Community case management of chest indrawing pneumonia in children aged 2 to 59 months by community health workers: study protocol for a multi-country cluster randomized open label non-inferiority trial

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dc.contributor.authorNisar, Yasir Binen_US
dc.date.accessioned2020-05-06T08:34:23Z
dc.date.available2020-05-06T08:34:23Z
dc.date.issued2020-04
dc.description.abstractBackground:The World Health Organization (WHO) integrated management of childhood illness (IMCI) protocol recommends treatment of chest indrawing in 2-59 months old children with oral amoxicillin by trained health facility workers. Whereas, the WHO/UNICEF integrated community case management (iCCM) protocol recommends referral by community level health workers (CLHWs) to a health facility. This study aims to evaluate whether CLHWs can treat chest indrawing pneumonia effectively and safely.Methods:Thismulti-centre cluster randomized controlled open label, non-inferiority trial will be conductedin Bangladesh, Ethiopia, India and Malawi. All sites will use a common protocol with the same study design, participants, intervention, control and outcomes. CLHWs will identify 2-59 months old children with chest indrawing. Study supervisors, trained in the iCCM protocol, will confirm CLHWs’ findings. Pulse oximetry will be used to identify hypoxaemic children. In the intervention group, enrolled children will be treated with oral amoxicillin for 5 days, and in the control group they will be referred to ahealth facility, after providing first dose of oral amoxicillin. An independent outcome assessor will visit each enrolled child on days 6 and 14 of enrolment, to assess study outcomes.Conclusions:If CLHWs can effectively and safely treat chest indrawing pneumonia in 2-59 months old children, it will increase access to pneumonia treatment substantially, as in many settings, health facilities and trained health workers are not easily accessible. Moreover, this evidence will contribute towards the review of the current iCCM protocol and its harmonization with the IMCI protocol. Trial Registration:The trial is registered at AZNCTR International Trial Registry as ACTRN12617000857303en_US
dc.identifier.affiliationsEnhanced Management of Pneumonia in Community (EMPIC) Study Groupen_US
dc.identifier.citationNisar Yasir Bin . Community case management of chest indrawing pneumonia in children aged 2 to 59 months by community health workers: study protocol for a multi-country cluster randomized open label non-inferiority trial. International Journal of Clinical Trials. 2020 Apr; 7(2): 131-141en_US
dc.identifier.issn2349-3240
dc.identifier.issn2349-3259
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/200956
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.ijct20201719en_US
dc.subjectChildren under five years of ageen_US
dc.subjectChest indrawing pneumoniaen_US
dc.subjectEnhanced community case managementen_US
dc.subjectiCCMen_US
dc.subjectCommunity level health workeren_US
dc.subjectAmoxicillinen_US
dc.subjectPulse oximeteren_US
dc.titleCommunity case management of chest indrawing pneumonia in children aged 2 to 59 months by community health workers: study protocol for a multi-country cluster randomized open label non-inferiority trialen_US
dc.typeJournal Articleen_US
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