Integrated Treatment Protocol for Acute Malnutrition: A Non Inferiority Trial in Burkina Faso (MUAC-Only)
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|ClinicalTrials.gov Identifier: NCT03027505|
Recruitment Status : Recruiting
First Posted : January 23, 2017
Last Update Posted : January 25, 2017
MUAC only is a non-inferiority trial with 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.
|Condition or disease||Intervention/treatment||Phase|
|Global Acute Malnutrition (GAM)||Drug: Ready to Use Therapeutic Food (RUTF)||Not Applicable|
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
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.
In total, a projected 12 000 children could be included.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of an Integrated Treatment Protocol for Acute Malnutrition: A Non Inferiority Trial in Passore Province (Northern Region), Burkina Faso|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||April 2018|
no medical complication
Drug: Ready to Use Therapeutic Food (RUTF)
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:
Other Name: MUAC<125mm
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03027505
|Contact: Kevin Phelan, MDfirstname.lastname@example.org|
|Contact: Maguy Daures, M.Scemail@example.com|
|Yako, Region Nord, Burkina Faso|
|Contact: Mariama Issoufou, PhD firstname.lastname@example.org|
|Principal Investigator:||Susan Shepherd, MD||Directrice de recherches Opérationnelles et Médicales, ALIMA, USA|
|Principal Investigator:||Renaud Becquet, MPH,PhD,HDR||Chercheur Inserm, Inserm U1219 Bordeaux Population Health Center-Université de Bordeaux|