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

Global Acute Malnutrition (GAM) Clinical Trial

— MUAC-Only  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03027505
• Other study ID #: MUAC Only Burkina Faso
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: April 2018

Study information

• Verified date: January 2019
• Source: Alliance for International Medical Action
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4958
• Est. completion date: April 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

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

Related Conditions & MeSH terms

• Global Acute Malnutrition (GAM)
• Malnutrition

Intervention

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

Locations

Country	Name	City	State
Burkina Faso	ALIMA	Yako	Region Nord

Sponsors (5)

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

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery rate	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	Between 4 and 12 weeks
Secondary	Mortality rate		Between inclusion and week 12
Secondary	Default rate	Patient absent for 3 consecutive visits	Between 3 and 12 weeks
Secondary	Non-respondent rate	Patient who not reach the recovery criteria after twelve weeks in the program	12 weeks after inclusion
Secondary	Hospitalization rate		Between inclusion and week 12
Secondary	Relapse rate	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.	up to 3 months
Secondary	RUTF rations	Total number of RUTF bags received per child during participation in the program.	Between inclusion and week 12

External Links

•   ALIMA website