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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03027505
Acronym
MUAC-Only
Enrollment
4958
Registered
2017-01-23
Start date
2017-01-31
Completion date
2018-04-30
Last updated
2019-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Global Acute Malnutrition (GAM)

Keywords

MUAC, Acute malnutrition, RUTF, Children, Burkina Faso

Brief summary

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 : 1. 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. 2. 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

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.

Interventions

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

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
Association Keoogo
CollaboratorUNKNOWN
Institut de Recherche en Sciences de la Sante, Burkina Faso
CollaboratorOTHER_GOV
SOS médecins Burkina Faso
CollaboratorUNKNOWN
Alliance for International Medical Action
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recovery rateBetween 4 and 12 weeksThe 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

Secondary

MeasureTime frameDescription
Default rateBetween 3 and 12 weeksPatient absent for 3 consecutive visits
Non-respondent rate12 weeks after inclusionPatient who not reach the recovery criteria after twelve weeks in the program
Mortality rateBetween inclusion and week 12
Relapse rateup to 3 monthsPatient 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.
RUTF rationsBetween inclusion and week 12Total number of RUTF bags received per child during participation in the program.
Hospitalization rateBetween inclusion and week 12

Countries

Burkina Faso

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026