Management of fast breathing pneumonia in young infants aged 7 to 59 days by community level health workers: protocol for a multi-centre cluster randomized controlled trial

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dc.contributor.authorNisar, Yasir Binen_US
dc.date.accessioned2020-05-06T08:34:22Z
dc.date.available2020-05-06T08:34:22Z
dc.date.issued2020-04
dc.description.abstractBackground:WHO does not recommend community-level health workers (CLHWs) using integrated community case management (iCCM) to treat 7-59 days old infants with fast breathing with oral amoxicillin, whereas World Health Organization (WHO)integrated management of childhood illness (IMCI) recommends it. We want to collect evidence to help harmonization of both protocols.Methods:A cluster, randomized, open-label trial will be conducted in Africa and Asia (Ethiopia, Malawi, Bangladesh and India) using a common protocol with the same study design, inclusion criteria, intervention, comparison, and outcomes to contribute to the overall sample size. This trial will also identify hypoxaemia in young infants with fast breathing. CLHWs will assess infants for fast breathing, which will be confirmed by a study supervisor. Enrolled infants in the intervention clusters will be treated with oral amoxicillin, whereas in the control clusters they will be managed as per existing iCCM protocol. An independent outcome assessor will assess all enrolled infants on days 6 and 14 of enrolment for the study outcomes in both intervention and control clusters. Primary outcome will be clinical treatment failure by day 6. This trial will obtain approval from the WHO and site institutional ethics committees. Conclusions: If the research shows that CLHWs can effectively and safely treat fast breathing pneumonia in 7-59 days old young infants, it will increase access to pneumonia treatment substantially for infants living in communities with poor access to health facilities. Additionally, this evidence will contribute towards the review of the current iCCM protocol and its harmonization with IMCI protocol.Trial Registration:The trial is registered at AZNCTR International Trial Registry as ACTRN12617000857303.en_US
dc.identifier.affiliationsEnhanced Management of Pneumonia in Community (EMPIC) Study Groupen_US
dc.identifier.citationNisar Yasir Bin. Management of fast breathing pneumonia in young infants aged 7 to 59 days by community level health workers: protocol for a multi-centre cluster randomized controlled trial. International Journal of Clinical Trials. 2020 Apr; 7(2): 83-93en_US
dc.identifier.issn2349-3240
dc.identifier.issn2349-3259
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/200951
dc.languageenen_US
dc.publisherMedip Academyen_US
dc.relation.issuenumber2en_US
dc.relation.volume7en_US
dc.source.urihttps://dx.doi.org/10.18203/2349-3259.ijct20201715en_US
dc.subjectYoung infanten_US
dc.subjectEnhanced case managementen_US
dc.subjectiCCMen_US
dc.subjectCommunity level health workeren_US
dc.subjectPulse oximeteren_US
dc.subjectFast breathing pneumoniaen_US
dc.subjectAmoxicillinen_US
dc.titleManagement of fast breathing pneumonia in young infants aged 7 to 59 days by community level health workers: protocol for a multi-centre cluster randomized controlled trialen_US
dc.typeJournal Articleen_US
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