Clinical trial NCT03027505: Integrated Treatment Protocol for Acute Malnutrition: A Non Inferiority Trial in Burkina Faso
Official title: Effectiveness of an Integrated Treatment Protocol for Acute Malnutrition: A Non Inferiority Trial in Passore Province (Northern Region), Burkina Faso
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Global Acute Malnutrition (GAM)
Keywords: MUAC
Acute malnutrition
RUTF
Children
Burkina Faso
Lead sponsor: Alliance for International Medical Action
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Association Keoogo
name: Institut de Recherche en Sciences de la Sante, Burkina Faso
name: SOS médecins Burkina Faso
First posted: 2017-01-23
Enrollment: 4958
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recovery rate
timeFrame: Between 4 and 12 weeks
Secondary outcomes:
measure: Mortality rate
timeFrame: Between inclusion and week 12
measure: Default rate
timeFrame: Between 3 and 12 weeks
measure: Non-respondent rate
timeFrame: 12 weeks after inclusion
measure: Hospitalization rate
timeFrame: Between inclusion and week 12
measure: Relapse rate
timeFrame: up to 3 months
measure: RUTF rations
timeFrame: Between inclusion and week 12
Other outcomes:
Locations:
city: Yako
country: Burkina Faso
facility: ALIMA
state: Region Nord
Study officials:
affiliation: Directrice de recherches Opérationnelles et Médicales, ALIMA, USA
name: Susan Shepherd, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chercheur Inserm, Inserm U1219 Bordeaux Population Health Center-Université de Bordeaux
name: Renaud Becquet, MPH,PhD,HDR
role: PRINCIPAL_INVESTIGATOR
References: