Paola Marchisio

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Milano, Lombardy, Italy

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Publications (49)188.23 Total impact

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    Article: Panel 7: treatment and comparative effectiveness research.
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    ABSTRACT: Background and Objectives Otitis media (OM) is one of the most common reasons for antibiotic treatment in children. Controversies regarding antibiotic treatment for OM have accumulated in the past decade, and there seem to be more dilemmas than certainties. The objectives of this article are to provide the state-of-the art review on achievements in treatment of all different stages of OM, including acute otitis media (AOM), otitis media with effusion (OME), and chronic suppurative otitis media, and to outline the future research areas. Data Sources PubMed, Ovid Medline, the Cochrane Database, and Clinical Evidence (BMJ Publishing). Review Methods All types of articles related to OM treatment published in English between January 2007 and June 2011 were identified. A total of 286 articles related to OM treatment were reviewed by the panel members; 114 relevant quality articles were identified and summarized. Results New evidence emerged on beneficial results of antibiotic treatment, compared with observation of AOM in young children who were diagnosed based on stringent criteria. In OME, the main results were related to a nonsignificant benefit of adenoidectomy versus tympanostomy tube placement alone in the treatment of chronic OME in younger children. Other modalities of OM treatment were studied and described herein. Conclusions and Implications for Practice Significant progress has been made in advancing the knowledge on the treatment of OM. Areas of potential future research have been identified and outlined.
    Otolaryngology Head and Neck Surgery 04/2013; 148(4 Suppl):E102-21. · 1.72 Impact Factor
  • Article: Nasopharyngeal fiberendoscopy in children: A diagnostic challenge in current clinical practice: How we do it.
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    ABSTRACT: OBJECTIVE: Nasopharyngeal fiberendoscopy (NFE) is the gold standard diagnostic procedure in children with suspected adenoidal disease, but it is not always easily feasible in younger children, and there is no consensus on the optimal technical approach according to children's age or disease. This paper aims to report our experience with NFE performed during routine paediatric clinical examination, also with regards to tolerability and patients' satisfaction. METHODS: NFE was performed in paediatric patients with suspected adenoidal obstruction by means of a 2.7mm-diameter flexible endoscope with the child seated in a chair or on parent's knees under outpatients basis and without administering local decongestants, anaesthetic agents, or sedatives. Relationship between possible confounders and patients' satisfaction, NFE tolerability, or needing for restraining was evaluated. RESULTS: NFE was successfully performed in all but one syndromic 2-year old patient. Analysis was conducted on 191 children (mean age=5.58; standard error, SE=2.52 years). Restraining was required more frequently (p<0.001) in younger children; NFE tolerability was good, as documented by mean visual analogue scale (VAS) values of 2.06 (SE=1.58), and a better NFE tolerance was reported more frequently (p<0.001) in older children. No significant relationship was found between needing for restraining or VAS and gender. No major or minor adverse events occurred. CONCLUSIONS: Our results support the feasibility and tolerability of flexible NFE performed by a skilled ENT specialist for nasopharyngeal evaluation in children aged more than 2 years with suspected adenoidal disease.
    International journal of pediatric otorhinolaryngology 02/2013; · 0.85 Impact Factor
  • Article: Topographic distribution of biofilm-producing bacteria in adenoid subsites of children with chronic or recurrent middle ear infections.
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    ABSTRACT: Bacterial biofilms have been found in the adenoids of children with recurrent acute otitis media (AOM) and persistent otitis media with effusion (OME). However, the possible difference in biofilm-producing bacteria (BPBs) between the adenoid surface at the nasopharyngeal dome (ND) and near the ostium of the eustachian tube (ET) has not been investigated. This study aimed to assess the difference in BPBs between adenoid biopsy specimens of the ND and those taken near the pharyngeal ostium of the ET in children with chronic adenoiditis with recurrent AOM and/or persistent OME. We collected adenoid biopsy specimens from the ND and ET during transoral endoscopic adenoidectomy to assess BPB by means of spectrophotometric analysis. We collected 135 adenoid biopsy specimens from 45 children. BPBs were detected significantly (p = 0.04) more frequently in the ET samples than in the ND samples, mainly Staphylococcus aureus. Although the prevalence of S aureus was slightly greater in the ND samples, and that of Streptococcus pneumoniae and Moraxella catarrhalis was slightly greater in the ET samples, these differences were not statistically significant. The fact that BPBs were significantly more frequently located near the ostium of the ET suggests that the adenoids are a reservoir for bacteria and indicates that hypertrophic adenoids (particularly hypertrophy near the ostium of the ET) play a role in recurrent AOM and/or OME.
