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Specific studies

Evaluation of an online network for the collection of data for paediatric pharmacovigilance
Working with the Istituto Superiore di Sanità, 45 italian family paediatricians were connected to the network and collected data on more than 300 adverse reactions to drugs. The results of this study are published on The Lancet
(The Lancet 2000, 355 : 1613-1614)

Pharmacovigilance NSAIDs
Incidence of mucocutaneous syndromes following use of mefenamic acid and meclofenamic acid in the italian paediatric population
acido niflumico/morniflumato

An important retrospective cohort study which recruited more than 300 paediatricians throughout Italy. The results of study are published on Pediatrics
(Pediatrics; 2005, 116 : 26-33)

Chicken pox
Natural history of varicella
3000 cases of varicella were recruited and followed (clinically and therapeutically) by 93 family paediatricians throughout Italy in a 7 month period. This is the greatest caseload reported at an international level. The results of this study were presented at various international conferences (amongst which ICAAC) and sre published on Epidemiology and Annali di Igiene e Medicina di Comunità.
(Epidemiology; november 2003, 14: 99-102) (Ann. Igiene e Medicina di comunità; 2002, 14: 21-27)

Asthma in the paediatric age group: prevalence and therapeutic management in Italy’s paediatric population.
This study involved 40 family paediatricians distributed uniformly throughout Italy, based on the infant population. The natural history of over 1400 asthmatic children was studied and followed over the period of one year. The results of this study are published on European Annals of Allergy and Clinical Immunology
(Eu. Ann. of Allergy and Cl. Immunology; 2003, 36: 47-51)

The effect of exclusion of antihistamines from NHS reimbursement in Italy: a retrospective database analysis
The objective of this study was to evaluate the impact of the period (January 2003-March 2004) in which antihistamines were not reimbursed in Italy on resource utilisation (paediatric consultations, specialist consultation and hospitalisations) in patients with asthma and allergies.
Over 13,000 cases of asthma and 20,000 of allergic rhinitis were studied from January 2002 to December 2005. The results showed that the period in which the drugs were non reimbursable there was no increase in hospitalisations or specialist consultations despite a decrease in the number of prescriptions.The results were presente at the American Academy of Asthma Allergy and Immunology(AAAAI), Miami, 2006 conference

Acute gastroenteritis and intestinal occlusion
Incidence and Outcomes of Acute Gastroenteritis and Intussusception in Italian Children.
The objective of this retrospective cohort study, which uses data from the Pedianet database, was to evaluate the incidence and characteristics of gastroenteritis in the Italian paediatric population. In particular, to evaluate the incidence of acute gastroenteritis, rotavirus infection and intussusception.
More than 14,000 cases of gastroenteritis and 21 cases of intussusception were studied. The results of the study were presented at the European Society of Pediatric Infectious Disease Conference in Basel (2006) and are going to be published in the Pediatric Infectious Disease Journal.

Rotavirus REVEAL
Rotavirus gastroenteritis Epidemiology and Viral types in Europe Accounting for Losses in Public Health and Society Study
An important prospective study carried out in 7 European countries to study the epidemiology and clinical characteristics of rotavirus gastroenteritis, in general practice, in hospitals and in the emergency department. Padua was the coordinating centre in Italy, with 13 primary care paediatricians and the Department of Paediatrics with the operative coordination of SoSeTe. The quantity and quality of recruitment in Italy were excellent.
The results of this study are important (as seen by the number of publications generated) and gave the epidemiological data which defined the European guidelines for rotavirus vaccination which are being published by the European Center for Disease Control (ECDC), ESPID and ESPGHAN.
The data has been presented at numerous international conferences and the European results were published in a specific supplement on the prestigious Journal of Infectious Disease
(The Journal of Infectious Disease; 2007, 195:S 4-16, 17-25, 26-35, 36-44)
The Italian results are being published on Infection (the clinical study) and were published on PharmacoEconomia (the study on cost).
(PharmacoEconomia; 2007, 9 n.2: 103-111).

