Sleep habits and sleep disorders in Italian children and adolescents: a cross-sectional survey.

STUDY OBJECTIVES: The aim was to describe sleep habits and epidemiology of the most common sleep disorders in Italian children and adolescents. METHODS: This was a cross-sectional study in which parents of typically developing children and adolescents (1-18 years) completed an online survey available in Italy, gathering retrospective information focusing on sleep habits and disorders. RESULTS: Respondents were 4,321 typically developing individuals (48.6% females). Most of our sample did not meet the age-specific National Sleep Foundation recommendations for total sleep duration (31.9% of toddlers, 71.5% of preschoolers, 61.6% of school-age children, and 41.3% of adolescents). Napping was described in 92.6% of toddlers and in 35.2% of preschoolers. Regarding geographical differences, children and adolescents of northern Italy showed more frequent earlier bedtimes and rise times than their peers of central and southern Italy. The most frequently reported sleep disorder in our sample was restless sleep (35.6%), followed by difficulties falling asleep (16.8%), > 2 night awakenings (9.9%), and bruxism (9.6%). Data also suggest that longer screen time is associated with later bedtimes on weekdays in all age groups. CONCLUSIONS: The current study shows that Italian children are at risk of sleep disorders, particularly insufficient sleep, restless sleep, and difficulty falling asleep. The study also provides normative sleep data by age group in a large cohort of typically developing Italian children, emphasizing the importance of the developmentally, ecologically, and culturally based evaluation of sleep habits and disorders. CITATION: Breda M, Belli A, Esposito D, et al. Sleep habits and sleep disorders in Italian children and adolescents: a cross-sectional survey. J Clin Sleep Med. 2023;19(4):659-672.

Complementary Feeding Caregivers' Practices and Growth, Risk of Overweight/Obesity, and Other Non-Communicable Diseases: A Systematic Review and Meta-Analysis.

Several institutions propose responsive feeding (RF) as the caregivers' relational standard when nurturing a child, from breast/formula feeding onwards. Previous systematic reviews (SRs) on caregivers' feeding practices (CFPs) have included studies on populations from countries with different cultures, rates of malnutrition, and incomes, whereas this SR compares different CFPs only in healthy children (4-24 months) from industrialized countries. Clinical questions were about the influence of different CFPs on several important outcomes, namely growth, overweight/obesity, risk of choking, dental caries, type 2 diabetes (DM2), and hypertension. The literature review does not support any Baby Led Weaning's or Baby-Led Introduction to SolidS' (BLISS) positive influence on children's weight-length gain, nor their preventive effect on future overweight/obesity. RF-CFPs can result in adequate weight gain and a lower incidence of overweight/obesity during the first two years of life, whereas restrictive styles and coercive styles, two kinds of non-RF in CF, can have a negative effect, favoring excess weight and lower weight, respectively. Choking risk: failure to supervise a child's meals by an adult represents the most important risk factor; no cause-effect relation between BLW/BLISS/RF/NRCF and choking could be found. Risks of DM2, hypertension, and caries: different CFPs cannot be considered as a risky or preventive factor for developing these conditions later in life.

The Effective Management of Fever in Pediatrics and Insights on Remote Management: Experts' Consensus Using a Delphi Approach.

