None listed
Conditions
Brief summary
Although there are several guidelines for the management of acute gastroenteritis in children, it is not known whether guideline application actually results in a better outcome of the disease which is a measure of guideline efficacy. Several studies have described the effects of single interventions such as drugs, oral rehydration solution compositions and feeding regimens but nothing is known about a global management strategy. In this national case-controlled field trial, we want to evaluate the management and outcome of children with acute gastroenteritis managed by pediatricians exposed or not to specific guidelines. We believe that the application of guidelines results in an improved outcome of the disease and in a reduction in costs to society.
Interventions
Seventy-five randomly selected primary care pediatricians will be instructed to comply with guidelines for the management of acute gastroenteritis. Eighteen regional coordinators will conduct a 2-hour course consisting in a 30-minute presentation of the guidelines and a 30-minute questions' session, followed by presentation and discussion of the study protocol for an additional hour. The pediatricians will be instructed to comply with 5 major recommendations in the guidelines: 1. rapid oral rehy
Seventy-five randomly selected primary care pediatricians will be instructed to comply with guidelines for the management of acute gastroenteritis. Eighteen regional coordinators will conduct a 2-hour course consisting in a 30-minute presentation of the guidelines and a 30-minute questions' session, followed by presentation and discussion of the study protocol for an additional hour. The pediatricians will be instructed to comply with 5 major recommendations in the guidelines: 1. rapid oral rehydration for 3-4 hours with hypoosmolar solution (Na 60 mmol/L); 2. rapid refeeding, after 4 hours of rehydration, with the child's normal diet, including solids, full-strength milk or formula, without any restriction on lactose intake; 3. not to use beverages as cola, fruit juicers, tea or other drinks; 4. not to request microbiological investigations; 5.no medications. Pediatricians will ask the children's parents to fill in a specific form with day-by-day information about the number of stools per day and their consistency, defined as "liquid", "semi-liquid" or "loose" together with the type of rehydration, feeding, medication and microbiological test administered to the child. The forms will be returned upon the control visit, 5, 7 and 15 days after the enrolment visit. Informed consent will be obtained from the parents of enrolled children.
Sponsors
University of Naples Federico II Department of Pediatrics
Eligibility
Sex/Gender
All
Age
1 Months to 36 Months
Healthy volunteers
No
Inclusion criteria
Each pediatrician will enrol 10 children with acute onset diarrhea in the 12 months of the study (i.e., the first child seen each month until a total of 10 children are enrolled). Onset of diarrhea will be defined as the time of the first loose or liquid stool output. Acute diarrhea will be defined as > 3 loose or liquid stools per day. Dehydration will be estimated with a scoring system.
Exclusion criteria
Assumptions of antibiotics or other drugs in the previous 2 weeks, signs of acute systemic illness, the onset of diarrhea more than 36 hours before enrolment and any chronic disease or immunosuppressive condition,
Outcome results
None listed