Salvatore Renna

Effectiveness and safety of the A-H1N1 vaccine in children: A hospital-based case - Control study

Objective To verify whether vaccination against the A-H1N1 virus in the paediatric population was effective in preventing the occurrence of influenza-like illness (ILI) or was associated with adverse events of special interest. Design, setting and patients A case–control analysis was performed as part of surveillance of children hospitalised through the emergency departments of eight paediatric hospitals/wards for ILI, neurological disorders, non-infectious muco-cutaneous diseases and vasculitis, thrombocytopaenia and gastroduodenal lesions. Results Among 736 children enrolled from November 2009 to August 2010, only 25 had been vaccinated with the pandemic vaccine. Out of 268 children admitted for a diagnosis compatible with the adverse events of special interest, six had received the A-H1N1 vaccine, although none of the adverse events occurred within the predefined risk windows. Only 35 children out of 244 admitted with a diagnosis of ILI underwent laboratory testing: 11 were positive and 24 negative for the A-H1N1 virus. None of the A-H1N1 positive children had received the pandemic vaccine. The OR of ILI associated with any influenza vaccination was 0.9 (95% CI 0.1 to 5.5). Conclusions The study provides additional information on the benefit–risk profile of the pandemic vaccine. No sign of risk associated with the influenza A-H1N1 vaccine used in Italy was found, although several limitations were observed: in Italy, pandemic vaccination coverage was low, the epidemic was almost over by mid December 2009 and the A-H1N1 laboratory test was performed only during the epidemic phase (in <10% of children). This study supports the importance of the existing network of hospitals for the evaluation of signals relevant to new vaccines and drugs.

Oral ondansetron versus domperidone for symptomatic treatment of vomiting during acute gastroenteritis in children: multicentre randomized controlled trial

BackgroundVomiting in children with acute gastroenteritis (AG) is not only a direct cause of fluid loss but it is also a major factor of failure of oral rehydration therapy (ORT). Physicians who provide care to paediatric patients in the emergency department (ED) usually prescribe intravenous fluid therapy (IVT) for mild or moderate dehydration when vomiting is the major symptom. Thus, effective symptomatic treatment of vomiting would lead to an important reduction in the use of IVT and, consequently, of the duration of hospital stay and of frequency of hospital admission. Available evidence on symptomatic treatment of vomiting shows the efficacy of the most recently registered molecule (ondansetron) but a proper evaluation of antiemetics drugs largely used in clinical practice, such as domperidone, is lacking.ObjectivesTo compare the efficacy of ondansetron and domperidone for the symptomatic treatment of vomiting in children with AG who have failed ORT.Methods/DesignMulticentre, double-blind randomized controlled trial conducted in paediatric EDs. Children aged from 1 to 6 years who vomiting, with a presumptive clinical diagnosis of AG, and without severe dehydration will be included. After the failure of a initial ORS administration in ED, eligible children will be randomized to receive: 1) ondansetron syrup (0,15 mg/Kg of body weight); 2) domperidone syrup (0,5 mg/Kg of body weight); 3) placebo. The main study outcome will be the percentage of patients needing nasogastric or IVT after symptomatic oral treatment failure, defined as vomiting or fluid refusal after a second attempt of ORT. Data relative to study outcomes will be collected at 30 minute intervals for a minimum of 6 hours. A telephone follow up call will be made 48 hours after discharge. A total number of 540 children (i.e. 180 patients in each arm) will be enrolled.DiscussionThe trial results would provide evidence on the efficacy of domperidone, which is largely used in clinical practice despite the lack of proper evaluation and a controversial safety profile, as compared to ondansetron, which is not yet authorized in Italy despite evidence supporting its efficacy in treating vomiting. The trial results would contribute to a reduction in the use of IVT and, consequently, in hospital admissions in children with AG. The design of this RCT, which closely reflect current clinical practice in EDs, will allow immediate transferability of results.Trial RegistrationClinicalTrials.gov: NCT01257672

Vaccine effectiveness against severe laboratory-confirmed influenza in children: results of two consecutive seasons in Italy