Background: Even after the publication of the 2017 update of Italian guidelines on treatment of fever in pediatrics, some fundamental questions are still open and new ones emerged during the COVID-19 pandemic. Objective: To assess the level of consensus among Italian pediatricians on different topics related to treatment of fever in children by using the Delphi technique. Methods: A Delphi study was undertaken between June and September 2021, when two questionnaires were consecutively sent to a panel of experts to be answered anonymously. An invitation to participate was sent to 500 pediatricians distributed over the whole national territory and 80 (16%) of them accepted to participate on a voluntary basis. The questionnaires were structured into three specific topics: "therapeutic appropriateness and management of the febrile child," "management of the febrile child in the presence of other diseases," and "future perspectives in remote management." Each topic had six statements. Results: A first-round questionnaire was sent to 80 accepting pediatricians from different Italian regions. Of the 72 respondents (23% working in hospitals and 72% outside), 33% were from northern, 12% central, and 55% southern Italy or islands. A second-round questionnaire was sent to the same 80 pediatricians and 69 of them responded, without significant differences for workplaces or geographical distribution as compared with the first questionnaire. Overall, 75 participants answered at least one of the two questionnaires. All the statements on the topics of "therapeutic appropriateness and management of the febrile child" and "future perspectives in remote management" reached the predefined cut off for consensus (75% or more). Only one statement on "management of the febrile child in the presence of other diseases" did not achieve the consensus even after the second round. Conclusions: Italian pediatricians agree on several aspects of treatment of febrile children and their expert opinions could support everyday decision process complementary to recommendations by regulatory agencies and guidelines.

Recommendations on Complementary Feeding as a Tool for Prevention of Non-Communicable Diseases (NCDs)-Paper Co-Drafted by the SIPPS, FIMP, SIDOHaD, and SINUPE Joint Working Group.

Adequate and balanced nutrition is essential to promote optimal child growth and a long and healthy life. After breastfeeding, the second step is the introduction of complementary feeding (CF), a process that typically covers the period from 6 to 24 months of age. This process is, however, still highly controversial, as it is heavily influenced by socio-cultural choices, as well as by the availability of specific local foods, by family traditions, and pediatrician beliefs. The Società Italiana di Pediatria Preventiva e Sociale (SIPPS) together with the Federazione Italiana Medici Pediatri (FIMP), the Società Italiana per lo Sviluppo e le Origine della Salute e delle Malattie (SIDOHaD), and the Società Italiana di Nutrizione Pediatrica (SINUPE) have developed evidence-based recommendations for CF, given the importance of nutrition in the first 1000 days of life in influencing even long-term health outcomes. This paper includes 38 recommendations, all of them strictly evidence-based and overall addressed to developed countries. The recommendations in question cover several topics such as the appropriate age for the introduction of CF, the most appropriate quantitative and qualitative modalities to be chosen, and the relationship between CF and the development of Non-Communicable Diseases (NCDs) later in life.

Diffusion of COVID-19 among children and adolescents during the second and third waves of the pandemic in Italy.

This paper explores COVID-19 diffusion among children and adolescents (up to 19 years old) in Italy using the publicly available data that were collected and released by the Italian National Institute of Health (ISS). We consider in more detail the so-called second and third waves of the pandemic in Italy and explore the relationship between schools opening and the diffusion of COVID-19, which is a highly debated topic in the recent reference literature. We analyse the dynamics of COVID-19 incidence in the country as a whole and in its individual regions. Moreover, we compare the regions in which different levels of restrictions were imposed during the pandemic as well as different school closure calendars. We found there to be a significant correlation between the dynamics of the COVID-19 infections among young people in Italy and school closures during both the second and the third waves of the pandemic. CONCLUSION: Specifically, we found school closures to have mitigated the spread of the infection, especially among patients between the ages of 14 and 19. WHAT IS KNOWN: • The relationship between the opening of schools and the diffusion of COVID-19 is a debated topic. • SARS-CoV-2 diffusion among school-aged adolescents is almost twice as that among children. • SARS-CoV-2 is a mild disease for infants and children. WHAT IS NEW: • We analysed original data on the diffusion of COVID-19 among children and adolescents in Italy. • We calculated incidence of COVID-19 with reference to school-age classes and compared over time in the whole country and in the regions of Italy. • We analysed incidence dynamics considering school closures and other restrictions imposed by the local and national authorities to limit virus diffusion.

Impact of COVID-19 lockdown on sleep in children with autism spectrum disorders.

