Mobile Health technology in pediatric esophagogastroduodenoscopy quality indicators assessment: results from a national program of the Italian Society of Pediatric Gastroenterology, Hepatology and Nutrition.

BACKGROUND AND AIMS: Upper endoscopy procedures (UEP, esophagogastroduodenoscopy [EGDS] and retrograde endoscopic retrograde cholangiography [ERCP]) are an established standard of care in pediatric gastroenterology. The Pediatric endoscopy quality improvement network (PEnQuIN) recently published its pediatric-specific endoscopy quality guidelines. This study, initiated by the Italian Society of Pediatric Gastroenterology, Hepatology and Nutrition (SIGENP), aims to evaluate the adherence of Italian Pediatric Endoscopy Centers to these established quality standards. METHODS: Conducted between April 2019 and March 2021, this nationwide study utilized a smartphone app-based approach. Data encompassing pediatric endoscopy facilities, patient profiles, endoscopy indications, 17 procedure-related PEnQuIN indicators, and a GHAA-9m patient satisfaction questionnaire were systematically collected. RESULTS: A comprehensive analysis of 3582 procedures from 24 PECs revealed that 2654 (76%) were UEP. The majority of centers (75%) involved more than one operator, with 9 PEC incorporating adult endoscopists, responsible for 5% of UEPs. Overall, adherence to quality standards was good; however, areas of improvement include sub-optimal reporting of sedation details, adherence to disease-specific guidelines, and patient satisfaction questionnaire completeness (56%). The complication rate aligned with literature standards (1%), and patient satisfaction was generally high. A noteworthy observation was a 30% decrease monthly reporting rate and a shift in disease-specific patterns following the COVID-19 outbreak. CONCLUSIONS: Pediatric UEP practices in Italy adhere well to established quality standards. Emphasizing the adoption of disease-specific guidelines is crucial for optimizing resources, enhancing diagnostic accuracy, and minimizing unnecessary procedures. Prioritizing patient satisfaction is important for immediate enhancements in practice as well as for future research endeavors.

Diagnosis and management of anemia in pediatric inflammatory bowel diseases: Clinical practice guidelines on behalf of the SIGENP IBD Working group.

Anemia is one of the most frequent extra-intestinal manifestations of inflammatory bowel disease. Insidious onset, variability of symptoms and lack of standardized screening practices may increase the risk of underestimating its burden in children with IBD. Despite its relevance and peculiarity in everyday clinical practice, this topic is only dealt with in a few documents specifically for the pediatric field. The aim of the current guidelines is therefore to provide pediatric gastroenterologists with a practical update to support the clinical and therapeutic management of children with IBD and anemia. A panel of 19 pediatric gastroenterologists and 1 pediatric hematologist with experience in the field of pediatric IBD was agreed by IBD Working group of the Italian Society of Gastroenterology, Hepatology and Nutrition (SIGENP) to produce the present article outlining practical clinical approaches to the pediatric patient with IBD and anemia. The levels of evidence and recommendations have been defined for each part of the statement according to the GRADE system.

Induction of Remission With Exclusive Enteral Nutrition in Children With Crohn's Disease: Determinants of Higher Adherence and Response.

BACKGROUND: Exclusive enteral nutrition (EEN) is the first choice to induce remission and promote mucosal healing in pediatric Crohn's disease (CD). However, full adherence to EEN treatment may be problematic for children with CD. METHODS: The goal of the current multicenter retrospective study was to define predictive factors of nonadherence to treatment and nonremission at the end of induction treatment. Those data together were analyzed with the ultimate goal of trying to define an individualized induction treatment for children with CD. RESULTS: Three hundred seventy-six children with CD from 14 IBD pediatric referral centers were enrolled in the study. The rate of EEN adherence was 89%. Colonic involvement and fecal calprotectin >600 µg/g at diagnosis were found to be associated with a reduced EEN adherence. Exclusive enteral nutrition administered for 8 weeks was effective for inducing clinical remission in 67% of the total cohort. Factors determining lower remission rates were age >15 years and Pediatric Crohn's Disease Activity Index >50. CONCLUSION: Although EEN is extremely effective in promoting disease remission, several patients' related factors may adversely impact EEN adherence and response. Personalized treatments should be proposed that weigh benefits and risks based on the patient's disease location, phenotype, and disease activity and aim to promote a rapid control of inflammation to reduce long-term bowel damage.

Cyclic vomiting syndrome in children: a nationwide survey of current practice on behalf of the Italian Society of Pediatric Gastroenterology, Hepatology and Nutrition (SIGENP) and Italian Society of Pediatric Neurology (SINP).

