Acute GastroenteritisSAGENCT02245139
Surveillance Study of Acute Gastroenteritis in Hospitalized Children
An observational study of Acute Gastroenteritis and Diarrhea, run by Shaikh Ragheb Harb Hospital.
Trial summary
Acute gastroenteritis is a common cause of hospital admission and health office visits and have a huge burden on the economy of developing countries. The investigators proposed this observational prospective study during summer period in a community and tertiary care hospital in a rural area of Lebanon to investigate… Read more about this study
- Who is it for?
- Ages 1 month to 13 years
- Conditions the study is for
- Acute Gastroenteritis, Diarrhea, Dehydration
- How many people
- 198 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2014to 15 Dec 2014
- How long will I take part?
- 7 Days
- 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 1 month to 13 years
- All sexes
- No healthy volunteers
- Child
Study population: male and female patient from 1 month to 13 YO admitted to pediatric floor with acute gastroenteritis
Who may be able to join
- acute gastroenteritis
Who cannot join
- immunodeficiency
- malnutrition
About this study
Official title: Surveillance Study of Acute Gastroenteritis Etiologies in Hospitalized Children
Acute gastroenteritis is a common cause of hospital admission and health office visits and have a huge burden on the economy of developing countries. The investigators proposed this observational prospective study during summer period in a community and tertiary care hospital in a rural area of Lebanon to investigate the etiologies and age distribution of admitted cases to general pediatric floor from the age of 1 month up to the age of 14 years.
- Conditions
- Acute Gastroenteritis, Diarrhea, Dehydration
- Keywords
- diarrhea, vomiting, fever, abdominal pain, oliguria
- Medical subject headings
- Diarrhea, Dehydration, Vomiting, Fever, Abdominal Pain, Oliguria
What is being measured
The primary outcome is the main question the study is designed to answer.
etiologies
to determine the microbial causes of acute gastroenteritis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study start1 Jul 2014
- Primary completion15 Sep 2014
- Study completion15 Dec 2014
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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 198 participants (actual)
- Target duration
- 7 Days
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
- NCT02245139
- Sponsor's protocol ID
- SRHH12014
- Acronym
- SAGE
- Status last verified
- Apr 2017
- First submitted
- 16 Sep 2014
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance Study of Acute Gastroenteritis Etiologies in Hospitalized Children
- ClinicalTrials.gov ID
- NCT02245139
- Acronym / sponsor ID
- SAGE / SRHH12014
- Conditions
- Acute Gastroenteritis, Diarrhea, Dehydration
- Keywords
- diarrhea, vomiting, fever, abdominal pain, oliguria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Shaikh Ragheb Harb HospitalUniversity, hospital or other
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 15 Sep 2014 (actual)
- Study completion
- 15 Dec 2014 (actual)
- First posted
- 19 Sep 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 hospital admission and health office visits and have a huge burden on the economy of developing countries. The investigators proposed this observational prospective study during summer period in a community and tertiary care hospital in a rural area of Lebanon to investigate the etiologies and age distribution of admitted cases to general pediatric floor from the age of 1 month up to the age of 14 years.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 1 month to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- male and female patient from 1 month to 13 YO admitted to pediatric floor with acute gastroenteritis
Key inclusion criteria (1 listed)
- acute gastroenteritis
Key exclusion criteria (2 listed)
- immunodeficiency
- malnutrition
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
etiologies
Time frame: 1 year
to determine the microbial causes of acute gastroenteritis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Gastroenteritis and Diarrhea, run by Shaikh Ragheb Harb Hospital.
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 2 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: finished, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
etiologies (time frame: 1 year). 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 27 Apr 2017.