STUDY OBJECTIVES: The impact of the COVID-19 outbreak on sleep of participants with autism spectrum disorder (ASD) was assessed. METHODS: Parents of 111 children and adolescents with ASD filled out an anonymous online survey shared via social media, investigating the sleep patterns and disturbances before and during the lockdown. RESULTS: The lockdown changed significantly the bedtime on weekdays in 57.8% of participants with ASD (56.9% delayed; 0.9% advanced) and the rise time in 69.2% (61.7% delayed and 7.5% advanced). Sleep duration varied on weekdays in 49.1% (24.1% increased; 25% decreased). During the lockdown, participants with ASD showed a significant increase of sleep disturbances, compared to the preceding period, especially falling asleep (35.1% vs 22.5%), anxiety at bedtime (22.5% vs 10.8%), sleep terrors (5.4% vs 0%), and daytime sleepiness (14.4% vs 3.6%). CONCLUSIONS: Lockdown affected sleep of patients with ASD, showing an increase of difficulty in falling asleep, anxiety at bedtime, sleep terrors, and daytime sleepiness. The outbreak of COVID-19 significantly worsened sleep disturbances of children with ASD. CITATION: Bruni O, Melegari MG, Breda M, et al. Impact of COVID-19 lockdown on sleep in children with autism spectrum disorders. J Clin Sleep Med. 2022;18(1):137-143.

Changes in sleep patterns and disturbances in children and adolescents in Italy during the Covid-19 outbreak.

OBJECTIVE: To examine the impact of home confinement during the COVID-19 pandemic on the sleep patterns and sleep disturbances in Italian children and adolescents. METHODS: Participants completed an anonymous online survey, shared via social media and targeting children and adolescents aged 1-18 years, subdivided into age groups: 1-3, 4-5, 6-12, and 13-18 years. Caregivers completed a modified version of the Sleep Disturbance Scale for Children (SDSC), along with demographic information. RESULTS: The final sample consisted of 4314 subjects: 2217 males (50.4%) and 2097 females (49.6%). Age group distribution was: 1-3 years 1263 (29.3%), 4-5 years 893 (20.7%), 6-12 years 1848 (42.8%) and 13-18 years 310 (7.2%). We found a significant delay in bedtime and risetime in all age groups. School-age children and adolescents experienced the most significant delay: weekday bedtime ≥23 was reported by 28.4% of 6- to 12-year-old children during lockdown vs. 0.9% before and by 63.5% vs. 12.3% of 13- to 18-year-old adolescents. Risetime was also delayed with most subjects waking up after 8 in all age groups and sleep duration increased in all groups but not in the younger group. The screen time (excluding online lessons) boosted during the lockdown, mainly in older children but also in younger children. Sleep disorders increased in all groups but not in adolescents. Younger groups had an increased prevalence of difficulty falling asleep, anxiety at bedtime, night awakenings, nightmares and sleep terrors. CONCLUSION: Our study demonstrates that confinement due to COVID-19 determined a big delay in sleep/wake schedule of children in all age groups as well as an increase of sleep disturbances in all groups but adolescents.

Paracetamol and Ibuprofen in the Treatment of Fever and Acute Mild-Moderate Pain in Children: Italian Experts' Consensus Statements.

Fever and pain are challenging symptoms in children and adolescents and are common reasons for consultations in primary care and hospital. Paracetamol and ibuprofen are currently the only recommended drugs for treating fever in Italy, but the therapeutic approaches are discrepant in the different settings. In Italy, paracetamol and ibuprofen are the most prescribed analgesics for acute mild-moderate pain in children; however, their use is often inappropriate in that fever is over-treated and pain is under-treated. An Italian board of experts analyzed the motivations for the misalignment between daily practice and guidelines of fever and acute mild-moderate pain management of the territory and hospitals. The expert opinion consensus process underscored the appropriate use of paracetamol and ibuprofen according to clinical scenarios, patients' profiles, and the safety features of the drugs. Although patients' profiles can indicate different benefits from paracetamol or ibuprofen, critical issues of fever and acute mild-moderate pain management persist in primary care and hospitals. These expert opinion consensus statements can be an across-the-board tool to harmonize the routine practice between the territory and hospitals, especially under special conditions (at-risk for dehydration, coagulation disorder patients, etc.). It can also promote educational activity about fever and acute mild-moderate pain management to enhance the milestones already achieved by Italian pediatricians.