    The Annals of otology, rhinology, and laryngology 02/2013; 122(2):109-13. · 1.05 Impact Factor
  • Article: Impact of vitamin D administration on immunogenicity of trivalent inactivated influenza vaccine in previously unvaccinated children.
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    ABSTRACT: As vitamin D (VD) has a significant regulatory effect on innate and adaptive immunity, the aim of this prospective, randomized, single-blinded, placebo-controlled study was to measure the impact of VD administration on the immune response to trivalent influenza vaccination (TIV). A total of 116 children (61 males, 52.6%; mean age 3.0 ± 1.0 y) with a history of recurrent acute otitis media (AOM), who had not been previously vaccinated against influenza, were randomized to receive daily VD 1,000 IU or placebo by mouth for four months. All of them received two doses of TIV (Fluarix, GlaxoSmithKline Biologicals) one month apart, with the first dose administered when VD supplementation was started. There was no difference in seroconversion or seroprotection rates, or antibody titers, in relation to any of the three influenza vaccine antigens between the VD and placebo groups, independently of baseline and post-treatment VD levels. The safety profile was also similar in the two groups. These data indicate that the daily administration of VD 1,000 IU for four months from the time of the injection of the first dose of TIV does not significantly modify the antibody response evoked by influenza vaccine.
    Human vaccines & immunotherapeutics. 01/2013; 9(5).
  • Article: Recurrences in chronic tonsillitis substained by tonsillar biofilm-producing bacteria in children. Relationship with the grade of tonsillar hyperplasy.
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    ABSTRACT: OBJECTIVES: It has been suggested that bacterial biofilms are involved in chronic tonsillar disease, but there is a lack of strong evidence concerning their etiopathogenic role in childhood chronic tonsillar infections. The aim of this study was to assess the presence of biofilm-producing bacteria (BPB) in tonsillar bioptic specimens taken from children with recurrent exacerbations of chronic hyperplastic tonsillitis, and to evaluate the possible relationship between them and the patients' demographic and clinical characteristics. METHODS: 22 children (68.2% males; median age 6.5 years, range 3-13) with recurrent exacerbations of chronic hyperplastic tonsillitis were included. The presence of tonsillar BPB was assessed by means of the spectrophotometric analysis of tonsillar bioptic specimens taken during tonsillectomy between episodes of tonsillar infection. RESULTS: BPB were found in 50.0% of the 44 tonsillar specimens, and Staphylococcus aureus was the most frequent pathogen (81.8%). There was a significant relationship (p=0.02) between the grade of tonsillar hyperplasy (GTH) and the presence of tonsillar BPB, with an increased relative risk (RR=4.27, standard error=2.57, p<0.01) of tonsillar BPB development in children with GTH scores of >2. CONCLUSIONS: The findings of this study: (1) confirm the presence of tonsillar BPB in children with recurrent exacerbations of chronic tonsillar infections; (2) suggest that GTH is an important indicator of the presence of tonsillar BPB; and (3) raise the question as to whether tonsillar biofilm is a causative factor or just a consequence of recurrent exacerbations of chronic hyperplastic tonsillitis.
    International journal of pediatric otorhinolaryngology 11/2012; · 0.85 Impact Factor
  • Article: Management of acute pharyngitis in children: summary of the Italian National Institute of Health guidelines.
