Nosocomial Infection
Conditions
Keywords
LGG, Probiotics, nosocomial infection prevention, pediatrics
Brief summary
Nosocomial infections are infections that occur from the time of 'entry in the hospital up to 48h after discharge. In most developed countries, the incidence of nosocomial infections in children is between 5% and 44% with the predominance of respiratory infections and gastrointestinal infections. Nosocomial infections prolong the time of hospital stay, reduce the effectiveness of treatment, significantly increasing hospital costs. Current measures for prevention of nosocomial infections in pediatrics, such as vaccinations and compliance with sanitary regulations, are not fully effective. Therefore it is necessary a deepening of the possible methods of prevention, between which has been already tested the use of probiotics such as Lactobacillus GG. A recent RCCT, which provided for the administration of LGG against placebo, noted a significant reduction in the risk of gastrointestinal infections and respiratory infections in hospitalized children treated with LGG, compared with patients who received placebo. There are also evidence which demonstrate a potential role zinc in reducing the incidence of respiratory infections is that bowel. We thought, therefore, to perform a multicenter randomized controlled trial with the aim to evaluate the role of a complex containing LGG, vitamins and zinc in the prevention of nosocomial gastrointestinal and respiratory tract infections in pediatric wards.
Interventions
DIETARY_SUPPLEMENTLactobacillus Rhamnosus GG
1 vials q12 for 15 days
DIETARY_SUPPLEMENTPLACEBO
1 vials q12 for 15 days
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Months to 5 Years
Healthy volunteers
No
Inclusion criteria
* Males and females between the ages of 3 months and 5 years * Children admitted to a pediatric ward
Exclusion criteria
* Children with chronic diseases of the respiratory , gastrointestinal , renal system; * Children with malformations of the cardiovascular system ; * Children with immune deficiencies ; * Infants born preterm ( gestational age \< 37 weeks ) ; * Children with congenital metabolic diseases ; * Children Who received probiotics before enrollment ( up to 7 days before hospitalization)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study the incidence of nosocomial gastrointestinal infection | After 15 days of treatment |
| Study the incidence of nosocomial URTI | After 15 days of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Days of hospitalization | After 3 months from the enrollment |
| The incidence of gastrointestinal and respiratory infection during the 3 month follow-up period | After 3 months from the treatment |
Countries
Italy
Outcome results
None listed