BACKGROUND: Cyclic Vomiting Syndrome (CVS) is a rare functional gastrointestinal disorder, which has a considerable burden on quality of life of both children and their family. Aim of the study was to evaluate the diagnostic modalities and therapeutic approach to CVS among Italian tertiary care centers and the differences according to subspecialties, as well as to explore whether potential predictive factors associated with either a poor outcome or a response to a specific treatment. METHODS: Cross-sectional multicenter web-based survey involving members of the Italian Society of Pediatric Gastroenterology, Hepatology and Nutrition (SIGENP) and Italian Society of Pediatric Neurology (SINP). RESULTS: A total of 67 responses were received and analyzed. Most of the respondent units cared for less than 20 patients. More than half of the patients were referred after 3 to 5 episodes, and a quarter after 5 attacks. We report different diagnostic approaches among Italian clinicians, which was particularly evident when comparing gastroenterologists and neurologists. Moreover, our survey demonstrated a predilection of certain drugs during emetic phase according to specific clinic, which reflects the cultural background of physicians. CONCLUSION: In conclusion, our survey highlights poor consensus amongst clinicians in our country in the diagnosis and the management of children with CVS, raising the need for a national consensus guideline in order to standardize the practice.

Real-Life Use of Biosimilars in Pediatric Inflammatory Bowel Disease: A Nation-Wide Web Survey on Behalf of the SIGENP IBD Working Group.

OBJECTIVE: The aim was to assess the awareness and real-life use of biosimilars in inflammatory bowel disease (IBD) among the members of the Italian Society of Pediatric Gastroenterology, Hepatology and Nutrition (SIGENP). METHODS: An anonymous web survey involving all SIGENP IBD units which can prescribe biosimilars was conducted between July 1st and December 1st, 2020. The questionnaire included 18 questions addressing the most relevant aspects of biosimilars in pediatric IBD, i.e., advantages, disadvantages, costs, traceability, general knowledge, and real-life use. A descriptive analysis of responses was performed. RESULTS: Responses came from 26 pediatric IBD units in Italy, with representation of the North, the Center, and the South of Italy. The majority of participants (n = 20) had spent > 10 years caring for pediatric IBD patients, and worked in a center which had between 100 and 500 registered pediatric IBD patients (n = 14). Most participants (n = 18) reported they were aware that biosimilars have similar efficacy and safety to those of the originator, and all regarded cost-sparing as the main advantage of biosimilars. Most respondents (n = 20) reported they switch from originator to biosimilar in their everyday clinical practice, mostly during the maintenance phase. Most respondents (n = 20) registered no acute adverse events. Nearly all participants felt totally or very confident in using biosimilars. CONCLUSIONS: A few years after the introduction of the first biosimilar into the market, real-life data coming from the major IBD units in Italy confirm a favorable and confident position on the use of biosimilars in pediatric IBD.

Phenotype and Natural History of Children With Coexistent Inflammatory Bowel Disease and Celiac Disease.

BACKGROUND: Adult patients with both inflammatory bowel disease (IBD) and celiac disease (CeD) have peculiar phenotypic features. This study aimed at describing the characteristics and natural history of children with both IBD and CeD. METHODS: This was a case-control study based on a national registry. Cases included children diagnosed with both IBD and CeD. Two matched IBD controls without CeD, and 2 matched CeD controls were selected for each case. Inflammatory bowel disease phenotype and natural history, comprising growth and pubertal development, were compared between groups. RESULTS: Forty-nine (1.75%) patients with IBD and CeD were identified out of 2800 patients with IBD. Compared with patients with IBD alone, patients with IBD and CeD presented more frequently with autoimmune diseases (odds ratio, 2.81; 95% CI, 0.97-8.37; P = 0.04). Ileocolonic localization (46.1% vs 73.1%), treatment with azathioprine (46.2% vs 71.2%), and anti-TNF biologics (46.2% vs 69.2%) were less common in patients with Crohn's disease and CeD than in patients with Crohn's disease alone. Patients with ulcerative colitis and CeD had an increased risk of colectomy despite similar medical treatments compared with patients with ulcerative colitis alone (13.0% vs 0%). Pubertal delay was more common in patients with IBD and CeD compared with patients with IBD alone (14.9% vs 3.2%; odds artio, 5.24; 95% CI, 1.13-33.0; P = 0.02) and CeD alone (14.9% vs 1.1%; P = 0.002). CONCLUSIONS: Children with IBD and CeD may have peculiar features with a higher risk for autoimmune diseases, colectomy, and pubertal delay compared with IBD alone.