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    ABSTRACT: Discrepancies in the management of pharyngitis in children have been reported in Europe and the United States, and recommendations concerning the use of clinical scores, rapid antigen diagnostic tests (RADTs) or throat cultures, and the indications for antibiotic treatment largely differ. This article summarizes the Italian guidelines on the management of pharyngitis in children issued by the National Institute of Health. A multidisciplinary panel of experts (the Guidelines Development Group) developed and used a set of key questions to conduct a systematic review of the literature. Relevant publications in English were identified through a systematic review of MEDLINE and the Cochrane Database of Systematic Reviews from their inception through April 30, 2011. Final recommendations were scaled according to the Italian National Guidelines Program grading. Eighteen clinical questions were defined, and 44 recommendations were issued. None of the available scoring systems is sufficiently accurate to identify group A β-hemolytic streptococci (GABHS) pharyngitis in settings with low prevalence for rheumatic disease. RADT should be performed by trained personnel in every child with a history and signs/symptoms suggestive of GABHS pharyngitis. RADT is not recommended in children with a McIsaac score of 0 or 1 with ≥2 signs/symptoms suggestive of viral infection. Backup culture in children with negative RADT result is not recommended. Culture test with antibiotic susceptibility assay should be performed exclusively for epidemiologic purposes. Streptococcal antibody titers are of no value in diagnosing acute pharyngitis. Antibiotic therapy is recommended in microbiologically documented GABHS pharyngitis. Because penicillin V is not available in Italy, amoxicillin (50 mg/kg/d in 2-3 doses orally) for 10 days is the first choice of treatment. In noncompliant cases, benzathine penicillin may be administered. Although not routinely recommended due to the high cost and wide spectrum of activity, a 5-day course with a second-generation cephalosporin may be used in noncompliant cases. Macrolides should be limited to children with demonstrated type I hypersensitivity to penicillin. Ibuprofen or paracetamol is recommended for relief of pain or fever associated with discomfort. Because the carrier state is not associated with increased risk of suppurative complications and risk of GABHS transmission to contacts is minimal, the carrier state should never be investigated and treated. Recommendations for the management of suppurative complications are given. This guideline provides a comprehensive, evidence based, tool for the diagnosis and therapy of acute pharyngitis in children.
    Clinical Therapeutics 06/2012; 34(6):1442-1458.e2. · 2.32 Impact Factor
  • Article: Biofilm formation by bacteria isolated from upper respiratory tract before and after adenotonsillectomy.
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    ABSTRACT: Failure of antibiotics to eradicate the microbial pathogens primarily responsible for otorhinolaryngological diseases has led to the hypothesis that these microorganisms may be structured in a biolfilm. Aim of the study was to evaluate the ability to produce biofilm among bacteria isolated from tonsils and/or adenoids and nasopharynx. Biopsies and swabs were collected during surgery and after 3 and 6 months in 32 children undergoing adenoidectomy and/or tonsillectomy. Production of biofilm by Staphylococcus aureus, Streptococcus pneumoniae, Moraxella catarrhalis and Haemophilus influenzae was evaluated in vitro by means of spectrophotometry after growth in microplates and staining with crystalviolet. Of the isolates from intraoperative samples, 44.7% were either moderate or strong biofilm producers compared with 27% of isolates at 6 months after surgery. A decrease in biofilm production was observed for H. influenzae and S. aureus. In conclusion, the rate of isolation and ability to form biofilm decreased in bacteria isolated subsequent to adenoidectomy and/or tonsillectomy. This suggests a role for biofilm in pathogenesis of recurrent and chronic pharyngeal diseases and rhinopharingitis.
    Apmis 05/2012; 120(5):410-6. · 1.99 Impact Factor
  • Article: Nasopharyngeal biofilm-producing otopathogens in children with nonsevere recurrent acute otitis media.
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    ABSTRACT: Bacterial biofilms have been detected in biopsies of the adenoid and middle ear mucosa of otitis-prone children and children with chronic middle otitis media. However, the invasiveness of biopsy makes it unsuitable for routine clinical practice, especially in pediatrics. This study aimed to investigate nasopharyngeal biofilm-producing otopathogens (BPOs) of nasopharyngeal swabs (NPS) in children with a history of nonsevere recurrent acute otitis media (RAOM) and healthy controls. A cross-sectional study with planned data collection. University of Milan. Transoral NPS were taken from infants and children aged 10 months to 11 years with nonsevere RAOM or healthy controls without adenoid hypertrophy. Nasopharyngeal colonization by otopathogens was assessed by means of microbiological cultures and standard bacterial identification, as well as nasopharyngeal BPOs by means of spectrophotometric analysis. The study involved 113 children (56.6% males; median age 40 months; range, 10-132 months): 58 with a history of nonsevere RAOM (51.3%) and 55 controls (48.7%). Otopathogens were significantly more frequently detected in the RAOM group (24/58, 41.4%) than in controls (8/55, 14.5%; P = .003); the main pathogens were respectively Haemophilus influenzae (12/24, 50.0%) and Streptococcus pyogenes (3/8, 37.5%). Nasopharyngeal BPOs were more frequently isolated in the RAOM group (17/58, 29.3%) than in controls (6/55, 10.9%; P = .02). H influenzae (12/17, 70.6%) was confirmed as the main pathogen in the RAOM group. The presence of nasopharyngeal BPOs is an important factor favoring RAOM; it is therefore useful investigating biofilms even in children with nonsevere recurrences of AOM without adenoid hypertrophy.
