ComPAS Low-WAZ RCT Mali

International Rescue Committee1,500 enrolled

Overview

Admissions criteria which treat children with only low mid-upper arm circumference (MUAC) or children with 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 z-score (WAZ) and MUAC criteria identified all children at risk of near-term death associated with severe anthropometric deficits. This finding has led to the suggestion that WAZ\<-3 could be added as an independent admissions criterion for therapeutic feeding programs currently admitting children with MUAC\<125 mm. However, there is little evidence to inform the debate about whether children with MUAC ≥125 mm and WAZ\<-3 would benefit from treatment and, if so, what treatment protocol should be used. This study will address whether children with WAZ \<-3 but MUAC ≥125 mm benefit from therapeutic feeding and whether a simplified protocol is at least as effective as the more complicated weight-based standard protocol for this population. The study will be a prospective, multi-center, individually randomized controlled trial (RCT). Children aged 6-59 months presenting with MUAC ≥125 mm and WAZ\<-3 will be randomized to one of three study arms. The primary objective of this study is to assess whether therapeutic feeding with a simplified protocol (1 sachet RUTF/day) results in superior nutritional outcomes compared to no therapeutic feeding AND non-inferior nutritional outcomes compared to the WHZ and weight based dosing regimen currently used in CMAM treatment 2 months after diagnosis among children aged 6-59 months with MUAC ≥125 mm and WAZ\<-3 . The primary outcome is the mean WAZ of children. Secondary outcomes include a) proportion of children with WAZ \<-3, b) mean MUAC of children, c) proportion of children with MUAC \< 125 mm, d) mean WHZ, mean HAZ, e) proportion of children with WHZ\<-3 or HAZ\<-3, f) change in WAZ, MUAC, WHZ, HAZ from enrolment to endpoint g) mean skinfold thickness measure.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

Interventions

Simplified dose of ready-to-use therapeutic food (RUTF)DIETARY_SUPPLEMENT

In the simplified arm all children receive the same dose: 1 sachet of RUTF/day. This until discharge from treatment. Recovery from treatment will be defined as WAZ\>= -3 on 2 consecutive visits. A maximum of 12 treatment weeks are allowed before declaring non-response. Defaulting will be declared after 2 consecutively missed visits.

Standard dose of ready-to-use therapeutic food (RUTF)DIETARY_SUPPLEMENT

In the standard arm, children will receive different doses of RUTF depending on their WHZ category and weight. 1. children with a WHZ\<-3 will receive the equivalent of 200kcal/kg/d of RUTF until discharge. 2. children with a WHZ between -3 and -2 will receive 1 sachet (500kcal) of RUTF per day until discharge. 3. children with a WHZ\>=-2 will receive no nutritional treatment. Recovery from treatment will be defined as WHZ\>= -2 on 2 consecutive visits. A maximum of 12 treatment weeks are allowed before declaring non-response. Defaulting will be declared after 2 consecutively missed visits.

No nutritional treatmentDIETARY_SUPPLEMENT

no nutritional treatment will be provided to children in the control arm.

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 59 Months

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 6 and 59 months * MUAC ≥125 mm * WAZ \<-3 * Living in the study catchment area * Expects to be able to continue follow-up visits for next 6 months Exclusion Criteria: * nutritional edema * Known peanut or milk allergy * Severe illnesses requiring inpatient level treatment (according to IMCI guidelines) * Medical condition affecting food intake (lip and palate cleft, handicap etc.) * Has already taken part in the study

Locations (11)

Dilly

Nara, Koulikoro, Mali

Gassambarou

Nara, Koulikoro, Mali

Goumbou

Nara, Koulikoro, Mali

Kaloumba

Nara, Koulikoro, Mali

Karfabougou

Nara, Koulikoro, Mali

Koira

Nara, Koulikoro, Mali

Koronga

Nara, Koulikoro, Mali

Madina-Kagoro

Nara, Koulikoro, Mali

Nara Central

Nara, Koulikoro, Mali

Sampaga

Nara, Koulikoro, Mali

...and 1 more locations

Outcomes

Primary Outcomes

weight-for-age z-score (WAZ)

the primary outcome is a continuous outcome: a higher WAZ indicates of a positive outcome. To construct WAZ at any point in time, children's age will be calculated based on their age at admission and their weight will be measured at each time point with 0.1kg precision. WAZ will be calculated using zscore06 fonction in STATA that is based on the WHO growth reference data specific to each gender.

Time frame: 2 months after enrolment

Secondary Outcomes

weight-for-age z-score (WAZ)

the secondary outcome is a continuous outcome: a higher WAZ indicates a positive outcome. To construct WAZ at any point in time, children's age will be calculated based on their age at admission and their weight will be measured at each time point with 0.1kg precision. WAZ will be calculated using zscore06 fonction in STATA that is based on the WHO growth reference data specific to each gender.

Time frame: 6 months after enrolment

weight-for-age z-score (WAZ) <-3

this outcome is binary: a higher proportion of WAZ\<-3 indicates a negative outcome. To construct WAZ at any point in time, children's age will be calculated based on their age at admission and their weight will be measured at each time point with 0.1kg precision. WAZ will be calculated using zscore06 fonction in STATA that is based on the WHO growth reference data specific to each gender.