Elexacaftor/tezacaftor/ivacaftor (ETI) is a cystic fibrosis (CF) transmembrane conductance regulator modulator, which has shown efficacy in people with CF (pwCF) carrying the F508del (F) variant, both in homozygosity and heterozygosity with a minimal function (MF) variant. Limited data exist on the effects of ETI in pwCF with advanced lung disease. Our aim was to investigate ETI safety and effectiveness in this patient group in a real-life setting over 2 years. A multicenter observational cohort study was designed to gather real-world information on the effect of ETI treatment on CF patients (aged >12 years, genotype: F/MF mutation) with advanced lung disease as defined by a FEV1 < 40% predicted. Retrospective demographic and clinical data were recorded for the two years preceding and the two years following ETI initiation. The following outcomes were investigated: treatment-associated adverse events (AEs), drug interruptions (temporary or permanent), variations in percent predicted FEV1 (ppFEV1), sweat chloride concentration (SwCl), antibiotic use, body mass index (BMI), and quality of life. A total of 124 (51.6% males) pwCF were treated with ETI over 2 years. The median (IQR) age and ppFEV1 were 34 (26, 43) years and 34 (29, 41) percentage points, respectively. ETI was discontinued in two pwCF due to lung transplantation, and temporarily interrupted in two because of skin rash, and in three following elevated levels of aminotransferase. Most AEs were mild and short-lasting. In 12.1% pwCF, we registered an increase greater than twice the upper limit of the normal range in alanine aminotransferase, and in 16% we registered an increase in conjugated bilirubin with no increase in aminotransferase. Both increases were recurrent in about half of the subjects. The mean differences (95% CI) for ppFEV1 and SwCl, assessed as mean values in the pre-ETI and ETI treatment periods, were +11.8 (11.1 to 12.6) and -43.7 (-47.6 to -39.9) mmol/L. A modest increase in ppFEV1 persisted during the second year of treatment. Number of oral and IV antibiotic cycles/year, as well as hospitalizations/year, decreased significantly from 3.6 to 1.2, from 2.4 to 0.6, and from 2.1 to 0.5 during ETI treatment. A total of 8 of 16 (50%) pwCF were taken off the waiting list for lung transplantation, and significant reductions in the percentages of pwCF using long-term oxygen therapy and non-invasive ventilation were observed. A poor concordance between ppFEV1 and SwCl was found. In only 3/82 (3.7%), subjects with chronic airway infection by Pseudomonas aeruginosa cultures were always negative during ETI treatment. In CF patients with advanced lung disease on ETI treatment, we observed an improvement in a number of clinically significant outcomes over a 2-year study period. However, several additional observations, such as liver dysfunction, variable degrees of lung function improvement, and limited impact on chronic airway infection, underscore the fact that the benefit-risk profile of ETI treatment in cystic fibrosis patients with advanced lung disease has not been fully elucidated and warrants prolonged-term monitoring.
Background Recurrent Upper Respiratory Tract Infections (R-URTIs) pose a significant challenge in pediatric healthcare, affecting both children and their families. This study aimed to investigate the prevalence, risk factors, and clinical implications of R-URTI in children aged 0–5 years. Methods This observational study involved a sample of 483 children aged 0–5 years, focusing on establishing a practical and dynamic definition of R-URTI. Family pediatricians prospectively collected socio-demographic information, medical history, and recorded the occurrence of URTI episodes. Children were followed from recruitment until March 2021, predating the COVID-19 outbreak. Results A substantial prevalence of R-URTIs was found, estimating it at 5–10% among this age group. To define R-URTI, a practical and dynamic criterion was proposed: children experiencing a minimum of four URTI episodes, each lasting four days or more, within a six-month period, with intervals of well-being in between. Conclusions The study highlighted that specific risk factors for R-URTI were elusive, suggesting that this condition may affect children regardless of their family or clinical history. Moreover, the study’s stratification by age group and times of observation facilitated patient-specific clinical decision-making. The proposed definition may represent a valuable tool for clinicians in diagnosing and addressing R-URTI cases.