Prevention of recurrent respiratory infections : Inter-society Consensus.

Recurrent respiratory infections (RRIs) are a common clinical condition in children, in fact about 25% of children under 1 year and 6% of children during the first 6 years of life have RRIs. In most cases, infections occur with mild clinical manifestations and the frequency of episodes tends to decrease over time with a complete resolution by 12 years of age. However, RRIs significantly reduce child and family quality of life and lead to significant medical and social costs.Despite the importance of this condition, there is currently no agreed definition of the term RRIs in the literature, especially concerning the frequency and type of infectious episodes to be considered. The aim of this consensus document is to propose an updated definition and provide recommendations with the intent of guiding the physician in the complex process of diagnosis, management and prevention of RRIs.

Pediatric nurses in pediatricians' offices: a survey for primary care pediatricians.

BACKGROUND: The role played by nurses in caring for children in pediatricians' officies in the community is crucial to ensure integrated care. In Italy, pediatricians are responsible for the health of children aged 0-14 years living in the community. This study aimed to describe Italian primary care pediatricians' opinions about the usefulness of several nursing activities that pediatric nurses could perform in pediatricians' offices. METHODS: An online survey with pediatricians working in primary care in Italy was conducted between April-December 2018. A 40-item questionnaire was used to assess four types of nursing activities: clinical care, healthcare education, disease prevention, and organizational activities. The answers ranged from 1 (not useful at all) to 6 (very useful). Moreover, three open-ended questions completed the questionnaire. RESULTS: Overall, 707 pediatricians completed the online survey. Participants were mainly female (63%), with a mean age of 57.74 (SD = 6.42). The presence of a pediatric nurse within the pediatrician's office was considered very useful, especially for healthcare education (Mean 4.90; SD 1.12) and disease prevention (Mean 4.82; SD 1.11). Multivariate analysis confirmed that pediatricians 'with less working experience', 'having their office in a small town', and 'collaborating with a secretary and other workers in the office' rated the nurse's activities significantly more useful. CONCLUSIONS: A pediatric nurse in the pediatrician's office can significantly contribute to many activities for children and their families in the community. These activities include clinical care, healthcare education, disease prevention, and the organizational processes of the office. Synergic professional activity between pediatricians and pediatric nurses could ensure higher health care standards in the primary care setting.

Inter-society consensus for the use of inhaled corticosteroids in infants, children and adolescents with airway diseases.

BACKGROUND: In 2019, a multidisciplinary panel of experts from eight Italian scientific paediatric societies developed a consensus document for the use of inhaled corticosteroids in the management and prevention of the most common paediatric airways disorders. The aim is to provide healthcare providers with a multidisciplinary document including indications useful in the clinical practice. The consensus document was intended to be addressed to paediatricians who work in the Paediatric Divisions, the Primary Care Services and the Emergency Departments, as well as to Residents or PhD students, paediatric nurses and specialists or consultants in paediatric pulmonology, allergy, infectious diseases, and ear, nose, and throat medicine. METHODS: Clinical questions identifying Population, Intervention(s), Comparison and Outcome(s) were addressed by methodologists and a general agreement on the topics and the strength of the recommendations (according to the GRADE system) was obtained following the Delphi method. The literature selection included secondary sources such as evidence-based guidelines and systematic reviews and was integrated with primary studies subsequently published. RESULTS: The expert panel provided a number of recommendations on the use of inhaled corticosteroids in preschool wheezing, bronchial asthma, allergic and non-allergic rhinitis, acute and chronic rhinosinusitis, adenoid hypertrophy, laryngitis and laryngospasm. CONCLUSIONS: We provided a multidisciplinary update on the current recommendations for the management and prevention of the most common paediatric airways disorders requiring inhaled corticosteroids, in order to share useful indications, identify gaps in knowledge and drive future research.

