Afficher la notice abrégée

Simplifying and optimising management of acute malnutrition in children aged 6 to 59 months: study protocol for a community-based individually randomised controlled trial in Kasai, Democratic Republic of Congo

dc.rights.licenseopenen_US
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorCAZES, Cecile
dc.contributor.authorPHELAN, K.
dc.contributor.authorHUBERT, V.
dc.contributor.authorALITANOU, R.
dc.contributor.authorBOUBACAR, H.
dc.contributor.authorIZIE BOZAMA, L.
dc.contributor.authorTSHIBANGU SAKUBU, G.
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorBEUSCART, Aurelie
dc.contributor.authorYAO, C.
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorGABILLARD, Delphine
dc.contributor.authorKINDA, M.
dc.contributor.authorAUGIER, A.
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorANGLARET, Xavier
dc.contributor.authorSHEPHERD, S.
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorBECQUET, Renaud
dc.date.accessioned2021-03-08T11:03:08Z
dc.date.available2021-03-08T11:03:08Z
dc.date.issued2020-12-02
dc.identifier.issn2044-6055 (Electronic) 2044-6055 (Linking)en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/26451
dc.description.abstractEnINTRODUCTION: Acute malnutrition (AM) is a continuum condition, arbitrarily divided into moderate and severe AM (SAM) categories, funded and managed in separate programmes under different protocols. Optimising acute MAlnutrition (OptiMA) treatment aims to simplify and optimise AM management by treating children with mid-upper arm circumference (MUAC) <125 mm or oedema with one product-ready-to-use therapeutic food-at a gradually tapered dose. Our main objective was to compare the OptiMA strategy with the standard nutritional protocol in children 6-59 months presenting with MUAC <125 mm or oedema without additional complications, as well as in children classified as uncomplicated SAM (ie, MUAC <115 mm or weight-for-height Z-score (WHZ) <-3 or with oedema). METHODS AND ANALYSIS: This study was a non-inferiority, individually randomised controlled clinical trial conducted at community level in the Democratic Republic of Congo. Children 6-59 months presenting with MUAC <125 mm or WHZ <-3 or with bipedal oedema and without medical complication were included after signed informed consent in outpatient health facilities. All participants were followed for 6 months. Success in both arms was defined at 6 months post inclusion as being alive, not acutely malnourished per the definition applied at inclusion and without an additional episode of AM throughout the 6-month observation period. Recovery among children with uncomplicated SAM was the main secondary outcome. For the primary objective, 890 participants were needed, and 480 children with SAM were needed for the main secondary objective. We will perform non-inferiority analyses in per-protocol and intention-to-treat basis for both outcomes. ETHICS AND DISSEMINATION: Ethics approvals were obtained from the National Health Ethics Committee of the Democratic Republic of Congo and from the Ethics Evaluation Committee of Inserm, the French National Institute for Health and Medical Research (Paris, France). We will submit results for publication to a peer-reviewed journal and disseminate findings in international and national conferences and meetings. TRIAL REGISTRATION NUMBER: NCT03751475. Registered 19 September 2018, https://clinicaltrials.gov/ct2/show/NCT03751475.
dc.language.isoENen_US
dc.rightsAttribution 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/us/*
dc.title.enSimplifying and optimising management of acute malnutrition in children aged 6 to 59 months: study protocol for a community-based individually randomised controlled trial in Kasai, Democratic Republic of Congo
dc.title.alternativeBMJ Openen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1136/bmjopen-2020-041213en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed33268424en_US
bordeaux.journalBMJ Openen_US
bordeaux.pagee041213en_US
bordeaux.volume10en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue12en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.teamIDLICen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-03162119
hal.version1
hal.date.transferred2021-03-08T11:03:13Z
hal.exporttrue
bordeaux.COinSctx_ver=Z39.88-2004&amp;rft_val_fmt=info:ofi/fmt:kev:mtx:journal&amp;rft.jtitle=BMJ%20Open&amp;rft.date=2020-12-02&amp;rft.volume=10&amp;rft.issue=12&amp;rft.spage=e041213&amp;rft.epage=e041213&amp;rft.eissn=2044-6055%20(Electronic)%202044-6055%20(Linking)&amp;rft.issn=2044-6055%20(Electronic)%202044-6055%20(Linking)&amp;rft.au=CAZES,%20Cecile&amp;PHELAN,%20K.&amp;HUBERT,%20V.&amp;ALITANOU,%20R.&amp;BOUBACAR,%20H.&amp;rft.genre=article


Fichier(s) constituant ce document

Thumbnail
Nom:
BPH_BMJO_2020_Cazes.pdf
Taille:
514.2Ko
Format:
PDF
Voir/Ouvrir
Thumbnail
Nom:
license_rdf
Taille:
914octets
Format:
application/rdf+xml
Voir/Ouvrir

Ce document figure dans la(les) collection(s) suivante(s)

Afficher la notice abrégée