NCT01068574

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 12, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

August 3, 2010

Status Verified

August 1, 2010

Enrollment Period

8 months

First QC Date

February 12, 2010

Last Update Submit

August 2, 2010

Conditions

Keywords

Acute illnesses in children under five

Study Arms (1)

Single Observational Cohort

Other: BASIC Score (Observational)

Interventions

The BASIC Score will be assessed by a study staff, but there are no interventions.

Single Observational Cohort

Eligibility Criteria

Age2 Months - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children aged two months to five years presenting to a rural health center in Rwanda.

You may qualify if:

  • Child aged two months to five years presenting routine or urgent care in an ambulatory facility

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butaro Health Centre

Butaro, Northern Province, Rwanda

RECRUITING

Central Study Contacts

Peter Drobac, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 12, 2010

First Posted

February 15, 2010

Study Start

January 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

August 3, 2010

Record last verified: 2010-08

Locations