Impact of COVID-19 pandemic on the management of paediatric inflammatory bowel disease: An Italian multicentre study on behalf of the SIGENP IBD Group.

BACKGROUND: IBD management has been significantly affected during the COVID-19 lockdown with potential clinical issues. AIMS: The aim of this study was to analyse the impact of COVID-19 pandemic on the Italian paediatric IBD cohort. METHODS: This was a multicentre, retrospective, cohort investigation including 21 different Italian IBD referral centres. An electronic data collection was performed among the participating centres including: clinical characteristics of IBD patients, number of COVID-19 cases and clinical outcomes, disease management during the lockdown and the previous 9 weeks. RESULTS: 2291 children affected by IBD were enrolled. We experienced a significant reduction of the hospital admissions [604/2291 (26.3%) vs 1281/2291 (55.9%); p < 0.001]. More specifically, we observed a reduction of hospitalizations for new diagnosis (from n = 44 to n = 27) and endoscopic re-evaluations (from n = 46 to n = 8). Hospitalization for relapses and surgical procedures remained substantially unchanged. Biologic infusions did not significantly vary [393/2291 (17.1%) vs 368/2291 (16%); p = 0.3]. Telemedicine services for children with IBD were activated in 52.3% of the centres. In 42/2291(1.8%) children immunosuppressive therapies were adapted due to the concurrent COVID-19 pandemic. CONCLUSION: Due to the several limitations of the lockdown, cares for children with IBD have been kept to minimal standards, giving priorities to the urgencies and to biologics' infusions and implementing telemedicine services.

Gut-Brain Axis Exploration: Stabilometric Platform Performances in Children Affected by Functional Gastrointestinal Disorders.

OBJECTIVE: The pathophysiology of functional gastrointestinal disorders (FGIDs) is associated with dysfunction at various levels of the gut-brain axis. Hypervigilance can result in an increased tendency to report pain. In the present study, we aimed to explore whether hypervigilance can influence attentional processing in postural control in children with FGIDs. PATIENTS AND METHODS: Fifty-nine participants classified into healthy subjects, those with FGIDs, and those with organic diseases (Org) based on Rome IV criteria were enrolled. Postural control under 6 sensory conditions was evaluated using a stabilometric platform. The mean velocity of the center of pressure (CoP) displacement in the anteroposterior direction and the mediolateral direction, the length of the CoP trajectory, and the sway area were also measured. RESULTS: With visual and somatosensorial normal inputs, participants with FGIDs showed a higher number of anteroposterior (FGIDs: 4[interquartile range [IQR] 3-7], control [Cntl] 3 [IQR 3-4], P  < 0.05) latero-lateral oscillations (FGIDs: 3 [IQR 3-6], Cntl 3 [IQR 2-3], P  < 0.05) and a higher perimeter value (FGIDs: 148 [IQR 121-240], Cntl 124 [IQR 111-140], P  = 0.056) compared to healthy subjects. With normal visual but altered somatosensorial input, subjects with FGIDs showed higher values of all parameters (anteroposterior: FGIDs 6[IQR 5-8], Cntl and Org 5 [IQR 4-6], P  < 0.05; latero-lateral FGIDs 6 [IQR 4-8], Cntl 4 [IQR 4-5], Org 4[IQR 3-5], P  < 0.05; perimeter FGIDs 253 [IQR 167-305], Cntl 185 [IQR 161-217], Org 176 [IQR 142-219], P  < 0.05; area FGIDs 98 [IQR 81-233], Cntl 86 [IQR 59-114], Org 56 [IQR 41-97], P < 0.05). CONCLUSIONS: The higher number of oscillations in subjects with FGIDs who had normal visual input could be expression of alteration in attention and therefore hypervigilance as hypothesized in the context of gut-brain axis alterations.

Management of paediatric IBD after the peak of COVID-19 pandemic in Italy: A position paper on behalf of the SIGENP IBD working group.

Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2, spreading in Italy during the first months of 2020, abruptly changed the way of practicing medicine in this country. As a consequence of the lockdown, the diagnostic and therapeutic management of paediatric chronic conditions, such as inflammatory bowel disease (IBD) has been affected. During the peak of COVID-19 pandemic, elective visits, endoscopies and infusions have been postponed, with potential clinical and psychological impact on disease course and a high likelihood of increasing waiting lists. While slowly moving back towards normality, clinicians need to recognize the best ways to care for patients with IBD, carefully avoiding risk factors for new potential epidemic outbreaks. In this uncertain scenario until the development and spread of COVID-19 vaccine, it is necessary to continue to operate with caution. Hereby we provide useful indications for a safer and gradual restarting of routine clinical activities after COVID-19 peak in Italy.