Upper respiratory tract infections
Acute respiratory infections in paediatric age.
The study terminated in May 2000 has collected information on more than 8000 children with acute respiratory infections. In a subgroup of 1300 children a swab was made for research on the Influenza virus (using the fast method). The results have been presented at many international conferences and published on Medico e Bambino
(Medico e Bambino; 2001, 20 : 121-122)

Passive smoking
The influence of certain environmental factors on a child’s development and on the incidence of certain paediatric diseases.
This is a case control study in which the effect of exposure to passive smoking on incidence of recurrent otitis, headache/migraine, sinusitis and pneumonia are studied. The study ended in spring 2001 and recruited over 1300 cases and controls. The results of this study are published on Medico e Bambino
(Medico e Bambino; 2003, 22 : 57-58)

Objective: Evaluate the one-year risk of asthma exacerbations among children receiving either montelukast [MON] or other controller [OTHER], including high-dose inhaled corticosteroid (h-d ICS) or ICS + long-acting beta agonist (LABA).

Quantitative analysis on the presence and diagnosis of the main zoonoses in the Veneto, Friuli Venezia Giulia and Trento and Bolzano area paediatric populations
Retrospective study carried out on the PEDIANET database in 2006 in collaboration with the
Istituto Zooprofilattico delle Venezie (Institute of zoonotic prophylaxis). The objective was to collect quantitative data on the main zoonoses particularly those with vector, parasitic and food transmission.
4477 cases of gastroenteritis with possible zoonotic transmission in children aged 0 to 15 years occurring between 2001 and 2005 were studied. The results were presented at various national and international conferences.

Rotavirus SPRIK
Family paediatrician-based surveillance to estimate the disease burden of Rotavirus gastroenteritis in children < 5 years of age in Europe.
The aim of the study is to evaluate the impact of rotavirus gastroenteritis in children less than 5 years of age by means of surveillance of activities of family paediatricians in 5 european countries. This prospective study was started in January 2006 in a group of paediatricians in Montebelluna and finished in april 2007.
At the end of the study 132 children had been enrolled (against the target of 100). Italy and Spain were the only two countries that recruited the expected number of children. Results of the study will be available at the end of 2007.
BMC Pediatr. 2012 May 31;12:58. doi: 10.1186/1471-2431-12-58.
Eur J Pediatr. 2011 Feb;170(2):213-22. doi: 10.1007/s00431-010-1289-1. Epub 2010 Sep 15.

Real world Evaluation of ChiLdren’s response to Initial Controller therapy (RE-CLIC)
(Evaluation of the severity of asthma in children starting controller therapy)
Objectives of the study were: evaluating the severity of asthma at the beginning of treatment, the risk of treatment failure within the first 6 months of starting, a comparison of risk of treatment failure of different possibile control therapies and risk factors for treatment failure.
The population being studied is paediatric subjects which start controller therapy for asthma, chosen from the Pedianet network. Recruitment ended in May 2007, with 600 subjects having been recruited compared to the 500 expected. These subjects will be followed up for at least 6 months from the prescription of the medication being studied.
The study started in January 2006 and finishes in December 2007.

Clinical management of acute gastroenteritis
Evaluation of the incidence and clinical management of children with acute gastroenteritis in Italy
Cases of acute gastroenteritis occurring between September 2001 and September 2004 will be extracted from the PEDIANET database and their management described.
The study started in June 2007 and should be finished by November 2007.

Intravenous antibiotics
Retrospective study to evacuate the prescription of injectable antibiotics in a population of children followed by family paediatricians in Padua
7193 antibiotic prescriptions, of which 125 (0.8%) injectable, prescribed over the period of one year (1996) were studied.

Asthma 2
Asthma in the paediatric age group: monitoring of clinical and therapeutic management of asthma.
This pilot study, with the aim of assessing the clinical and therapeutic management of asthma, involved 30 family pediatricians (FP) of Veneto. The study includes a retrospective phase (analysis of data and preparation of a report with the data collected from 2010 to June, 2011) and a prospective phase (to be made in the next 3 years).