    Otolaryngology Head and Neck Surgery 02/2012; 146(6):991-6. · 1.72 Impact Factor
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    Article: The immunogenicity and safety of a single 0.5mL dose of virosomal subunit influenza vaccine administered to unprimed children aged ≥6 to <36 months: Data from a randomized, Phase III study.
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    ABSTRACT: Vaccine j o u r n a l h o m e p a g e : w w w . e l s e v i e r . c o m / l o c a t e / v a c c i n e The immunogenicity and safety of a single 0.5 mL dose of virosomal subunit influenza vaccine administered to unprimed children aged ≥6 to <36 months: Data from a randomized, Phase III study 1 2 3 20 Available online xxx 21 Keywords: 22 Influenza 23 Virosomal 24 Children 25 Vaccination schedule 26 Immunogenicity 27 a b s t r a c t This study evaluated the immunogenicity, safety and tolerability of a single 0.5 mL dose of the seasonal virosomal subunit influenza vaccine (Inflexal V, Crucell, Switzerland) in 205 healthy, unprimed children aged at least 6 to <36 months, evaluated at four weeks post-vaccination and seven months from baseline. Of the enrolled children, 102 received one single 0.5 mL dose and 103 received the standard two 0.25 mL doses given four weeks apart. Both treatments evoked an immune response that satisfied the EMA/CHMP criteria for yearly vaccine licensing for all three vaccine strains. Exploratory analyses revealed no differ-ences between the groups at four weeks post-vaccination. Furthermore, immunogenicity was maintained seven months after the first vaccination after both the 0.5 mL and standard two 0.25 mL doses. Adverse events were comparable between groups and were as expected according to the safety profile of the vaccine; overall, the vaccine was well tolerated. Our results show that a single 0.5 mL dose effectively and safely provided long-term immunogenicity to all three influenza strains in unprimed children aged at least 6 to <36 months.
    Vaccine 01/2012; · 3.77 Impact Factor
  • Article: Clinical and socioeconomic impact of pediatric seasonal and pandemic influenza.
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    ABSTRACT: Influenza is frequent among otherwise healthy day-care and school-aged children. Recent studies have demonstrated its significant effect on various outcome factors, including significantly more school and parental work absenteeism, and secondary illnesses among family members. Other studies have shown that the potential benefit of vaccinating children against influenza extends to other members of their families, thus supporting earlier economic modeling analyses of immunization programs. Although there are some differences in the clinical and socio-economic impact of seasonal and pandemic influenza, the benefits of vaccination are similar in both cases. The vaccination of otherwise healthy children may significantly reduce direct and indirect influenza-related costs, which supports the recommendation to make wider use of influenza vaccine in healthy children of any age in order to reduce the burden of infection on the community.
    Human vaccines & immunotherapeutics. 01/2012; 8(1):17-20.
  • Article: Treatment of acute otitis media in children.
    Nicola Principi, Susanna Esposito, Paola Marchisio
    New England Journal of Medicine 05/2011; 364(18):1777; author reply 1777-9. · 53.30 Impact Factor
  • Article: Antibiotic treatment of acute otitis media in pediatrics.
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    ABSTRACT: Evaluation of: Hoberman A, Paradise JL, Rockette HE et al.: Treatment of acute otitis media in children under 2 years of age. N. Engl. J. Med. 364, 105-115 (2011). A recently published study by Hoberman et al. concluded that 10 days' treatment with amoxicillin-clavulanate tended to reduce the overall symptom burden, the time to symptom resolution, and the rate of persistent signs of acute infection upon otoscopic examination in children aged 6-23 months with acute otitis media (AOM). This study seems to put an end to the controversy between American and European experts concerning the best approach to the treatment of AOM in younger children. However, although treating all children aged less than 2 years with antimicrobial drugs is the lesser of two evils, it is not an ideal solution. Furthermore, the future more widespread use of some already available vaccines against respiratory pathogens could significantly reduce the total number of new episodes of AOM, thus limiting the risk of therapeutic error.
