An advanced cookstove intervention to prevent pneumonia in children under 5 years old in Malawi: a cluster randomised controlled trial. (360G-Wellcome-100069_Z_12_Z)

Trial type: Prevention. Design: Village-level cluster randomised controlled trial with two arms of equal size. Interventions: Experimental - The Philips fan-assisted stove with user training (replacing open fires). Control - Continuation of traditional cooking methods (open fire). Randomisation: By matched pairs of villages using computer-based system stratified by district to trial arms in a 1:1 ratio. Target population: Children up to 4.5 years old in Malawi allowing for a minimum of 6 months data collection before a child's 5th birthday. The trial will be broadly inclusive. HIV infection will not be an exclusion criterion. Duration of treatment period and follow-up: 24 months from randomisation. Primary outcome measure: Incidence of pneumonia in children under 5 years of age diagnosed by blinded physicians or medical officers using the WHO Integrated Management of Childhood Illness (IMCI) pneumonia assessment protocol. Economic, social, qualitative measures: Analyses will be carried out to explore factors that may be relevant for scale up of the intervention in the future. Sample size and potential power of the trial: Randomisation will be at the village level with an expected average number of children per village of 85 (77 after allowing for 10% loss to follow up). The between cluster CV has been set at the conservatively high level of 0.10. The latest data from Malawi suggest that around 9% of control group children will develop pneumonia severe enough to require treatment at a healthcare facility every year. We are using a highly conservative estimate of 5% (allowing for impact of pneumococcal vaccine). A sample of 59 villages per group will give 80% power to detect a 20% reduction in risk in the intervention group from 5% to 4% (a=0.05). Consumer involvement: Villagers, local stove producers and community leaders in Blantyre and Balaka districts have been involved with the development of this trial proposal through community engagement meetings.

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Grant Details

Amount Awarded 523282
Applicant Surname Gordon
Approval Committee Joint Global Health Trials Committee
Award Date 2012-06-06T00:00:00+00:00
Financial Year 2011/12
Grant Programme: Title Joint Global Health Trials Award
Internal ID 100069/Z/12/Z
Lead Applicant Prof Stephen Gordon
Partnership Name Joint Global Health Trials
Partnership Value 523282
Planned Dates: End Date 2017-05-31T00:00:00+00:00
Planned Dates: Start Date 2012-12-01T00:00:00+00:00
Recipient Org: Country United Kingdom
Region North West