Evaluation of the Basic Assessment of Severity of Illness... | NCT01068574

Studies
Evaluation of the Basic Assessment of Severity of Illness in Children (BASIC) Scale

NCT01068574

Sponsor

Brigham and Women's Hospital

Status

Unknown status

Last Update Posted

Aug 3, 2010Estimated

Enrollment

2,500Estimated

Phase

Not provided

Conditions

Acute Illness

Interventions

BASIC Score (Observational)

Countries

Rwanda

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Sep 2010Estimated

Completion Date

Sep 2010Estimated

First Submitted Date

Feb 12, 2010

First Submission Date that Met QC Criteria

Feb 12, 2010

First Posted Date

Feb 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2010

Last Update Posted Date

Aug 3, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Brigham and Women's HospitalOTHER

Collaborators

Name	Class
Partners in Health	OTHER
Thrasher Research Fund	OTHER
Ministry of Health, Rwanda	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Observational Cohort			Other: BASIC Score (Observational)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BASIC Score (Observational)	Other	The BASIC Score will be assessed by a study staff, but there are no interventions.	Single Observational Cohort

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Months

Maximum Age

5 Years

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Peter Drobac, MD	Contact	857-776-7114		pdrobac@partners.org

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Butaro Health Centre	Recruiting	Butaro	Northern Province		Rwanda