    Future Microbiology 05/2011; 6(5):485-8. · 3.82 Impact Factor
  • Article: Present and future of influenza prevention in pediatrics.
    Nicola Principi, Susanna Esposito, Paola Marchisio
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    ABSTRACT: INTRODUCTION: Pediatric influenza not only leads to significant rates of morbidity and an increased risk of hospitalisation, it can also have a substantial socio-economic impact because children shed larger amounts of viruses over longer periods than adults. This makes adequate prevention desirable, and the best means of reducing the incidence and risks of infection in children is influenza vaccination. AREAS COVERED: The main aim of this review is to analyse the characteristics of new means of influenza prevention and identify which may be important in pediatrics. An updated overview of influenza vaccines is provided, concentrating on strategies of inducing immunogenicity and facilitating the administration of both old and new vaccines. EXPERT OPINION: The currently available data clearly indicate that influenza in children is much less optimally prevented than other vaccine-preventable diseases. A number of different approaches seem to be promising in adults, but there is an urgent need for new strategies when using old vaccines in children or testing new vaccines in pediatric trials.
    Expert opinion on biological therapy 03/2011; 11(5):641-53. · 3.22 Impact Factor
  • Article: Knowledge of oxygen administration, aerosol medicine, and chest physiotherapy among pediatric healthcare workers in Italy.
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    ABSTRACT: Oxygen administration, aerosol devices and drugs, or the use of chest physiotherapy are common practices in pediatrics; however, little is known about the knowledge of pediatric healthcare workers concerning the right utilization of these tools. The aim of this study was to fill this gap as a preliminary step in the implementation of appropriate educational programs. This cross-sectional survey of a nationally representative sample of Italian pediatricians and nurses was carried out between September 1 and October 8, 2008. A self-administered, anonymous questionnaire concerning the approach to respiratory disease in infants and children was distributed to all of the participants at the Annual Congress of the Italian Society of Pediatrics, together with a stamped envelope addressed to the trained study researchers. Of the 900 distributed questionnaires, 76.7% were completed and returned by 606 physicians (199 primary care pediatricians, 245 hospital pediatricians, and 162 pediatric residents) and 84 pediatric nurses. The vast majority of the respondents did not know the percentage of hemoglobin saturation indicating hypoxemia that requires oxygen administration. Most of the nurses admitted to overusing mucolytics and inhalatory corticosteroids, did not know the role of ipratropium bromide, were unable to indicate the first-line drug for respiratory distress, and did not know the correct dose of salbutamol. Only a minority of the respondents were able to specify the indications for chest physiotherapy. The nurses gave the fewest correct answers regardless of their age, gender, work setting, or the frequency with which they cared for children with respiratory distress in a year cared. The knowledge of primary care pediatricians, hospital pediatricians, and pediatric nurses in Italy concerning the use of pulse oximetry, aerosol devices and drugs, and chest physiotherapy is far from satisfactory and should be improved. Educational programs are therefore required for both nurses and pediatricians.
    Journal of Aerosol Medicine and Pulmonary Drug Delivery 03/2011; 24(3):149-56. · 2.20 Impact Factor
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    Article: Diagnostic accuracy of nasopharyngeal swabs in detecting biofilm-producing bacteria in chronic adenoiditis: a preliminary study.