OBJECTIVE To evaluate the effectiveness of seasonal influenza vaccine in preventing Emergency Department (ED) visits and hospitalisations for influenza like illness (ILI) in children. METHODS We conducted a test negative case-control study during the 2011-2012 and 2012-2013 influenza seasons. Eleven paediatric hospital/wards in seven Italian regions participated in the study. Consecutive children visiting the ED with an ILI, as diagnosed by the doctor according to the European Centre for Disease Control case definition, were eligible for the study. Data were collected from trained pharmacists/physicians by interviewing parents during the ED visit (or hospital admission) of their children. An influenza microbiological test (RT-PCR) was carried out in all children. RESULTS Seven-hundred and four children, from 6 months to 16 years of age, were enrolled: 262 children tested positive for one of the influenza viruses (cases) and 442 tested negative (controls). Cases were older than controls (median age 46 vs. 29 months), though with a similar prevalence of chronic conditions. Only 25 children (4%) were vaccinated in the study period. The overall age-adjusted vaccine effectiveness (VE) was 38% (95% confidence interval -52% to 75%). A higher VE was estimated for hospitalised children (53%; 95% confidence interval -45% to 85%). DISCUSSION This study supports the effectiveness of the seasonal influenza vaccine in preventing visits to the EDs and hospitalisations for ILI in children, although the estimates were not statistically significant and with wide confidence intervals. Future systematic reviews of available data will provide more robust evidence for recommending influenza vaccination in children.

Acute post-infectious cerebellar ataxia due to co-infection of human herpesvirus-6 and adenovirus mimicking myositis

Acute cerebellar ataxia (ACA) is a relatively common neurological disease in children. Most common types of ACA are acute post-infectious (APCA) and acute disseminated encephalomyelitis (ADEM). Less common but important causes include opsoclonus-myoclonus syndrome (OMS) and acute cerebellitis. Cerebellar neoplasms and acute hydrocephalus are additional causes of paediatric ataxia. APCA is the most common cause of ACA in children, comprising about 30-50% of total cases. This is a report about an immunocompetent 4-yrs-old male affected by APCA, due to co-infection by human herpesvirus-6 (HHV-6) and adenovirus, with symptoms mimicking myositis.

A surveillance-oriented medical record as a source of data for both drug and quality of care surveillance

The medical record for hospitalized patients has been modified in order to orient it towards two types of surveillance: adverse drug reactions (ADRs) and the quality of medical care. The modification consists of an adaptation of the progress notes; the transfer of the information to a special database is facilitated by the use of a simple system of codes that identify and correlate the items necessary for surveillance purposes. During the 6 months of observation of the 1103 pediatric patients included in the study, 35 clinically important suspected ADRs were noted by physicians. For the quality of medical care surveillance, all drug prescriptions were evaluated and areas in which to intervene in order to improve the appropriateness of prescriptions were identified. Quality surveillance was also extended to the monitoring of ‘unexplained’ adverse events for which no particular cause was attributable. We consider it advantageous to carry out these two types of surveillance simultaneously because they require many common items of information. The use of an oriented medical record as a source of data makes it possible to integrate surveillance with everyday ward activities. Copyright

Oral ondansetron versus domperidone for acute gastroenteritis in pediatric emergency departments: Multicenter double blind randomized controlled trial

The use of antiemetics for vomiting in acute gastroenteritis in children is still a matter of debate. We conducted a double-blind randomized trial to evaluate whether a single oral dose of ondansetron vs domperidone or placebo improves outcomes in children with gastroenteritis. After failure of initial oral rehydration administration, children aged 1–6 years admitted for gastroenteritis to the pediatric emergency departments of 15 hospitals in Italy were randomized to receive one oral dose of ondansetron (0.15 mg/kg) or domperidone (0.5 mg/kg) or placebo. The primary outcome was the percentage of children receiving nasogastric or intravenous rehydration. A p value of 0.014 was used to indicate statistical significance (and 98.6% CI were calculated) as a result of having carried out two interim analyses. 1,313 children were eligible for the first attempt with oral rehydration solution, which was successful for 832 (63.4%); 356 underwent randomization (the parents of 125 children did not give consent): 118 to placebo, 119 to domperidone, and 119 to ondansetron. Fourteen (11.8%) needed intravenous rehydration in the ondansetron group vs 30 (25.2%) and 34 (28.8%) in the domperidone and placebo groups, respectively. Ondansetron reduced the risk of intravenous rehydration by over 50%, both vs placebo (RR 0.41, 98.6% CI 0.20–0.83) and domperidone (RR 0.47, 98.6% CI 0.23–0.97). No differences for adverse events were seen among groups. In a context of emergency care, 6 out of 10 children aged 1–6 years with vomiting due to gastroenteritis and without severe dehydration can be managed effectively with administration of oral rehydration solution alone. In children who fail oral rehydration, a single oral dose of ondansetron reduces the need for intravenous rehydration and the percentage of children who continue to vomit, thereby facilitating the success of oral rehydration. Domperidone was not effective for the symptomatic treatment of vomiting during acute gastroenteritis.