Abstract Background Recovery from acute COVID-19 may be slow and incomplete: cases of Post-Acute Sequelae of COVID (PASC) are counted in millions, worldwide. We aimed to explore if and how the pre-existing Socio-economic-status (SES) influences such recovery. Methods We analyzed a database of 1536 consecutive patients from the first wave of COVID-19 in Italy (February-September 2020), previously admitted to our referral hospital, and followed-up in a dedicated multidisciplinary intervention. We excluded those seen earlier than 12 weeks (the conventional limit for a possible PASC syndrome), and those reporting a serious complication from the acute phase (possibly accounting for symptoms persistence). We studied whether the exposition to disadvantaged SES (estimated through the Italian Institute of Statistics’s model – ISTAT 2017) was affecting recovery outcomes, that is: symptoms (composite endpoint, i.e. at least one among: dyspnea, fatigue, myalgia, chest pain or palpitations); Health-Related-Quality-of-Life (HRQoL, as by SF-36 scale); post-traumatic-stress-disorder (as by IES-R scale); and lung structural damage (as by impaired CO diffusion, DLCO). Results Eight-hundred and twenty-five patients were included in the analysis (median age 59 years; IQR: 50–69 years, 60.2% men), of which 499 (60.5%) were previously admitted to hospital and 27 (3.3%) to Intensive-Care Unit (ICU). Those still complaining of symptoms at follow-up were 337 (40.9%; 95%CI 37.5–42.2%), and 256 had a possible Post-Traumatic Stress Disorder (PTSD) (31%, 95%CI 28.7–35.1%). DLCO was reduced in 147 (19.6%, 95%CI 17.0–22.7%). In a multivariable model, disadvantaged SES was associated with a lower HRQoL, especially for items exploring physical health (Limitations in physical activities: OR = 0.65; 95%CI = 0.47 to 0.89; p = 0.008; AUC = 0.74) and Bodily pain (OR = 0.57; 95%CI = 0.40 to 0.82; p = 0.002; AUC = 0.74). We did not observe any association between SES and the other outcomes. Conclusions Recovery after COVID-19 appears to be independently affected by a pre-existent socio-economic disadvantage, and clinical assessment should incorporate SES and HRQoL measurements, along with symptoms. The socioeconomic determinants of SARS-CoV-2 disease are not exclusive of the acute infection: this finding deserves further research and specific interventions.
BACKGROUND:Recovery from acute COVID-19 may be slow and incomplete: cases of Post-Acute Sequelae of COVID (PASC) are counted in millions, worldwide. We aimed to explore if and how the pre-existing Socio-economic-status (SES) influences such recovery. METHODS:We analyzed a database of 1536 consecutive patients from the first wave of COVID-19 in Italy (February-September 2020), previously admitted to our referral hospital, and followed-up in a dedicated multidisciplinary intervention. We excluded those seen earlier than 12 weeks (the conventional limit for a possible PASC syndrome), and those reporting a serious complication from the acute phase (possibly accounting for symptoms persistence). We studied whether the exposition to disadvantaged SES (estimated through the Italian Institute of Statistics's model - ISTAT 2017) was affecting recovery outcomes, that is: symptoms (composite endpoint, i.e. at least one among: dyspnea, fatigue, myalgia, chest pain or palpitations); Health-Related-Quality-of-Life (HRQoL, as by SF-36 scale); post-traumatic-stress-disorder (as by IES-R scale); and lung structural damage (as by impaired CO diffusion, DLCO). RESULTS:Eight-hundred and twenty-five patients were included in the analysis (median age 59 years; IQR: 50-69 years, 60.2% men), of which 499 (60.5%) were previously admitted to hospital and 27 (3.3%) to Intensive-Care Unit (ICU). Those still complaining of symptoms at follow-up were 337 (40.9%; 95%CI 37.5-42.2%), and 256 had a possible Post-Traumatic Stress Disorder (PTSD) (31%, 95%CI 28.7-35.1%). DLCO was reduced in 147 (19.6%, 95%CI 17.0-22.7%). In a multivariable model, disadvantaged SES was associated with a lower HRQoL, especially for items exploring physical health (Limitations in physical activities: OR = 0.65; 95%CI = 0.47 to 0.89; p = 0.008; AUC = 0.74) and Bodily pain (OR = 0.57; 95%CI = 0.40 to 0.82; p = 0.002; AUC = 0.74). We did not observe any association between SES and the other outcomes. CONCLUSIONS:Recovery after COVID-19 appears to be independently affected by a pre-existent socio-economic disadvantage, and clinical assessment should incorporate SES and HRQoL measurements, along with symptoms. The socioeconomic determinants of SARS-CoV-2 disease are not exclusive of the acute infection: this finding deserves further research and specific interventions.
