Acute GastroenteritisSAGENCT02177799
Surveillance Study of Acute Gastroenteritis in Hospitalized Children in Rural Area in Lebanon
An observational study of Acute Gastroenteritis and Diarrhea, run by Shaikh Ragheb Harb Hospital at 1 site in Lebanon.
Trial summary
Acute gastroenteritis is a common cause of hospitalization in children with significant socioeconomic burden on the health community, we will follow in this observational and analytical study the admitted cases of acute gastroenteritis to the pediatric floor at the Sheikh Ragheb Harb Hospital over a period of summer… Read more about this study
- Who is it for?
- Ages 2 months to 10 years
- Conditions the study is for
- Acute Gastroenteritis, Diarrhea, Rotavirus
- How many people
- 150 participants
- Where
- 1 siteLebanon
- Study dates
- Jul 2014to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Children male and female from 2 months to 10 year old
Who may be able to join
- children with acute gastroenteritis admitted to the pediatric floor
Who cannot join
- chronic diarrhea or Immunodeficiency
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
Sheikh Ragheb Harb Hospital
Nabatieh, Toul
Hadi Fakih, MD, 009613912686, hadifakihdmd75@hotmail.com
About this study
Official title: Surveillance Study of Acute Gastroenteritis in Hospitalized Children
Acute gastroenteritis is a common cause of hospitalization in children with significant socioeconomic burden on the health community, we will follow in this observational and analytical study the admitted cases of acute gastroenteritis to the pediatric floor at the Sheikh Ragheb Harb Hospital over a period of summer time to determine the causes, etiologies and epidemiology of Age in a community hospital.
Read the detailed description
In this survey of hospitalized cases of acute gastroenteritis, children between two months and up to ten years old are included except for known cases of chronic diarrhea, malnutrition or immunodeficiency, data collected include clinical signs and symptoms, epidemiologic information and laboratory data during the hospital stay, also hospital treatment will be reviewed to determine the therapeutic options available in our country and its convenience with the disease and clinical conditions.
- Conditions
- Acute Gastroenteritis, Diarrhea, Rotavirus
- Keywords
- Gastroenteritis, Hospitalized, Children
- Medical subject headings
- Diarrhea, Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| gastroenteritis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age distribution
Measured: one year after completing data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute GastroenteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaikh Ragheb Harb Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HADI FAKIH, MD, Shaikh Ragheb Harb Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177799
- Sponsor's protocol ID
- RHH12014
- Acronym
- SAGE
- Status last verified
- Jun 2014
- First submitted
- 25 Jun 2014
- Last updated
- 1 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance Study of Acute Gastroenteritis in Hospitalized Children
- ClinicalTrials.gov ID
- NCT02177799
- Acronym / sponsor ID
- SAGE / RHH12014
- Conditions
- Acute Gastroenteritis, Diarrhea, Rotavirus
- Keywords
- Gastroenteritis, Hospitalized, Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shaikh Ragheb Harb HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Oct 2014 (estimated)
- First posted
- 30 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute gastroenteritis is a common cause of hospitalization in children with significant socioeconomic burden on the health community, we will follow in this observational and analytical study the admitted cases of acute gastroenteritis to the pediatric floor at the Sheikh Ragheb Harb Hospital over a period of summer time to determine the causes, etiologies and epidemiology of Age in a community hospital.
Detailed description
In this survey of hospitalized cases of acute gastroenteritis, children between two months and up to ten years old are included except for known cases of chronic diarrhea, malnutrition or immunodeficiency, data collected include clinical signs and symptoms, epidemiologic information and laboratory data during the hospital stay, also hospital treatment will be reviewed to determine the therapeutic options available in our country and its convenience with the disease and clinical conditions.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gastroenteritis | – | – |
Who may qualify
- Ages
- 2 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children male and female from 2 months to 10 year old
Key inclusion criteria (1 listed)
- children with acute gastroenteritis admitted to the pediatric floor
Key exclusion criteria (1 listed)
- chronic diarrhea or Immunodeficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Age distribution
Time frame: one year after completing data collection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Gastroenteritis and Diarrhea, run by Shaikh Ragheb Harb Hospital at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HADI FAKIH, MD (009613912686, hadifakihdmd75@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age distribution (time frame: one year after completing data collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2014.