A well-tolerated new amino acid-based formula for cow's milk allergy.

OBJECTIVES: Infants with cow's milk allergy (CMA) are in need of a substitute formula up to 2 years. The are three requisites for a substitute of milk in CMA: tolerability, nutritional adequacy, and cost-effectiveness. We evaluate here the tolerability of a new amino acid-based infant formula for the management of CMA. METHODS: In a phase III/IV prospective, multicentre, open-label, international study, infants and children with immunoglobulin E-mediated CMA were exposed to a diagnostic double-blinded, placebo-controlled food challenge with a new amino acid formula by Blemil Plus Elemental using Neocate as the placebo. If tolerant to it, the study formula was integrated into the patients' usual daily diet for 7 days. Efficacy on day 7 was assessed in terms of symptoms associated with CMA, amount of formula consumed, nutritional and energy intake, and anthropometric data. RESULTS: Thirty children (17 M and 13 F; median age, 1.58; range, 0.08-12.83 years) completed the open challenge and were able to consume the study formula for at least 7 days. No signs or symptoms of allergic reactions were recorded among children assuming either the test or the control formula, with a lower 95% one-sided confidence interval for the proportion of subjects who did not experience allergic reactions above 90%. Sixteen patient under the age of two continued with the optional extension phase. CONCLUSIONS: The study formula meets the American Academy of Pediatric criteria for hypoallergenicity and is well tolerated in short-term use. During optional phase, growth of the patients was not hindered by the study formula.

Short stature: an ordinary sign for an unordinary diagnosis.

BACKGROUND: Short stature (SS) is a relatively early sign of poor health. Only in 5% of cases we can explain it through the presence of endocrinological pathologies. Therefore, if SS is present since the first months of life, it is necessary to investigate all systemic disorders with secondary effects on growth. CASE PRESENTATION: We report the case of a 16-months-old male infant with severe SS apparently not associated with other clinical signs or symptoms. The patient arrived to our attention after he was hospitalized for an Echovirus enteritis, associated to moderate neutropenia (800/mm3) and hypertransaminasemia (AST 116 U/L, ALT 88 U/L) at the age of 13 months. SS was detected in that occasion. Since SS persisted even after the complete resolution of enteritis symptoms, he was taken care by our unit. CONCLUSIONS: SS appeared in the first months of life and associated with moderate neutropenia and hypertransaminasemia led us to the diagnosis of Shwachmann-Diamond syndrome. We recommend paying further attention to this condition during the differential diagnosis of children with severe SS.

Lung Function in Women with Idiopathic Central Precocious Puberty: A Pilot Study
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BACKGROUND: Studies have reported that women with early menarche (≤10 years) have lower lung function. AIM: To investigate lung function in women with a history of idio pathic central precocious puberty (ICPP) treated during childhood with gonadotropin-releasing hormone agonist (GnRHa). METHODS: ICPP women (n = 23) were compared with healthy age-matched controls (n = 23). Subjects were clinically evaluated by means of a questionnaire, baseline and post-ß₂ agonist spirometry, impulse oscillometry (a measure of airway resistance), and measurement of fractional exhaled nitric oxide (FeNO). RESULTS: Patients had lower lung function values than controls: forced expiratory volume in 1 s (FEV₁) (median 97.90 vs. 109.45; p = 0.011), FEV₁ after ß₂ agonist (100.80 vs. 114.10; p = 0.013), peak expiratory flow (92.90 vs. 97.95; p = 0.031), and maximum mid-expiratory flow (MMEF) (80.80 vs. 106.30; p = 0.008). FeNO was significantly lower in the patients (p < 0.001). Significant reversibility of FEV₁ after ß₂ agonist was observed in 8.7% of the patients. FEV₁/forced vital capacity and MMEF after ß₂ agonist correlated negatively with hysterometry at diagnosis (p = 0.009 and p = 0.03, respectively). There was a negative correlation between age at diagnosis and airway resistance. CONCLUSIONS: Women with ICPP seem to have lower lung function despite treatment with GnRHa. Further research on the effects of sex hormones on the airways should take into account potential interplay with factors affecting the start of puberty.
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Biochemical parameters and anthropometry predict NAFLD in obese children.

