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Effectiveness of an Integrated Treatment Protocol for Acute Malnutrition: A Non Inferiority Trial in Passore Province (Northern Region), Burkina Faso (NCT03027505)

Institut National de la Santé Et de la Recherche Médicale, France
Association Keoogo
Institut de Recherche en Sciences de la Sante, Burkina Faso
SOS médecins Burkina Faso
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 : 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.
  • 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: MUAC <115 mm: 175 kcal /kg/day 115 <MUAC <120mm: 125kcal/kg/day 120 <MUAC <125mm: 75kcal/kg/day
    • MUAC<125mm
Ages eligible for Study
6 Months to 59 Months
Genders eligible for Study
All
Accepts 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
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.

In total, a projected 12 000 children could be included.

1 locations

Burkina Faso (1)
  • ALIMA
    recruiting
    Yako, Region Nord, Burkina Faso
Status:
recruiting
Type:
Interventional
Phase:
-
Start:
31 December, 2016
Updated:
23 January, 2017
Participants:
12000
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