Use of amoxicillin, amoxicillin/clavulanate and cefaclor in the Italian pediatric population.
The aim of this study is to show the pattern of use of these beta-lactams in an Italian pediatric population, considered by age and sex, with particular regard to indications, dosage regimens, duration of treatment and therapeutic switch. It was conducted a retrospective cohort study considering children up to 12 years old, included in the database Pedianet, who have received at least one prescription of amoxicillin, amoxicillin/clavulanate or cefaclor during the period from 1st January 2003 to 30th June 2007.
Journal of Pediatric Infectious Diseases 9 (2014) 1–9

Clinical manifestations and socioeconomic impact of influenza of healthy children in the community
To evaluate the total burden of influenza of healthy children in the community in order to analyze the cost of influenza in pediatric age. It was a prospective study of 21,986 children with influenza-like illness (ILI; n=6,988) carried out in the community between November 1st, 2008, and April 30th, 2009 in Italy.
(Journal of infection (2011) 62, 379-387)

Novartis dermatological study
The most common Paediatric Skin Disease in Italian children: prevalence, management and health care resource utilisation
Skin diseases represent about 15% of the access to paediatric emergency room and about 20% of consultations by primary care physicians. It was used data from a large population based network of family paediatricians (Pedianet) to estimate the prevalence and describe the management and health care utilisation of Italian children presenting to paediatric skin disease (PSD).

Otitis (GSK)
Epidemiological international, multicenter, observational cohort to evaluate the incidence and the clinical and economic impact of acute otitis media (AOM) in subjects between the ages of 0 and 5 years, in several European countries.
The aim of this study is to assess the incidence and the clinical and economical impact of AOM in several European countries between children with 0-5 years old. These results are very important to understand the potential importance for public health and the economy of pneumococcal conjugate vaccines, with significant efficacy against AOM.
It was performing an epidemiological cohort study, partly retrospective, international, multicenter and observational.
(Epidemiology & Infection, Page 1 of 11. © Cambridge University Press 2013, doi:10.1017/S0950268813002744)

Otitis (Pedianet)
Evaluation of the incidence and burden of Acute Otitis media in Italian children.
This retrospective study cohort performed includes all children 0-5 years of age who are registered with one of the family paediatricians who contributed data (including diaries) to the PEDIANET database during the study period (1st January 2004 - 31st December 2007). The aim of the study are: to assess the incidence of AOM and recurrent AOM in Italy, to describe the clinical presentation of AOM, to describe the clinical management of children with AOM, to evaluate possible risk factors for recurrent AOM and AOM to assess the hospitalization rate for AOM.

Effects of Galactooligosaccharides/Polydextrose (GOS/PDX) supplemented formula in preventing and modifying the history of allergy and acute infections in a population of infants at risk of atopy.
The aim of this study is to evaluate whether a specific prebiotic Galacto-oligosaccharide/Polydextrose (GOS/PDX) may have an effect in preventing atopic dermatitis and/or intestinal and/or respiratory infections in infants at risk of atopy. In infants with early onset dermatitis, the hypothesis will be tested that prebiotics reduce the severity of the disease. It is a prospective, double blind, randomised study comparing formula with 50/50 mixture of GOS/PDX (Enfamil Premium Infant1) versus standard formula (Enfamil Premium1).

Rotavirus Veneto
Disease burden of viral Gastroenteritis in a paediatric population in Italy
In this observational, prospective, family paediatrician-based, study, using an established Italian research network of family paediatrician (Pedianet) covering a well-defined number of patients in the Veneto Region of Italy, was estimated the incidence of RVGE leading to a FP visit among children <5 years of age in a well-defined Italian population.

Psychotropic drugs-AIFA
Use of psychotropic drugs and adverse reactions in the Italian pediatric population
The aim of this observational, prospective study of 24 months was the calculation of incidence and prevalence relative to the use of psychotropic drugs used in children. The cohort consisted of 300 paediatric patients included in the Pedianet’s database.

Study on the Utilization of Duloxetine
This multi-center, retrospective non-interventional cohort study is interested in conducting a drug utilization study specifically to assess off-label use of duloxetine and selected comparators in various age groups and in particular, children and adolescents. A recent Prescription Event Monitoring study in the U.K. provided to regulators suggested that the off-label use (both in adults and adolescents/children) in the UK is 1% or lower. However, a more geographically comprehensive study (at the EU level) is desired. This assessment will be conducted across several EU countries.

Impact of varicella vaccination in the Veneto Region of Italy on the varicella incidence in the pediatric population.
This study examined trends in varicella incidence and hospitalization rates before and after vaccine introduction, and applied statistical models to assess vaccine effectiveness. 44 pediatricians attended to the study accounting for 572.127 person-years from 2003 to 2010.
ELSEVIER, Vaccine 29 (2011) 9480–9487


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