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    ABSTRACT: Biofilms are organized bacterial communities that are playing an increasing role in otolaryngological diseases such as chronic or recurrent middle ear otitis and adenotonsillitis. Various cultural techniques are available to detect biofilm-producing bacteria (BPB), but microbiological analysis of bioptic staining is the reference diagnostic procedure. To our knowledge, the accuracy of nasopharyngeal swabs in diagnosing BPB has never been assessed. A prospective study of diagnostic accuracy. Outpatient clinics of the Departments of Specialist Surgical Sciences and Maternal and Pediatric Sciences, University of Milan, Italy. Forty-two pediatric subjects with chronic adenoiditis (aged 4-18 years) underwent adenoidectomy, during which multiple transoral nasopharyngeal swabs and adenoidal biopsies were performed. BPB were detected by spectrophotometry, and the accuracy of detecting BPB in nasopharyngeal swabs was compared with that of biopsy. BPB were detected in 73.8% of the nasopharyngeal swabs and in 69.1% of the biopsies. The sensitivity and specificity of the nasopharyngeal swabs were, respectively, 75.9% (95% confidence interval [CI], 60.3%-91.4%) and 30.8% (95% CI, 5.7%-55.9%); positive and negative predictive values were, respectively, 71.0% (95% CI, 55.0%-86.9%) and 36.4% (95% CI, 7.9%-64.8%); and the area under the receiver-operating characteristic curve was 0.5 (95% CI, 0.4-0.7). In comparison with biopsy, nasopharyngeal swabs seem to be inaccurate in detecting BPB and should be cautiously used in clinical practice. As these preliminary findings may have been due to the well-known resistance of biofilm to mechanical injuries (such as swab rubbing) or the small study population, they need to be confirmed in larger patient series.
    Otolaryngology Head and Neck Surgery 02/2011; 144(5):784-8. · 1.72 Impact Factor
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    Article: Acute otitis media: From diagnosis to prevention. Summary of the Italian guideline.
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    ABSTRACT: Acute otitis media (AOM) is the most common disease occurring in infants and children and has major medical, social and economic effects. If we consider the Italian pediatric population and the incidence rates in different age ranges it can be calculated that almost one million cases of AOM are diagnosed in Italy every year. Various attempts have been made internationally to clarify the most appropriate ways in which AOM should be managed. In Italy, this has been done at local or regional level but there have so far been no national initiatives. The objective of this guideline is to provide recommendations to pediatricians, general practitioners and otolaryngologists involved in the clinical management of acute otitis media in healthy children aged 2 months to 12 years. After a systematic review and grading of evidences from the literature, the document was drafted by a multidisciplinary panel with identified key clinical questions related to diagnosis, treatment of the acute episode, management of complications and prevention.
    International journal of pediatric otorhinolaryngology 11/2010; 74(11):1209-16. · 0.85 Impact Factor
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    Article: Altered cardiac rhythm in infants with bronchiolitis and respiratory syncytial virus infection.
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    ABSTRACT: Although the most frequent extra-pulmonary manifestations of respiratory syncytial virus (RSV) infection involve the cardiovascular system, no data regarding heart function in infants with bronchiolitis associated with RSV infection have yet been systematically collected. The aim of this study was to verify the real frequency of heart involvement in patients with bronchiolitis associated with RSV infection, and whether infants with mild or moderate disease also risk heart malfunction. A total of 69 otherwise healthy infants aged 1-12 months with bronchiolitis hospitalised in standard wards were enrolled. Pernasal flocked swabs were performed to collect specimens for the detection of RSV by real-time polymerase chain reaction, and a blood sample was drawn to assess troponin I concentrations. On the day of admission, all of the infants underwent 24-hour Holter ECG monitoring and a complete heart evaluation with echocardiography. Patients were re-evaluated by investigators blinded to the etiological and cardiac findings four weeks after enrollment. Regardless of their clinical presentation, sinoatrial blocks were identified in 26/34 RSV-positive patients (76.5%) and 1/35 RSV-negative patients (2.9%) (p < 0.0001). The blocks recurred more than three times over 24 hours in 25/26 RSV-positive patients (96.2%) and none of the RSV-negative infants. Mean and maximum heart rates were significantly higher in the RSV-positive infants (p < 0.05), as was low-frequency power and the low and high-frequency power ratio (p < 0.05). The blocks were significantly more frequent in the children with an RSV load of ≥100,000 copies/mL than in those with a lower viral load (p < 0.0001). Holter ECG after 28 ± 3 days showed the complete regression of the heart abnormalities. RSV seems associated with sinoatrial blocks and transient rhythm alterations even when the related respiratory problems are mild or moderate. Further studies are needed to clarify the mechanisms of these rhythm problems and whether they remain asymptomatic and transient even in presence of severe respiratory involvement or chronic underlying disease.
    BMC Infectious Diseases 10/2010; 10:305. · 3.12 Impact Factor
  • Article: A randomized clinical trial assessing immunogenicity and safety of a double dose of virosomal-adjuvanted influenza vaccine administered to unprimed children aged 6-35 months.