Inhaled corticosteroids use in childhood respiratory diseases: an italian survey on pediatricians' prescription habits.

BACKGROUND: A national consensus document on inhaled corticosteroids (ICS) use in childhood, produced by the main Italian pediatric scientific societies, has been recently released. The aim of this study was to gather information on the current pediatricians' ICS prescription habits in Italy for the management of the most common pediatric respiratory diseases, namely allergic rhinitis (AR), asthma, preschool wheezing and laryngitis. METHODS: From the 1st October 2018 to the 31st January 2019 a link to an online questionnaire was sent monthly through a newsletter to the members of the Italian Society of Pediatrics. The questionnaire included 18 items on ICS use in the most common pediatric respiratory diseases. Data collection and reporting was based on STROBE Statement Checklist for cross-sectional studies. RESULTS: One thousand-two questionnaires were returned from primary care pediatricians (39.1%), hospital pediatricians (38.7%), private practicers (16.4%), university pediatricians (3.1%) and Pediatrics residents (2.7%). We found a good adherence to the international guidelines on AR, with prevalent use of oral antihistamine (60.6%) in the secretive phenotype and nasal ICS in the obstructive phenotype (64.8%). In asthma exacerbations ICS are not used in 53.4% of cases, but they are used at high dose in 27.9% and at low dose in 18.7% of cases. In intermittent asthma, ICS are not chosen as a daily controller therapy in 54.1% of cases, while they are chosen as a low dose daily therapy in 44.5% of cases (high dose in 1.4%). In children with persistent asthma, ICS are chosen as a daily low dose therapy in 67.4% of cases and as a daily high dose therapy in 31%. In the management of preschool wheezing, when a long-term treatment is needed, ICS are chosen both alone and in association with antileukotrienes in 71.4% of cases. Children affected by recurrent asthma exacerbations and wheezing are closely followed up, in particular by their primary care pediatricians. The preference for certain molecules in the treatment of different respiratory diseases also emerged. CONCLUSIONS: Pediatricians' ICS prescription habits in Italy should be improved, especially in the management of asthma. Future surveys on a more numerous sample will be useful to analyze differences in prescription habits on the basis of pediatricians' work settings and geographical distribution.

Updated Guidelines for the Management of Acute Otitis Media in Children by the Italian Society of Pediatrics: Diagnosis.

BACKGROUND: In recent years, new progress has been made regarding the diagnosis, treatment and prevention of acute otitis media (AOM). The Italian Pediatric Society therefore decided to issue an update to the previous guidelines published in 2010. METHODS: Literature searches were conducted on MEDLINE by Pubmed, including studies in children, in English or Italian, published between January 1, 2010, and December 31, 2018. The quality of the included studies was assessed using the grading of recommendations, assessment, development and evaluations (GRADE) methodology. In particular, the quality of the systematic reviews was evaluated using the AMSTAR 2 appraisal tool. The guidelines were formulated using the GRADE methodology by a multidisciplinary panel of experts. RESULTS: The diagnosis of AOM is based on acute clinical symptoms and otoscopic evidence; alternatively, the presence of otorrhea associated with spontaneous tympanic membrane perforation allows the AOM diagnosis. The diagnosis of AOM must be certain and the use of a pneumatic otoscope is of fundamental importance. As an alternative to the pneumatic otoscope, pediatricians can use a static otoscope and a tympanometer. To objectively establish the severity of the episode for the formulation of a correct treatment program, an AOM severity scoring system taking into account clinical signs and otoscopic findings was developed. CONCLUSIONS: The diagnosis of AOM is clinical and requires the introduction of specific medical training programs. The use of pneumatic otoscopes must be promoted, as they are not sufficiently commonly used in routine practice in Italy.

