Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000145303
Ethics application status
Approved
Date submitted
7/03/2008
Date registered
25/03/2008
Date last updated
25/03/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of guidelines for the management of acute gastroenteritis in outpatient children: a field trial on primary care pediatricians
Scientific title
In children with acute gastroenteritis,
are guidelines (oral rehydration with hypoosmolar solution, early refeeding with full-strength infant formula or normal diet, no medications, no microbiological investigations)
as good or better than non standardized treatment
for a reduction in the duration of diarrhea, improvement of body weight and reduction in costs to society?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute gastroenteritis 2911 0
Condition category
Condition code
Infection 3045 3045 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 2641 0
Not applicable
Comparator / control treatment
Seventy-five randomly selected primary care pediatricians not trained in the guidelines. They will not be specifically exposed to the guidelines and therefore will manage the patients as they would do normally. Pediatricians will be informed that they will be enrolled in an observational study on the features of diarrhea and its treatment. 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.
Control group
Active

Outcomes
Primary outcome [1] 3928 0
Total duration of diarrhea (hours)
Timepoint [1] 3928 0
At 5, 7 and 15 days after the first visit
Secondary outcome [1] 6606 0
Changes in body weight between the first visit and the control visit;
Timepoint [1] 6606 0
At 5, 7 and 15 days after the first visit
Secondary outcome [2] 6607 0
Costs of active medical prescriptions and microbiological examinations, in addition to oral rehydration solutions and acetaminophen. Costs will be assessed on standard rates as follows: antibiotics or other drugs= 10 EUR; lactose-free formula = 10 EUR; protein hydrolysate formula= 20 EUR; microbiological examinations = 25 EUR. Total average costs will be calculated as the sum of the total costs for all medical prescriptions divided by the number of children in each group.
Timepoint [2] 6607 0
At 15 days

Eligibility
Key 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.
Minimum age
1 Months
Maximum age
36 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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,

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/01/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment outside Australia
Country [1] 815 0
Italy
State/province [1] 815 0

Funding & Sponsors
Funding source category [1] 3164 0
University
Name [1] 3164 0
University of Naples Federico II Department of Pediatrics
Country [1] 3164 0
Italy
Primary sponsor type
University
Name
University of Naples Federico II Department of Pediatrics
Address
Via Sergio Pansini 5, 80131 Naples
Country
Italy
Secondary sponsor category [1] 2836 0
None
Name [1] 2836 0
Address [1] 2836 0
Country [1] 2836 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5141 0
Ethics Committee Of University of Naples "Federico II"
Ethics committee address [1] 5141 0
Via Sergio Pansini 5, 80131 Naples
Ethics committee country [1] 5141 0
Italy
Date submitted for ethics approval [1] 5141 0
19/02/2008
Approval date [1] 5141 0
05/03/2008
Ethics approval number [1] 5141 0
35/08

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28427 0
Address 28427 0
Country 28427 0
Phone 28427 0
Fax 28427 0
Email 28427 0
Contact person for public queries
Name 11584 0
Alfredo Guarino
Address 11584 0
University of Naples "Federico II",
Department of Pediatrics,
Via Sergio Pansini 5, 80131 Naples
Country 11584 0
Italy
Phone 11584 0
00 39 0817464232
Fax 11584 0
00 39 0817464232
Email 11584 0
[email protected]
Contact person for scientific queries
Name 2512 0
Alfredo Guarino
Address 2512 0
University of Naples "Federico II",
Department of Pediatrics,
Via Sergio Pansini 5, 80131 Naples
Country 2512 0
Italy
Phone 2512 0
00 39 0817464232
Fax 2512 0
00 39 0817464232
Email 2512 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.