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    ABSTRACT: This study evaluated the immunogenicity of a double dose of the seasonal virosomal-adjuvanted influenza vaccine (Inflexal V, Crucell, The Netherlands) in 65 previously unvaccinated children aged less than 3 years: 43 received double doses (two doses of 0.50 mL 4 weeks apart) and 22 standard doses (two doses of 0.25 mL 4 weeks apart). Both treatments evoked a response that satisfied the EMEA criteria for adequate immunogenicity for all three vaccine strains, but the double dose had a significantly greater effect on all of the studied parameters of humoral and cell-mediated immune response (p<0.05). This result was achieved without any increase in the incidence of local and systemic adverse events. This means that doubling the dose of the virosomal-adjuvanted influenza vaccine (i.e. administering the same dose as that usually given to older children) effectively and safely increases the immune response to inactivated influenza vaccine in unprimed children aged less than 3 years.
    Vaccine 08/2010; 28(38):6137-44. · 3.77 Impact Factor
  • Article: Clinical assessment of adenoidal obstruction based on the nasal obstruction index is no longer useful in children.
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    ABSTRACT: To evaluate the accuracy of clinical assessment of adenoidal obstruction based on a standardized score of the degree of mouth breathing and speech hyponasality (nasal obstruction index [NOI]) in comparison to nasal fiberoptic endoscopy. Cross-sectional study with planned data collection. Outpatient clinics of the Departments of Maternal and Pediatric Sciences and Specialized Surgical Sciences, University of Milan, Italy. Children aged three to 12 years with adenoidal obstruction suspected on the grounds of persistent/recurrent otitis media or perceived obstructive nasal breathing were eligible. Ear, nose, and throat examination, allergy testing, NOI measurement, and nasal fiberoptic endoscopy to assess the degree of adenoidal hypertrophy were performed. Agreement between the NOI and adenoidal hypertrophy grade was assessed in the patients as a whole and by clinical subgroups. A total of 202 children were enrolled: 54.9 percent had otological diseases and 45.1 percent had perceived obstructive nasal breathing. Most of the children (79.2%) showed mild or moderate clinical nasal obstruction. Adenoidal hypertrophy ranged from no obstruction (18%) to severe obstruction (38%). There was no substantial agreement between the NOI and the degree of adenoidal obstruction in the population as a whole and in all the clinical subgroups. False positive findings were significantly more frequent among allergic children (50%) than non-allergic children (22.4%, P = 0.009). Clinical assessment based on the NOI is incapable of accurately predicting the degree of adenoidal obstruction. In children with clinical nasal obstruction not explainable by adenoidal size, the clinician should consider, among causes of more anterior obstruction, nasal allergy.
    Otolaryngology Head and Neck Surgery 02/2010; 142(2):237-41. · 1.72 Impact Factor
  • Article: Collection by trained pediatricians or parents of mid-turbinate nasal flocked swabs for the detection of influenza viruses in childhood.
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    ABSTRACT: This study evaluated the efficiency of pediatric mid-turbinate nasal flocked swabs used by parents in 203 children aged 6 months to 5 years with signs and symptoms of respiratory disease. Two nasal samples were collected from each child in a randomised sequence: one by a trained pediatrician and one by a parent. The real-time polymerase chain reaction influenza virus detection rates were similar in the samples collected using the two methods (Cohen's kappa = 0.86), as were the cycle threshold values. In comparison with the pediatrician-collected samples, the sensitivity and specificity of the parental collections were respectively 89.3% (95% confidence interval [CI]: 77.8-100%) and 97.7% (95% CI: 95.5-100%), and the positive and negative predictive values were respectively 86.2% (95% CI: 73.7-95.1%) and 98.2% (95% CI: 96.4-100%). The children were significantly more satisfied with the parental collections (median values +/- standard deviation, 1.59 +/- 0.55 vs 3.51 +/- 0.36; p < 0.0001). These findings show that mid-turbinate nasal flocked swabs specifically designed for infants and children can be used by parents without reducing the influenza virus detection rate. Moreover, the direct involvement of parents significantly increases patient acceptance, thus simplifying collection and suggesting that this novel swab design should be considered for epidemiological surveys and vaccine efficacy studies.
    Virology Journal 01/2010; 7:85. · 2.34 Impact Factor