NCT05248516

ComPAS Low-WAZ RCT Mali

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,500 (estimated)
• Sponsor: International Rescue Committee · Academic / Other
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Acute Malnutrition in Infancy
• Acute Malnutrition in Childhood
• Underweight

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Simplified dose of ready-to-use therapeutic food (RUTF)	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.
DIETARY_SUPPLEMENT	Standard dose of ready-to-use therapeutic food (RUTF)	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.
DIETARY_SUPPLEMENT	No nutritional treatment	no nutritional treatment will be provided to children in the control arm.

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-12-31
• Completion: 2024-04-30
• First posted: 2022-02-21
• Last updated: 2024-01-03

Locations

11 sites across 1 country: Mali