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Improved Management and in-Hospital Mortality (MTV)

Primary Purpose

Mortality, Malaria

Status

Completed

Phase

Not Applicable

Locations

Guinea-Bissau

Study Type

Interventional

Intervention

Guideline adherence and financial incentive

About this trial

This is an interventional health services research trial for Mortality focused on measuring malaria, mortality, hospital, incentive, personnel, paediatric

Eligibility Criteria

3 Months - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Hospitalization due to malaria
Non per os

Exclusion Criteria:

Consent from parent/caretaker declined

Sites / Locations

Bandim Health Project

Outcomes

Primary Outcome Measures

In-hospital case-fatality

Secondary Outcome Measures

Cumulative post-discharge mortality on day 28 and length of hospitalisation

Full Information

NCT ID

NCT00465777

First Posted

April 23, 2007

Last Updated

April 23, 2007

Sponsor

Bandim Health Project

Collaborators

Statens Serum Institut, World Health Organization

1. Study Identification

Unique Protocol Identification Number

NCT00465777

Brief Title

Improved Management and in-Hospital Mortality

Acronym

MTV

Official Title

Reduced in-Hospital Mortality After Improved Management of Patients Hospitalised With Malaria. A Randomised Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2007

Overall Recruitment Status

Completed

Study Start Date

December 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Bandim Health Project

Collaborators

Statens Serum Institut, World Health Organization

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The study intend to evaluate whether the use of standardised malaria case management protocol plus financial incentives added to the availability of free drugs reduce the case-fatality at the paediatric ward.

Detailed Description

Mortality at the national paediatric ward in Guinea-Bissau is very high. During a civil war in 1998/1999 the hospital case fatality (CF) decreased by more than 40%, increasing again after the the war. This was attributed to the available free drugs from the humanitarian aid and food incentives to the personnel. Free emergency kits for treatment of severe malaria was introduced, however the CF did not decline. Therefore, the ward was split into two groups of rooms: intervention and control. All the staff of the ward was trained in the use of a standardised guideline for treatment of severe malaria and randomly assigned to one of the groups. All children hospitalised for malaria received the drug emergency kits. The only difference in the intervention group were the small financial incentives and supervision for strict adherence to the guidelines procedures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mortality, Malaria

Keywords

malaria, mortality, hospital, incentive, personnel, paediatric

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

950 (false)

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

Guideline adherence and financial incentive

Primary Outcome Measure Information:

Title

In-hospital case-fatality

Secondary Outcome Measure Information:

Title

Cumulative post-discharge mortality on day 28 and length of hospitalisation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Months

Maximum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Hospitalization due to malaria Non per os Exclusion Criteria: Consent from parent/caretaker declined

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Aaby, DMSc

Organizational Affiliation

Bandim Health Project

Official's Role

Study Chair

Facility Information:

Facility Name

Bandim Health Project

City

Bissau

ZIP/Postal Code

1004

Country

Guinea-Bissau

12. IPD Sharing Statement

Citations:

PubMed Identifier

17954513

Citation

Biai S, Rodrigues A, Gomes M, Ribeiro I, Sodemann M, Alves F, Aaby P. Reduced in-hospital mortality after improved management of children under 5 years admitted to hospital with malaria: randomised trial. BMJ. 2007 Oct 27;335(7625):862. doi: 10.1136/bmj.39345.467813.80. Epub 2007 Oct 22.

Results Reference

derived

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Improved Management and in-Hospital Mortality

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