Methodological and motivational factors affecting the surveillance of adverse events in hospitalized patients.

This is a critical review of the methodological and motivational aspects of two experiences of adverse event (AE) monitoring using a surveillance diary incorporated into the progress notes of medical records. Methodological aspects of the study were that (1) AE monitoring was to become an everyday activity of ward physicians; (2) the physicians were to express their opinions concerning the causality of each AE, which was to allow the systematic detection of adverse drug reactions and unexplained AEs; (3) the surveillance diary was to include all AEs and all prescriptions, thus allowing prescription-event monitoring; (4) the time trends of unexplained AEs were to be monitored using control cards. The experiences were discontinued because the necessary investments were attributed to other competing priorities. It follows that it is essential to develop an awareness that AE surveillance requires continuous involvement insofar as it is an essential element of quality of care.

Listeria Meningitis in an Immunocompetent Child: A Case Report

Listeria monocytogenes is a facultative anerobic, gram-positive bacillus that is isolated from the soil, vegetables, and wild or domestic animals. Listeria infection is usually found in the older adults, immunocompromised patients, pregnant women, and newborns, whereas it is rare in healthy infants and children. Listeria monocytogenes may cause meningitis, meningoencephalitis, brain abscess, pyogenic arthritis, osteomyelitis, and liver abscess in children. The course of meningoencephalitis by Listeria is often severe and even fatal. Complications such as acute hydrocephalus, brain abscess, and spine abscess can develop, and the mortality associated with listeriosis is significantly high. We present a case of a previously healthy 7-year-old boy who developed Listeria monocytogenes meningitis.

What Is the Best Initial Empirical Treatment of Suspected Sepsis in a Newborn Readmitted Soon after Discharge Home in an Era of Increased Resistance to Antibiotics? A Report of Two Cases.

Background Colonization/infection by antibiotic-resistant bacteria is becoming a major threat to health care systems. Case report Two septic neonates were readmitted in our hospital few days after hospital discharge. In both of them, microbiological workup revealed an infection caused by multiresistant pathogens. Noteworthy, one baby had received intensive care management for 4 weeks, whereas the other had been vaginally delivered and sent home on his second day of life. Conclusion These cases suggest that in countries and/or hospital with high prevalence of colonization/infection by resistant pathogens in nurseries, neonatal intensive care units, and obstetric wards, the choice of initial therapy of suspected sepsis in a neonate readmitted from home soon after discharge should take into account the possibility of an infection due to a multiresistant pathogen.

Disk battery ingestion: high clinic risk

Over the last ten years disk battery (DB) ingestion have been increasing in children with serious consequences due to the diffusion of lithium battery (LB) that may cause catastrophic damages when lodged in the esophagus. The severity of injury depends on cell type, size, voltage, location and time of contact with the mucosa because electrical generation of hydroxide ions at the negative pole, leakage of alkaline content in stomach and mechanical pressure. Because LB are larger (> 20 mm), flatter and have an higher voltage (3V) than alkaline DB (1.5 V) in small children their ingestion increases the risk of esophageal lodgment and tissue damage in just two hours [1,2]. DB ingestion is not witnessed in 92% of fatal outcomes and 56% of major complications; 36% of patients with esophageal lodgment are initially asymptomatic [3]. Clinical presentation can be variable from absence of symptoms to drooling, dysphagia, vomiting, chest pain, or dyspnea, fever, abdominal pain, irritability and feeding refusal and sudden fatal exsanguination for a fistula between esophagus and mediastinic vessels [3,4]. Other complications are trachea-esophageal fistula, laryngeal/esophageal stenosis, esophageal perforation, vocal cord paralysis, tracheomalacia, aspiration pmeumonia, empyema, lung abscess, and spondylodiscitis [2]. Complications can be delayed, as the mucosal lesions may worsen also after DB removal. Plain chest and abdomen X-ray have a primary role to address the diagnosis and locate DB, revealed by the double ring or “halo” effect. A “sentinel bleed”, isolated hematemesis/melena occurring hours or days before a fatal hemorrage, is another atypical presenting symptom [4]. Exsanguination can occur with the DB still in the GI tract or until 28 days after its removal [1,2]. We propose a new protocol for DB ingestion management in children and stress the necessity of prevention with public awareness campaigns promoted by scientific Societies and preventive information addressed to parents and caregivers [3]. Figure 1 Algorithms for the management of ingested Disk Batteries in children (Lithium Batteries or Alkalike Batteries). 1. The follow-up, above all in case of esophageal lesion, should monitor possible late onset esophageal perforation or vessel fistula. 2. Consider ...