Background: Currently, no consensus guidelines recommend routine bronchoscopy procedure in cystic fibrosis (CF), as no evidence is available concerning its use as either a diagnostic or therapeutic tool. Its efficacy is controversial, and no randomized controlled prospective trials are available to check its effectiveness. The aims of the present study were to evaluate the effectiveness of bronchoscopy as a diagnostic/therapeutic tool in CF children and adolescents; and to verify the effect of serial bronchoscopy on lung disease progression in subjects with CF not responding to a single procedure. Methods: Data of patients who received bronchoscopy at 2 Italian CF centers were collected. Bronchoalveolar lavage was performed during the procedure including airway clearance with mucolytics, inhaled antibiotics, and/or surfactant instillation. Results: A total of 16 patients in center 1 and 17 in center 2 underwent, respectively, 28 and 23 bronchoscopic procedure in the study period. Five patients in each center underwent >1 procedure. All procedures were generally well tolerated. No patient required admission to the pediatric intensive therapy unit. In 19.6% of bronchoalveolar lavages, growth of Aspergillus fumigatus was evident, although not detected by sputum analyses. After the procedure, an increase in mean percent predicted forced expiratory volume in the 1 second >10% was observed, and a significant decrease in pulmonary exacerbations yearly was evident. Conclusion: Based on the results, we suggest bronchoscopy is not to be considered an obsolete tool, and it remains useful in CF management, although in selected cases. We encourage to support longitudinal observational studies to standardize the procedure, focusing on the choice of drugs to be instilled, modalities and timing of serial bronchoscopy and subsequent follow-up in selected severe clinical conditions.
Antibiotic overuse in children is a significant public health concern, as it can lead to the emergence and spread of antibiotic-resistant bacteria. Although respiratory infections account for most antibiotic prescriptions in children, many of these infections are viral and do not require antibiotics. In this study, we aimed to investigate the use of antibiotics in children with respiratory infections in a primary care setting and to explore the possible role of fever on antibiotic prescription. We conducted a prospective observational study that evaluated preschool children aged 0–5 years who were assessed by their primary care pediatricians for respiratory infectious diseases between October 2019 and March 2021. The study involved 69 public primary care pediatricians and a total of 678 pediatric episodes for respiratory infections. Amoxicillin/clavulanate was the most frequently prescribed drug. Bronchitis accounted for most of inappropriate antibiotic prescriptions (73
Background:Sodium intake is known to contribute to the development of hypertension, thus intake reduction is a cornerstone in the prevention and management of hypertension. The increase in renal sodium excretion might represent a further potential preventive and/or therapeutic opportunity.Objective:To explore the working hypothesis that an increased fluid intake can improve renal sodium handling towards a decrease in blood pressure.Methods:The SPA Project is a multicenter, observational, cross-sectional, cohort study investigating healthy children, aged 5-8 years as to sodium and fluid intake by means of urinary sodium and creatinine from multiple samples taken in different days in order to characterize them in lower/higher sodium and lower/higher fluid intake. Both SBP and DBP (by multiple office blood pressure measurements) were used as outcome measures.Results:Three hundred and thirty-nine healthy, nonoverweight children (51.6% boys) with a median age of 5.7 years old (IQR: 5.3-6.2) participated in the study but only 223 could be analyzed. Among children with higher sodium intake, those introducing more fluids, showed a significantly lower blood pressure (both systolic and diastolic) compared with those with lower fluid intake: systolic 86.0 +/- 8.5 vs. 90.0 +/- 8.1 mmHg; P = 0.014 and diastolic: 53.8 +/- 4.9 vs. 58.6 +/- 6.6 mmHg; P < 0.0001.Conclusion:An increased fluid intake is associated with a reduced blood pressure possibly by increasing renal sodium excretion. We speculate that this simple, highly acceptable, inexpensive, and harmless measure might have a role in preventing and/or minimizing the epidemics of hypertension and of its related morbidities both in children and in adults.
