Completed

NCT Number: NCT03027505

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

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.

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Key information

Conditions

Global Acute Malnutrition (GAM)

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ALIMA

Yako, Nord Region, Burkina Faso

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ready to Use Therapeutic Food (RUTF)

Drug

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

Other names: MUAC<125mm

Primary outcomes

Recovery rate

Time frame: Between 4 and 12 weeks
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

Secondary outcomes

Mortality rate

Time frame: Between inclusion and week 12
Default rate

Time frame: Between 3 and 12 weeks

Patient absent for 3 consecutive visits
Non-respondent rate

Time frame: 12 weeks after inclusion

Patient who not reach the recovery criteria after twelve weeks in the program
Hospitalization rate

Time frame: Between inclusion and week 12
Relapse rate

Time frame: up to 3 months

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.
RUTF rations

Time frame: Between inclusion and week 12

Total number of RUTF bags received per child during participation in the program.

Sponsors and collaborators

Lead sponsor

Alliance for International Medical Action

Other

Collaborators

Association Keoogo
Institut National de la Santé Et de la Recherche Médicale, France
Institut de Recherche en Sciences de la Sante, Burkina Faso
SOS médecins Burkina Faso

Registry information

Official study title

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

Acronym: MUAC-Only

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2018
First posted: Jan 23, 2017
Registry last updated: Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.