Acute IllnessNCT01068574
Evaluation of the Basic Assessment of Severity of Illness in Children (BASIC) Scale
An observational study of Acute Illness, run by Brigham and Women's Hospital at 1 site in Rwanda.
Trial summary
The purpose of this study is to assess whether the BASIC Scale--a simple, non-invasive clinical triage protocol--predicts severe illness, hospitalization or death among children under age five presenting for acute care in a rural African health center. Read more about this study
- Who is it for?
- Ages 2 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Illness
- What is being tested?
- BASIC Score (Observational)
- How many people
- 2,500 participants
- Where
- 1 siteRwanda
- Study dates
- Jan 2010to Sep 2010
- 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 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged two months to five years presenting to a rural health center in Rwanda.
Who may be able to join
- Child aged two months to five years presenting routine or urgent care in an ambulatory facility
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Rwanda1 site, 1 recruiting
- Recruiting
Butaro Health Centre
Butaro, Northern Province
Peter Drobac, MD, 857-776-7114, pdrobac@partners.org
About this study
Official title: Evaluation of the BASIC Scale (Basic Assessment of Severity of Illness in Children): A Simple Triage Tool for Resource-limited Settings
The purpose of this study is to assess whether the BASIC Scale--a simple, non-invasive clinical triage protocol--predicts severe illness, hospitalization or death among children under age five presenting for acute care in a rural African health center.
- Conditions
- Acute Illness
- Being tested
- BASIC Score (Observational)
- Keywords
- Acute illnesses in children under five
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BASIC Score (Observational)Other
The BASIC Score will be assessed by a study staff, but there are no interventions.
| Study group | Role | What they receive |
|---|---|---|
| Single Observational Cohort | Not described Receives: Other: BASIC Score (Observational) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute IllnessStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Partners in Health, Thrasher Research Fund, Ministry of Health, Rwanda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068574
- Sponsor's protocol ID
- 2009P002546
- Status last verified
- Aug 2010
- First submitted
- 12 Feb 2010
- Last updated
- 3 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the BASIC Scale (Basic Assessment of Severity of Illness in Children): A Simple Triage Tool for Resource-limited Settings
- ClinicalTrials.gov ID
- NCT01068574
- Acronym / sponsor ID
- 2009P002546
- Conditions
- Acute Illness
- Keywords
- Acute illnesses in children under five
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Partners in Health, Thrasher Research Fund, Ministry of Health, Rwanda
- Study start
- Jan 2010
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 15 Feb 2010 (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.
The purpose of this study is to assess whether the BASIC Scale--a simple, non-invasive clinical triage protocol--predicts severe illness, hospitalization or death among children under age five presenting for acute care in a rural African health center.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Observational Cohort | – | Other: BASIC Score (Observational) |
Who may qualify
- Ages
- 2 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged two months to five years presenting to a rural health center in Rwanda.
Key inclusion criteria (1 listed)
- Child aged two months to five years presenting routine or urgent care in an ambulatory facility
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BASIC Score (Observational)The BASIC Score will be assessed by a study staff, but there are no interventions. | Other | Single Observational Cohort |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2010.
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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 Illness, run by Brigham and Women's Hospital at 1 site in Rwanda.
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 3 Aug 2010. 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 Rwanda. 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 Peter Drobac, MD (857-776-7114, pdrobac@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 3 Aug 2010.