Introduction: Very few studies have been published on the clinical history and contagiousness of not hospitalized Covid-19 pediatric patients. Therefore, to get deeper in this topic, between October 2020 and March 2021, we carried out an observational study in the pediatric primary care setting in Italy. Methods: The study enrolled patients with Covid-19 disease (cases); patients with suspicious symptoms but negative swab; close contacts of Covid-19 cases. The follow-up was 28 days for patients with Covid-19 disease, 14 days for the other subjects enrolled. Results: 1947 patients aged 0-13 were enrolled: 465 with Covid-19 disease; 549 with suspicious symptoms but negative swab; 933 close contacts of Covid-19 cases. 130 subjects with Covid-19 were asymptomatic at the time of diagnosis. Among the others, in children aged 0-2 the most frequent symptom was rhinitis (41%) followed by fever (38%) and cough (31%). In children aged 3-13 the most frequent symptom was headache (30%) followed by rhinitis (23%), asthenia (18%), fever (16%), cough (11%). No symptoms alone were sufficient to induce or rule out the suspicion of the Covid-19 disease diagnosis. A multiple logistic regression analysis, conducted for the purpose, allowed to build a score capable of inducing disease suspicion in patients older than 2 years of age, based on: fever, rash, rhinitis, headache and asthenia. Conclusions: This study compared subjects with SARS-CoV-2 infection with unaffected subjects with similar symptoms and confirmed that it is impossible to clinically distinguish Covid-19 from other similar respiratory diseases in pediatric age. The obtained score, potentially useful and valid during the study period, could not be applied in other epidemiological scenarios.
Introduzione: non esistono in letteratura molte pubblicazioni sulla storia clinica e la contagiosità dei casi pediatrici di Covid-19 non ospedalizzati.Per tale motivo abbiamo effettuato uno studio osservazionale prospettico nel setting della pediatria di famiglia italiana tra ottobre 2020 e marzo 2021 di cui vengono qui riportati i risultati del follow-up.Materiali e metodi: si tratta di uno studio osservazionale che ha arruolato: pazienti affetti da Covid-19; pazienti con sintomatologia sospetta ma con tampone negativo; contatti stretti familiari di casi di Covid-19.Il follow-up dei pazienti arruolati è stato di 28 giorni per i casi con diagnosi confermata, di 14 giorni per gli altri soggetti.L'analisi dei sintomi è stata effettuata separatamente secondo due classi di età, 0-2 anni e 3 anni o più.Per ognuno dei sintomi studiati si è proceduto a rilevare sia la prevalenza di soggetti con il sintomo nei diversi giorni, sia la distribuzione della durata del sintomo (in giorni) nei diversi soggetti.Tutte queste analisi sono state ripetute per due sottogruppi: i bambini esposti al fumo passivo e quelli con malattia cronica.Risultati principali: sono stati arruolati 1.947 pazienti di età inferiore a 14 anni: 465 con diagnosi di Covid-19; 549 soggetti con sintomatologia compatibile ma con tampone negativo; 933 contatti stretti di Covid-19.130 soggetti con Covid-19 erano asintomatici al momento della diagnosi.Sono state raccolte informazioni al follow-up da 343 pazienti positivi (73,7%); 414 pazienti con tampone negativo (75,4%); 595 contatti stretti (63,8%).Da un confronto tra i pazienti positivi e quelli con tampone negativo, si evidenzia come i sintomi abbiano una frequenza e una durata maggiori in questi ultimi, soprattutto nei bambini più piccoli.L'analisi dei soli pazienti positivi mette in rilievo come frequenza e durata di tutti i sintomi considerati risultano maggiori nei bambini piccoli rispetto a quelli più grandi.
Abstract Introduction The incidence of acute respiratory tract infections (ARTIs) in children is difficult to estimate because they are typically treated in outpatient settings and the majority of epidemiological data originate from hospital settings and refer to the most severe illnesses. Therefore, the incidence of ARTIs in a real-world setting remains largely unexplored. Therefore, this study aims to estimate the incidence of ARTIs, upper respiratory tract infections (URTIs), and lower respiratory tract infections (LRTIs) in children aged 0–5 years in an outpatient setting. Methods This prospective cohort study was conducted in Lombardy, Italy, from October 1st, 2019, to March 31st, 2021, before and during the COVID-19 pandemic that began in March 2020. Caucasian healthy children aged 0–5 years were recruited from 69 Family Pediatricians (FP) and followed-up in an outpatient setting. Data were collected whenever a child was referred to FP and ARTI was diagnosed (Covid-19 related ARTI were excluded). The primary outcome was an estimate of the incidence of ARTIs. The incidence of ARTIs in different age groups and the effect of the COVID-19 pandemic on the incidence of ARTIs were secondary outcomes. Results We enrolled 484 children, 249 male (51.8%), mean age of 2.39 ± 1.68 years. The mean estimated incidence of ARTIs was 12.1/100 children × 30 days (95% CIs: 9.5–12.9), with the highest value observed in infants aged 1–12 months (24.9/100 children × 30 days; 95% CIs: 17.6–28.9). The mean estimated incidence of URTIs was higher than that of LRTIs (8.3 – CIs: 7.6–8.9 vs 3.8/100 children × 30 days – CIs: 6.4–4.3, respectively). The comparison of ARTIs, which occurred in the pre-pandemic winter, to those measured during the COVID-19 pandemic, revealed an impressive 82.1% drop in the incidence rate (CIs: 77.8–85.7). Conclusions This study showed that infants aged 1–12 months are more likely to develop ARTIs than older children and that COVID-19 pandemic has dramatically altered the epidemiology of ARTIs in children aged 0–5 years.
