX (5 mg/kg body weight) along with an immunomodulatory agent (azathioprine 1.5-3 mg/kg body weight per day, methotrexate 10-25 mg/week). After 10 weeks of the induction therapy, 84 responders were centrally randomized into 1 of the following groups: group I (n = 45) in which IFX and an immunomodulatory agent were continued up to week 54 and group II (n = 39) in which the immunomodulatory agent was discontinued after 26 weeks. RESULTS: The induction therapy was reflected by a significant decrease in Pediatric Crohn's Disease Activity Index (PCDAI) and Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) values. After the maintenance phase, the analyzed groups did not differ significantly in terms of the clinical response loss rates and final PCDAI and SES-CD scores. Furthermore, no significant intragroup differences were documented between mean PCDAI scores determined at the end of induction and maintenance phases. Intensification/modification of the treatment was required in 13 of 45 (29%) and 11 of 39 (28%) patients of groups I and II, respectively. A total of 9 serious adverse events were documented; none of the patients died during the trial. CONCLUSIONS: Twenty-six weeks likely represent the safe duration of combined IFX/immunomodulatory therapy in our sample of pediatric patients with CD.

Home enteral nutrition in children--2010 nationwide survey of the Polish Society for Clinical Nutrition of Children.

Published epidemiologic data on the administration rates of enteral/parenteral home nutrition is very limited. The aim of this first nationwide study was to assess the availability of pediatric home enteral nutrition (HEN) services in Poland. The questionnaire was sent to all regional centers providing pediatric HEN services in Poland (n = 14). The analysis included the number of pediatric patients who received HEN in 2010, their demographic characteristics and geographical distribution. Furthermore, the distributions of indications and methods of enteral nutrition administration were analyzed, along with the reasons of withdrawal from the HEN program. The number and fraction of children receiving HEN increased in 2010, from 433 (11.34 per 1 million inhabitants) on January 1st to 525 (13.75) on December 31st. Marked differences were observed in geographical distribution of this parameter, from zero to up to 30 pediatric patients per 1 million inhabitants. Median age of patients was 6 years (range: 9 months-18 years). In most cases, HEN was prescribed due to neurological disorders (n = 337, 64.2%), and administered by means of gastrostomy (n = 450, 85.71%). This study revealed the dynamic development of pediatric HEN services in Poland but also documented their potential regional shortages.

Influence of percutaneous endoscopic gastrostomy on gastro-oesophageal reflux evaluated by multiple intraluminal impedance in children with neurological impairment.

AIM: The aim of the study was to estimate the influence of percutaneous endoscopic gastrostomy (PEG) placement on gastro-oesophageal reflux (GOR) by using multiple intraluminal impedance (MII/pH) measurements in children with neurological impairments. METHOD: Fifteen children with neurological impairments (cerebral palsy, n=10; cerebroidolipofuscinosis, n=2; Aicardi syndrome, n=1; and secondary encephalopathy, n=2) were investigated (interquartile range [IQR] 6y 4mo-14y 8mo; median age 10y 2mo; eight male, seven female). Individuals with nutritional disorders that could not be corrected by physiological means or with swallowing disorders that either caused chronic respiratory symptoms or prevented food intake were included in the study. The exclusion criteria included previous major abdominal surgery and a lack of consent for PEG. Participants underwent MII/pH for a 24-hour period and had an oesophagogastroduodenoscopy before PEG placement, which was repeated 6 to 8 months later. RESULTS: At baseline, GOR was detected in 6 of the 15 participants, and the second MII/pH session revealed GOR in 2 of the 15 children. Differences between quantitative GOR indices obtained before and after PEG were not statistically significant, except for the proportion of the acidic/weakly acidic reflux events - among all participants in the first examination, 159 reflux episodes were acidic and 244 were weakly acidic, while in the follow-up recordings the proportion was inverted (244 acidic, 136 weakly acidic; χ(2) =47.0; p<0.001). Baseline endoscopy did not reveal any macroscopic changes in any of the examined individuals, but the follow-up examination revealed oesophagitis in two participants. The median body weight gain after 6 months as 22.0% (IQR 14.4-29.2%). All participants tolerated PEG feeding well, regardless of MII/pH results. INTERPRETATION: Identification of GOR based on MII/pH in children with neurological impairments does not exclude a good clinical response to PEG feeding.