Evidence map›Paper›PMID 38191436›Full record

ArticleTrials2024

Nutritional treatment of children 6-59 months with severely low weight-for-age z-score: a study protocol for a 3-arm randomized controlled trial.

Suvi T Kangas, Césaire T Ouédraogo, Moctar Tounkara, Bareye Ouoluoguem, Issa Niamanto Coulibaly, Alhousseyni Haidara, Niele Hawa Diarra, Koniba Diassana, Zachary Tausanovitch, Christian Ritz and 5 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05248516 (Simplified Treatment of Children With Low WAZ in Mali. A Randomized Controlled Trial), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05248516 phase2 / phase3unknown statusnot on this map

Simplified Treatment of Children With Low WAZ in Mali. A Randomized Controlled Trial

TypeinterventionalSponsorInternational Rescue CommitteeRan2022 to 2024Enrolled1,500ConditionsAcute Malnutrition in Infancy, Acute Malnutrition in Childhood, UnderweightArmsSimplified dose of ready-to-use therapeutic food (RUTF), Standard dose of ready-to-use therapeutic food (RUTF), No nutritional treatment
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Suvi T KangasInternational Rescue Committee, New York, USA. suvi.kangas@rescue.org.ORCID http://orcid.org/0000-0003-1477-7649
Césaire T OuédraogoInternational Rescue Committee, Bamako, Mali.
Moctar TounkaraDepartment of Education and Research in Public Health and Specialties, Faculty of Medicine and Dentistry, University of Sciences, Technics and Technologies of Bamako, Bamako, Mali.
Bareye OuoluoguemSub-Direction of Nutrition, Ministry of Health, Bamako, Mali.
Issa Niamanto CoulibalyInternational Rescue Committee, Bamako, Mali.
Alhousseyni HaidaraInternational Rescue Committee, Bamako, Mali.
Niele Hawa DiarraInternational Rescue Committee, Bamako, Mali.
Koniba DiassanaInternational Rescue Committee, Bamako, Mali.
Zachary TausanovitchInternational Rescue Committee, New York, USA.
Christian RitzNational Institute of Public Health, Copenhagen, Denmark.
Jonathan C WellsPopulation Policy and Practice Department, UCL Great Ormond Street Institute of Child Health, London, UK.
André BriendDepartment of International Health, University of Tampere School of Medicine, Tampere, Finland.
Mark MyattBrixton Health, Brixton, UK.
Elizabeth RadinInternational Rescue Committee, New York, USA.
Jeanette BaileyInternational Rescue Committee, New York, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAdmission criteria that treat children with low mid-upper-arm circumference (MUAC), and low weight-for-height z-score (WHZ) are not aligned with the evidence on which children are at risk of mortality. An analysis of community-based cohort data from Senegal found that a combination of weight-for-age (WAZ) and MUAC criteria identified all children at risk of near-term death associated with severe anthropometric deficits. This study will address whether children with WAZ <-3 but MUAC ≥125 mm benefit from therapeutic feeding with ready-to-use therapeutic foods (RUTF) and whether a simplified protocol is non-inferior to the weight-based standard protocol.

methodsThis is a prospective individually randomized controlled 3-arm trial conducted in the Nara health district in Mali. Children aged 6-59 months presenting with MUAC ≥125 mm and WAZ <-3 will be randomized to (1) control group receiving no treatment, (2) simplified treatment receiving 1 sachet of RUTF daily until WAZ ≥-3 for 2 visits, (3) standard treatment receiving RUTF according to WHZ category: (a) WHZ <-3 receive 200 kcal/kg/day until WHZ ≥-2 for 2 visits, (b) WHZ ≥-3 but <-2 receive 1 sachet daily until WHZ ≥-2 for 2 visits or (c) WHZ ≥-2 receive no treatment. All children will be followed up first fortnightly for 12 weeks and then monthly until 6 months post-enrolment. The primary endpoint will be measured at 2 months with the primary outcome being WAZ as a continuous measure. Other outcomes include other anthropometric measurements and a secondary endpoint will be observed at 6 months. A total of 1397 children will be recruited including 209 in the control and 594 in both the simplified and standard arms. The sample size should enable us to conclude on the superiority of the simplified treatment compared to no treatment and on the non-inferiority of the simplified treatment versus standard treatment with a margin of non-inferiority of 0.2 WAZ. DISCUSSION: This trial aims to generate new evidence on the benefit of treating children with WAZ <-3 but MUAC ≥125 mm in order to guide the choice of admission criteria to malnutrition treatment and build evidence on the most efficient treatment protocol.

trial registrationThis trial was registered at ClinicalTrials.gov: NCT05248516 on February 21, 2022.

Indexed as

FoodMalnutritionAnthropometryChildControl GroupsHumansProspective StudiesRandomized Controlled Trials as TopicAcute malnutritionCommunity-based management of acute malnutritionEfficacyMaliMid-upper-arm circumferenceModerate acute malnutritionReady-to-use therapeutic foodRelapseSevere acute malnutritionSimplified protocolStuntingTreatmentUnderweightWastingWeight-for-age z-score

Identifiers

PMID38191436
PMCPMC10773065

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.