Objectives We aimed to identify clinical, anamnestic, and sociodemographic characteristics associated with a positive swab for SARS-CoV2, and to provide a predictive score to identify at risk population in children aged 2–14 years attending school and tested for clinical symptoms of COVID-19. Design Cross sectional study. Setting Outpatient clinic of the IRCCS Burlo Garofolo, a maternal and child health tertiary care hospital and research centre in Italy. Data collection and analysis Data were collected through a predefined form, filled out by parents, and gathered information on sociodemographic characteristics, and specific symptoms, which were analysed to determine their association with a positive SARS-CoV-2 swab. The regression coefficients of the variables included in the multivariate analysis were further used in the calculation of a predictive score of the positive or negative test. Results Between September 20th and December 23rd 2020, from 1484 children included in the study, 127 (8.6%) tested positive. In the multivariate analysis, the variables retained by the model were the presence of contact with a cohabiting, non-cohabiting or unspecified symptomatic case (respectively OR 37.2, 95% CI 20.1–68.7; 5.1, 95% CI 2.7–9.6; 15.6, 95% CI 7.3–33.2); female sex (OR 1.49, 95% CI 1.0–2.3); age (6–10 years old: OR 3.2, 95% CI 1.7–6.1 p<0.001; >10 years old: OR 4.8, 95% CI 2.7–8.8 p<0.001); fever (OR 3.9, 95% CI 2.3–6.4); chills (OR 1.9, 95% CI 1.1–3.3); headache (OR 1.45, 95% CI 0.9–2.4); ageusia (OR 1.3, 95% CI 0.5–4.0); sore throat (OR 0.48, 95% CI 0.3–0.8); earache (OR 0.4, 95% CI 0.1–1.3); rhinorrhoea (OR 0.8, 95% CI 0.5–1.3); and diarrhoea (OR 0.52, 95% CI 0.2–1.1). The predictive score based on these variables generated 93% sensitivity and 99% negative predictive value. Conclusions The timely identification of SARS-CoV2 cases among children is useful to reduce the dissemination of the disease and its related burden. The predictive score may be adopted in a public health perspective to rapidly identify at risk children.
BACKGROUND:Cystic fibrosis (CF) is a multi-organ genetic disease caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene which encodes the CFTR protein. CF-associated liver disease (CFLD) is a common complication; diagnosis is based on clinical, laboratory findings and abdominal imaging. However, non-invasive diagnostic approaches are needed to early detect CFLD, its progression and severity. Recent studies demonstrate a possible role of point shear wave elastography (p-SWE) with liver stiffness measurement (LSM) as a tool for CFLD diagnosis also in children. This non-invasive technique measures liver stiffness to assess liver fibrosis and is suggested to be less operator-dependent compared to ultrasonography. Aim of our prospective observational study is to investigate the role of p-SWE with LSM for CFLD diagnosis in children and adolescents with CF and to compare this finding with aspartate aminotransferase to platelet ratio index (APRI), fibrosis index based on four factors (FIB-4) and gamma-glutamyl-transpeptidase to platelet ratio (GPR) indices. METHODS:Fifty-nine children with CF, who had routinely undergone abdominal imaging, were consecutively enrolled. Laboratory findings and clinical data were recorded, as abdominal ultrasound and shear wave elastography at baseline. The cases were divided into two groups based on collected data and classified as CFLD and CFnoLD (without liver disease) according to Debray criteria. APRI, FIB-4 and GPR fibrosis indices were also evaluated. RESULTS:Twenty-four/59 (40.7%) were defined as CFLD. LSM test is superior to the APRI (P<0.001), the FIB-4 test (P=0.001) and the GPR test for early detection of liver fibrosis. LSM had an area under receiver operating characteristic (ROC) curve =0.818 (95% CI: 0.702-0.934) compared with APRI (0.571, 95% CI: 0.421-0.722), FIB-4 (0.656, 95% CI: 0.511-0.801) and GPR (0.632, 95% CI: 0.485-0.779). At a cut-off of ≥6.2 LSM show a sensitivity of 75.0% and a specificity of 88.6%. CONCLUSIONS:LSM by transient p-SWE is a non-invasive, highly accessible, reliable, and reproducible test that can be used to assess early detection of liver fibrosis and its severity in children and adolescents with CF, limiting the use of liver biopsy. These preliminary observations point to the need of larger study population to confirm our data.
