Integrated Treatment Protocol for Acute Malnutrition: A Non Inferiority Trial in Burkina Faso

Study Overview
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Brief Summary
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MUAC only is a pilot trial external control carried out between January 2017 and December 2017 in the Yako district (northern region), Burkina Faso. The objective of this study is to evaluate an integrated protocol for acute malnourished children without medical complication. The hypotheses of the integrated protocol include : A global treatment of acute malnutrition (moderate and severe) with a single treatment (RUTF) would improve the functioning of the program through early identification of acutely malnourished children, while achieving a better coverage and using a single supply chain. A gradual reduction of RUTF dosage according to a child's MUAC status could significantly increase the number of children on treatment without increasing overall RUTF quantity while maintaining similar recovery rates.

Detailed Description
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Objectives : Main objective : To ensure the recovery rate of the integrated protocol for treatment of acute malnutrition is significantly greater than 75% (reference value of the national program in BF). Secondary objectives : To ensure the mortality rate of the integrated protocol for treatment of acute malnutrition is significantly lower than 3% (reference value of the national BF program). To ensure the default rate of the integrated protocol for treatment of acute malnutrition is significantly lower than 15% (reference value of the national BF program). To ensure the non-response rate of the integrated protocol for treatment of acute malnutrition is significantly lower than 8%. To ensure the hospitalization rate of the integrated protocol for treatment of acute malnutrition is significantly lower than 15%. To ensure the coverage rate of the program increases by 30% after the year the integrated protocol was introduced (specific protocol annexed). To estimate the relapse rate of the integrated protocol for treatment of acute malnutrition. To compare RUTF rations per child of the integrated protocol compared to the national protocol Methods : The study population will include all acutely malnourished children aged between 6 and 59 months seeking consultations at all of the health centers in Yako District between January 2017 and December 2017. The study will be implemented in Burkina Faso's Yako District, which includes 54 health centers.

Official Title
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Effectiveness of an Integrated Treatment Protocol for Acute Malnutrition: A Non Inferiority Trial in Passore Province (Northern Region), Burkina Faso

Conditions
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Global Acute Malnutrition (GAM)

Intervention / Treatment
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* Drug: Ready to Use Therapeutic Food (RUTF)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being between 6 and 59 months old New admission Acute malnutrition defined as follows: MUAC<125mm MUAC> 125mm AND WHZ (Z-score) <-3 (WHO standard) Edema Resident in the study area (Yako district) Signed informed consent of the mother or the child's guardian Exclusion Criteria: Children allergic to milk, peanuts and / or RUTF

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MUAC<125mm<br>no medical complication | Drug: Ready to Use Therapeutic Food (RUTF)<br>* MUAC used as the primary admission and exit criteria for children with MUAC <125mm and no medical complication. Single treatment of RUTF for severe and moderate malnourished children and gradual reduction of doses according to the MUAC and the weight of the child during treatment. MUAC split into 3 categories: MUAC <115 mm: 175 kcal /kg/day 115 <MUAC <120mm: 125kcal/kg/day 120 <MUAC <125mm: 75kcal/kg/day<br>* Other names: MUAC<125mm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery rate | The recovery is defined as below : Minimum of 4 weeks of participation in the program MUAC> = 125 mm on 2 consecutive visits No edema for minimum 2 weeks Good Clinical Health | Between 4 and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate |  | Between inclusion and week 12 | 
| Default rate | Patient absent for 3 consecutive visits | Between 3 and 12 weeks | 
| Non-respondent rate | Patient who not reach the recovery criteria after twelve weeks in the program | 12 weeks after inclusion | 
| Hospitalization rate |  | Between inclusion and week 12 | 
| Relapse rate | Patient having reached the recovery criteria and returning for a new episode of malnutrition (MUAC<125mm). The children's MUAC will be measured at home 3 months after program exit. For organizational and financial reasons, this data will not be collected for all children. A specific protocol explaining the sampling and organization of data collection will be annexed to the protocol. | up to 3 months | 
| RUTF rations | Total number of RUTF bags received per child during participation in the program. | Between inclusion and week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MUAC, Acute malnutrition, RUTF, Children, Burkina Faso