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Improved Management and in-Hospital Mortality

NCT ID: NCT00465777

Last Updated: 2007-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

950 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2006-02-28

Brief Summary

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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

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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.

Conditions

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Mortality Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Interventions

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Guideline adherence and financial incentive

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Hospitalization due to malaria
* Non per os

Exclusion Criteria

* Consent from parent/caretaker declined
Minimum Eligible Age

3 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Statens Serum Institut

OTHER

Sponsor Role collaborator

World Health Organization

OTHER

Sponsor Role collaborator

Bandim Health Project

OTHER

Sponsor Role lead

Principal Investigators

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Peter Aaby, DMSc

Role: STUDY_CHAIR

Bandim Health Project

Locations

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Bandim Health Project

Bissau, Bissau Region, Guinea-Bissau

Site Status

Countries

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Guinea-Bissau

References

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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.

Reference Type DERIVED
PMID: 17954513 (View on PubMed)

Other Identifiers

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PED-MTV-2004

Identifier Type: -

Identifier Source: org_study_id