There is no univocal standardized strategy to predict outcomes and stratify risk of SARS-CoV-2 infected patients, notably in emergency departments. Our aim is to develop an accurate indicator of adverse outcomes based on a retrospective analysis of a COVID-19 database established at the Emergency Department (ED) of a North-Italian hospital during the first wave of SARS-CoV-2 infection. Laboratory, clinical, psychosocial and functional characteristics including those obtained from the Braden Scale-a standardized scale to quantify the risk of pressure sores which takes into account aspects of sensory perception, activity, mobility and nutrition-from the records of 117 consecutive patients with swab-positive COVID-19 disease admitted to the Emergency Medicine ward between March 1, 2020 and April 15, 2020 were included in the analysis. Adverse outcomes included admission to the Intensive Care Unit (ICU) and in-hospital death. Among the parameters collected, the highest cutoff sensitivity and specificity scores to best predict adverse outcomes were displayed by lactate dehydrogenase (LDH) blood value at admission > 439 U/L, Horowitz Index (P/F Ratio) < 257 and Braden score < 18. The estimation power reached 93.6%. We named the assessment BLITZ (Braden-LDH-HorowITZ). Despite the retrospective and preliminary nature of the data, a multidimensional tool to assess overall functions, not chronological age, produced the highest prediction power for poor outcomes in relation to SARS-CoV-2 infection. Further analyses are now needed to establish meaningful correlations between ventilation therapies and multidimensional frailty as assessed by ad-hoc validated and standardized tools.
In medicina da sempre si tenta di elaborare dei modelli per spiegare l’origine delle malattie e rendere conto dei diversi fattori causali. In questo articolo non ci occuperemo tanto di modelli matematici (elaborati per cercare di descrivere e “prevedere” l’evoluzione e la diffusione delle malattie attraverso l’analisi di funzioni costruite su numerose variabili e assunti), ma piuttosto di modelli “causali” con l’obiettivo di dare il giusto peso alle seguenti famiglie di determinanti: y genetica; y fattori modificanti (fattori di rischio in generale e comportamenti legati agli “stili di vita”); y ambiente, da intendersi in senso lato: non solo l’aspetto fisico/chimico (temperatura, umidità, altitudine, clima, inquinamento...), ma anche quello biologico (la presenza di virus e batteri, ma anche del microbioma); quello educativo, sociale, culturale, economico, politico, e non ultimo quello più strettamente sanitario (l’organizzazione dei servizi territoriali e ospedalieri, di prevenzione, cura, riabilitazione, palliazione; i posti letto, le attrezzature, i farmaci e i vaccini, le dotazioni strumentali, il personale, i locali idonei, il sistema informativo e altro ancora).