Updated Guidelines for the Management of Acute Otitis Media in Children by the Italian Society of Pediatrics: diagnosis

In recent years, new progress has been made regarding the diagnosis, treatment and prevention of acute otitis media (AOM). The Italian Pediatric Society therefore decided to issue an update to the previous guidelines published in 2010. Literature searches were conducted on MEDLINE by Pubmed, including studies in children, in English or Italian, published between January 1, 2010, and December 31, 2018. The quality of the included studies was assessed using the grading of recommendations, assessment, development and evaluations (GRADE) methodology. In particular, the quality of the systematic reviews was evaluated using the AMSTAR 2 appraisal tool. The guidelines were formulated using the GRADE methodology by a multidisciplinary panel of experts. The diagnosis of AOM is based on acute clinical symptoms and otoscopic evidence; alternatively, the presence of otorrhea associated with spontaneous tympanic membrane perforation allows the AOM diagnosis. The diagnosis of AOM must be certain and the use of a pneumatic otoscope is of fundamental importance. As an alternative to the pneumatic otoscope, pediatricians can use a static otoscope and a tympanometer. To objectively establish the severity of the episode for the formulation of a correct treatment program, an AOM severity scoring system taking into account clinical signs and otoscopic findings was developed.The diagnosis of AOM is clinical and requires the introduction of specific medical training programs. The use of pneumatic otoscopes must be promoted, as they are not sufficiently commonly used in routine practice in Italy.

Understanding Discomfort in Order to Appropriately Treat Fever.

Although national and international guidelines on the management of childhood and adolescent fever are available, some inadequate practices persist, both from parents and healthcare professionals. The main goal of bringing children's temperature back to normal can lead to the choice of inappropriate drugs or non-necessary combination/alternation of antipyretic treatments. This behavior has been described in the last 35 years with the concept of fever-phobia, caused also by the dissemination of unscientific information and social media. It is therefore increasingly important that pediatricians continue to provide adequate information to parents in order to assess the onset of signs of a possible condition of the child's discomfort rather than focusing only on temperature. In fact, there is no clear and unambiguous definition of discomfort in literature. Clarifying the extent of the feverish child's discomfort and the tools that could be used to evaluate it would therefore help recommend that antipyretic treatment is appropriate only if fever is associated with discomfort.

Sleep and new media usage in toddlers.

Several studies over the years have demonstrated the association between lack of sleep in children and certain physical, psychological, and behavioral disorders. The aim of this study was to disentangle the association between new screen-based electronic devices and sleep problems in toddlers, adjusting for other covariates already known to be associated with sleep quality. We conducted a cross-sectional study with the aid of a national sample of 1117 toddlers. Parents reported children's sleeping habits such as total sleep time and sleep onset latency, recreational activities, bedtime routines, and temperament. An ordered logistic regression was run to assess the associations between new media exposure and two sleep outcomes (total sleep time and sleep onset latency). Everyday use of a tablet or smartphone raised the odds of a shorter total sleep time (OR 1.95 [1.00-3.79], p < 0.05) and a longer sleep onset latency (OR 2.44 [1.26-4.73] p < 0.05) irrespective of other factors, such as temperament (restlessness, sociability), or traditional screen exposure (watching TV or playing videogames).Conclusion: New media usage is a factor associated in toddlers with sleeping fewer hours and taking longer to fall asleep, irrespective of other confounding factors. What is known • Studies have found an association between sleep behavior and the use of computers and video games in early childhood. • The blue light emitted from TV screens suppresses endogenous melatonin. What is new • The study found an association between daily new media (tablet and smartphone) usage and sleep quality in toddlers • New media usage exposes toddlers to the risk of fewer hours of sleep and taking longer to fall asleep, irrespective of other factors.

Diagnosis, treatment and prevention of pediatric obesity: consensus position statement of the Italian Society for Pediatric Endocrinology and Diabetology and the Italian Society of Pediatrics.

