Abstract
BackgroundChildren initially hospitalized with severe anaemia in Africa are at high risk of readmission or death within 6 months after discharge. No intervention strategy specifically protects children during the post-discharge period. Recent evidence from Malawi shows that 3 months of post-discharge malaria chemoprevention (PMC) with monthly treatment with artemether-lumefantrine in children with severe malarial anaemia prevented 31% of deaths and readmissions. While a confirmatory multi-centre trial for PMC with dihydroartemisinin-piperaquine is on going in Kenya and Uganda, there is a need to design and evaluate an effective delivery strategy for this promising intervention.MethodsThis is a cluster-randomized trial with 5 arms, each representing a unique PMC delivery strategy. Convalescent children aged less than 5 years and weighing more than 5 kg admitted with severe anaemia and clinically stable are included. All eligible children will receive dihydroartemisinin-piperaquine at 2, 6 and 10 weeks after discharge either: 1) in the community without an SMS reminder; 2) in the community with an SMS reminder; 3) in the community with a community health worker reminder; 4) at the hospital with an SMS reminder; or 5) at the hospital without an SMS reminder. For community-based strategies (1, 2 and 3), mothers will be given all the PMC doses at the time of discharge while for hospital-based strategies (4 and 5) mothers will be required to visit the hospital each month. Each arm will consist of 25 clusters with an average of 3 children per cluster giving approximately 75 children and will be followed up for 15 weeks. The primary outcome measure is uptake of complete courses of PMC drugs.DiscussionThe proposed study will help to identify the most effective, cost-effective, acceptable and feasible strategy for delivering malaria chemoprevention for post-discharge management of severe anaemia in under-five children in the Malawian context. This information is important for policy decision in the quest for new strategies for malaria control in children in similar contexts.Trial registrationClinicalTrials.gov: NCT02721420. Protocol registered on 29 March 2016.The study was not retrospectively registered but there was a delay between date of submission and the date it first became available on the registry.
Highlights
Children initially hospitalized with severe anaemia in Africa are at high risk of readmission or death within 6 months after discharge
The proposed study will help to identify the most effective, cost-effective, acceptable and feasible strategy for delivering malaria chemoprevention for post-discharge management of severe anaemia in under-five children in the Malawian context. This information is important for policy decision in the quest for new strategies for malaria control in children in similar contexts
A case-control study in Malawian children indicated that children aged less than 5 years admitted with severe anaemia were at high risk of dying during the acute phase in-hospital and for several months after discharge from the hospital. 17.2% of children with severe anaemia experienced an all cause mortality compared to 2% of controls without severe anaemia [7]
Summary
Children initially hospitalized with severe anaemia in Africa are at high risk of readmission or death within 6 months after discharge. Recent evidence from Malawi shows that 3 months of post-discharge malaria chemoprevention (PMC) with monthly treatment with artemether-lumefantrine in children with severe malarial anaemia prevented 31% of deaths and readmissions. A case-control study in Malawian children indicated that children aged less than 5 years admitted with severe anaemia were at high risk of dying during the acute phase in-hospital and for several months after discharge from the hospital. High rates of post-discharge morbidity and mortality have been reported in western Kenya and Uganda, where 36.5% of children aged less than 5 years admitted with severe anaemia died after 18 months of follow up [3, 7]
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