The measurement of sodium intake may be important for the management of hypertension. Dietary surveys and 24-h urinary collection are often unreliable and/or impractical. We hypothesized that urinary sodium excretion can be accurately estimated through multiple spot urine samples from different days. All enrolled subjects were children of the coauthors of the study. Fifty-two 24-h urinary collections (4 per subject) for measuring sodium excretion and the 297 related urinary samples (1 per voiding) were collected for calculating the urinary sodium/urinary creatinine ratio in 13 children. The mean of 4 measured sodium excretions served as the individual “gold standard”. Twenty-four urinary collections were used to generate the equation predicting the mean measured sodium excretion from the mean of 4 urinary sodium/urinary creatinine [= 0.016 × urinary sodium (mmol/L) / urinary creatinine (mmol/L) ratio + 3.3)]; the remaining 28 urinary collections and 153 urinary samples were used for the external validation. All subjects underwent an additional validation procedure involving 12 urinary samples randomly collected on different days 6 months apart. The performance of sodium excretion calculated from a total of over 22,000 possible means of 4 out of all the available urinary samples, randomly taken on different days, was analyzed as to precision (by means of the coefficient of variation) and as to accuracy (by means of the P30). The coefficients of variations of measured vs. calculated sodium excretion were 25.3% vs. 25.8%, and the P30 of calculated sodium excretion was 100%. The excellent performance of calculated sodium excretion was confirmed both by external validation and by samples collected 6 months apart with mean P30s, all between 86 and 100%. Conclusion: In the described experimental conditions, urinary sodium excretion was estimated with equal precision and more accurately (and practically) by the mean of 4 urinary sodium/urinary creatinine ratios from random samples from different days than by a single urinary collection. In real life, with several errors systematically affecting urinary collection, the superiority of calculated sodium excretion is likely to be even greater.
Complementary feeding practices are debated among pediatricians, primarily regarding whether nutritional needs or developmental readiness should be prioritized in recommendations for starting complementary feeding. The aim of the present study was to analyze the timing of the start of complementary feeding and the related motivations with an 8-item online survey administered to active members of the Italian Society of Primary Care Pediatricians. The participation rate was 43.3% (350 of 808), and 213 (60.9%) and 137 (39.1%) of the participants chose items related to developmental readiness and nutritional needs, respectively, as the criteria for starting complementary feeding. Approximately 74% of the participants reported that they recommended starting complementary feeding between 5 and 6 months of age, 17% recommended starting before 5 months, and 8% recommended starting after 6 months. Predefined schemes were proposed by 38% of the participants, and a responsive feeding modality was proposed by 13%, while the majority (49%) recommended both modalities depending on family characteristics. Regarding recommendations based on nutritional needs, 89% of pediatricians reported providing indications concerning the quantity of meat consumed during the first year of life, and 91% reported recommending introducing added salt only after 12 months of age. Compared with pediatricians who emphasized developmental readiness, those who prioritized nutritional needs suggested earlier complementary feeding start and a higher use of predefined schemes and were more likely to make recommendations regarding meat quantity and added salt (p < 0.0001). Conclusions: Pediatricians who used a developmental readiness criterion for starting complementary feeding may less frequently provide nutritional advice to parents, even if a trend to harmonize the different positions regarding complementary feeding start time is emerging.
Introduction and aim An early education to avoid an excessive protein and salt consumption is now considered crucial for obesity and hypertension prevention. Complementary feeding (CF) practices are debated among Pediatricians, first of all about which criterion should be considered between nutritional needs (NN) or developmental readiness (DR) for CF start. The aim of the present study was to analyze if timing of CF, modalities, and nutritional advices during the first year of life were related with the criterion considered for CF start among Pediatricians. Methods An online Survey was conducted in march 2018 among Family Pediatricians in Italy investigating the criterion chosen for CF start, timing, method of feeding and specific dietary practices. A Good Nutritional Practice (GNP) was acknowledged to those Pediatricians who declared to give advices for meat quantity and salt consumption during the first year of life respect to those who declared to demand any decision to parents. Results Participation rate was 43.3% (350 of 808) among active members of the Italian Society of Primary Care Pediatricians (SICuPP), 213 of them (60.9%) choose DR and 137 (39.1%) NN as CF starting criterion. About 75% declared to counsel CF start between 5 and 6 months of age, 17% before 5 months and 8% after 6 months. Concerning CF modalities, 38% suggested Traditional pureed foods spoon feeding following written recommendations (T), 13% suggested a sort of Baby-led weaning (B) while the majority (49%) declared to use both according with family characteristics. Concerning specific advices, 89% declared to suggest meat quantity during the first year of life and 91% suggest to introduce added salt only after 12 months of age. A GPN was followed by 85% of them. NN Pediatricians had a significantly earlier CF starting, an higher use of T modality, meat quantity and added salt advices, and followed more frequently a GNP respect to DR Pediatricians (all p<0,0001). Conclusions Our data suggest that the criterion most considered for CF start might be associated with timing, modality and nutritional advices during the first year of life. Pediatricians following the developmental readiness position for CF start could less frequently give to parents adequate nutritional advices for hypertension and obesity prevention. An effort aimed to integrate new CF practices with adequate nutritional recommendations should be strongly encouraged.