The aim of the present study was to build a predictive model of nonalcoholic fatty liver disease (NAFLD) in obese children. Fifty-six obese 10-year-old children underwent blood tests for biochemical measures and magnetic resonance imaging for NAFLD diagnosis. A model combining waist-to-height ratio, homeostasis model assessment of insulin resistance, adiponectin, and alanine aminotransferase was accurate in predicting NAFLD (AUROC = 0.94 [95% confidence interval 0.89-0.99], P < 10). When adiponectin was not included in the model, the discrimination accuracy was still good (AUROC = 0.88 [95% confidence interval 0.79-0.97], P < 10). In conclusion, a predictive equation combining routinely available variables may allow physicians to identify obese children at the highest risk of NAFLD.

The relationship between body mass index and body size dissatisfaction in young adolescents: spline function analysis.

This study assessed how body size dissatisfaction (BSD) varies in relationship to specific body mass index (BMI) values in a sample of preadolescents. A novel statistical approach based on spline function, suitable to assess in detail how two variables are related, was used. The study was conducted between December 2004 and March 2005. Students (aged 11 to 14 years) from seven selected secondary schools in Verona, Italy, were invited to participate. The final study group included 678 subjects. BSD was assessed using the Body Image Assessment Procedure. BMI values were expressed as z scores. It was found that, in the total sample, slightly underweight subjects (BMI z scores=-0.5) had no BSD. BSD progressively increased (current body size > ideal body size) for BMI z scores >-0.5 and became negative (ideal body size > current body size) for BMI z scores <-0.5. In boys, average weight subjects had no BSD. BSD progressively increased for BMI z scores >0 and became negative for BMI z scores <0. In girls, moderately underweight subjects (BMI z scores=-1) had no BSD. BSD progressively increased for BMI z scores >-1 and became negative for BMI z scores <-1. Although sex significantly moderated the relationship between BMI and BSD (P<0.001), socioeconomic status did not (P=0.459). Because average weight and slightly underweight young girls desired a thinner body, our study suggests that these subgroups should receive particular attention in public health programs as well as in dietetics clinical practice.

Fasting plasma glucose (FPG) and the risk of impaired glucose tolerance in obese children and adolescents.

A timely diagnosis of impaired glucose tolerance (IGT) is desirable in obesity. The oral glucose tolerance test (OGTT), the gold standard to diagnose this condition, may not be realistically performed in all patients due to discomfort, labor, and cost. The aim of this study was to assess whether one or more biochemical indexes measured in fasting conditions could be used to identify obese children at risk of IGT. A cohort of 563 white obese children and adolescents (M/F: 315/248; aged 4-17 years) was recruited and underwent anthropometric evaluation and OGTT. Anthropometric parameters, fasting plasma glucose (FPG), fasting serum insulin (FSI), and homeostasis model assessment of insulin resistance (HOMA(IR)) were tested in pursuit of a possible threshold to be used as a predictor of IGT. Thirty-seven children (6.9%) had IGT and one child (0.1%) had type 2 diabetes (T2D). FPG, FSI, and HOMA(IR) were all significantly higher in children with IGT than in children without IGT. Receiver-operating characteristic (ROC) curve analyses run for gender and puberty-adjusted FPG, FSI, and HOMA(IR) were all significant: area under the curve (95% confidence interval) equaled 0.68 (0.59-0.76), 0.66 (0.56-0.76), and 0.68 (0.59-0.78), respectively. The three parameters did not show significantly different sensitivity/specificity in the pooled population or in the gender/puberty subgroups. Thresholds varied among gender/puberty subgroups for FSI and HOMA(IR), but not for FPG, which showed a fixed threshold of 86 mg/dl. A gender/puberty independent cutoff of FPG may be considered a screening tool to narrow clinical indication to OGTT in obese white children and adolescents.

The relationship between body size and depression symptoms in adolescents.

OBJECTIVE: To evaluate the relationship between body size and depressive symptoms, as well as the moderating effects of age, sex, and socioeconomic status (SES), in a sample of young adolescents. STUDY DESIGN: The study group comprised 678 young adolescents (age 11 to 14 years). Body mass index (BMI) z scores were used to estimate body size. Depression symptoms were assessed using the Children's Depression Inventory (CDI). The spline function was used to examine the shape of the relationship between BMI z score and depressive symptoms. RESULTS: In the total sample, CDI scores were lowest for BMI z scores between -1 and -0.5. CDI scores increased progressively for BMI z scores > 0. In boys, CDI scores increased for BMI z scores > 2, whereas in girls, CDI scores increased for BMI z scores > -0.5 and < -1. Age did not have a significant moderating effect. SES had a moderating effect only in boys (P = .011). CONCLUSIONS: The relationship between body size and depressive symptoms in young adolescents is curvilinear and is moderated by sex. Heavier-than-average and underweight girls, as well as obese boys, had the highest depression scores.