ComPAS Low-WAZ RCT Mali

International Rescue Committee

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Acute Malnutrition in Childhood; Underweight; Acute Malnutrition in Infancy

Treatments: Dietary Supplement: No nutritional treatment; Dietary Supplement: Standard dose of ready-to-use therapeutic food (RUTF); Dietary Supplement: Simplified dose of ready-to-use therapeutic food (RUTF)

Study type: Interventional

Funder types: Other

Identifiers

NCT05248516

H 1.00.033

Details and patient eligibility

About

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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,500 participants in 3 patient groups

Control

Other group

Description:

no nutritional treatment administered

Treatment:

Dietary Supplement: No nutritional treatment

Simplified treatment

Experimental group

Description:

children are provided with 1 sachet of RUTF until discharge

Treatment:

Dietary Supplement: Simplified dose of ready-to-use therapeutic food (RUTF)

Standard treatment

Active Comparator group

Description:

children are provided nutritional treatment according to their weight-for-height z-score (WHZ) and their weight: 1. children with a WHZ\<-3 will receive 200kcal/kg/d of nutritional product until discharge 2. children with a WHZ between -3 and -2 are provided with 1 sachet of RUTF until discharge 3. children with a WHZ \>= -2 will not be provided any nutritional treatment

Treatment:

Dietary Supplement: Standard dose of ready-to-use therapeutic food (RUTF)