The Italian Consensus Position Statement on Diagnosis, Treatment and Prevention of Obesity in Children and Adolescents integrates and updates the previous guidelines to deliver an evidence based approach to the disease. The following areas were reviewed: (1) obesity definition and causes of secondary obesity; (2) physical and psychosocial comorbidities; (3) treatment and care settings; (4) prevention.The main novelties deriving from the Italian experience lie in the definition, screening of the cardiometabolic and hepatic risk factors and the endorsement of a staged approach to treatment. The evidence based efficacy of behavioral intervention versus pharmacological or surgical treatments is reported. Lastly, the prevention by promoting healthful diet, physical activity, sleep pattern, and environment is strongly recommended since the intrauterine phase.

What not to do in acute otitis media: the top five recommendations proposed by the Italian Society of Preventive and Social Pediatrics.

INTRODUCTION: With the aim to reduce inappropriate procedures and antibiotic therapy in the management of acute otitis media (AOM) in children, the Italian Society of Preventive and Social Pediatrics (SIPPS) proposed a top five list of recommendations for clinical practice. Areas covered: AOM is one of the most frequent reasons for antibiotic prescription in pediatric age. The over-estimation of AOM is associated with inappropriate treatment, increased costs, adverse events and spread of antibiotic resistance. Thus, the most recent guidelines provided stringent diagnostic criteria and considered the 'watchful waiting' approach, limiting the immediate antibiotic therapy to a well-characterized subgroup of children. Expert commentary: The five recommendations proposed are: 1) Do not diagnose AOM without having documented the presence of middle ear effusion 2) Do not diagnose AOM without examining the entire tympanic membrane; 3) Do not treat immediately all cases of AOM with antibiotics; 4) Do not administer ear analgesic drops until examining the whole tympanic membrane 5) Do not use macrolides in the AOM therapy. This list of top five recommendations could be a novel tool to spread the key messages on the guidelines and to promote the correct diagnostic procedures as well as a rational use of antibiotics in children.

Pharmacological interventions on early functional gastrointestinal disorders.

BACKGROUND: Functional gastrointestinal disorders (FGIDs) are chronic or recurrent gastrointestinal symptoms without structural or biochemical abnormalities. FGIDs are multifactorial conditions with different pathophysiologic mechanisms including altered motility, visceral hyperalgesia, brain-gut disturbance, genetic, environmental and psychological factors. Although in most cases gastrointestinal symptoms are transient and with spontaneous resolution in infancy multiple dietary changes and pharmacological therapy are often started despite a lack of evidence-based data. Our aim was to update and critically review the current literature to assess the effects and the clinical appropriateness of drug treatment in early (occurring in infants and toddlers) FGIDs. METHODS: We systematically searched the Medline and GIMBE (Italian Group on Medicine Based on Evidence) databases, according to the methodology of the Critically Appraised Topics (CATs). We included reviews, clinical studies, and evidence-based guidelines reporting on pharmacological treatments. Systematic reviews and randomized controlled trials (RCTs) concerning pharmacologic therapies in children with early FGIDs were included, and data were extracted on participants, interventions, and outcomes. RESULTS: We found no evidence-based guidelines or systematic reviews about the utility of pharmacological therapy in functional regurgitation, infant colic and functional diarrhea. In case of regurgitation associated with marked distress, some evidences support a short trial with alginate when other non pharmacological approach failed (stepped-care approach). In constipated infants younger than 6 months of age Lactulose is recommended, whilst in older ages Polyethylene glycol (PEG) represents the first-line therapy both for fecal disimpaction and maintenance therapy of constipation. Conversely, no evidence supports the use of laxatives for dyschezia. Furthermore, we found no RCTs regarding the pharmacological treatment of cyclic vomiting syndrome, but retrospective studies showed a high percentage of clinical response using cyproheptadine, propanolol and pizotifen. CONCLUSION: There is some evidence that a pharmacological intervention is necessary for rectal disimpaction in childhood constipation and that PEG is the first line therapy. In contrast, for the other early FGIDs there is a lack of well-designed high-quality RCTs and no evidence on the use of pharmacological therapy was found.