Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-03-03 @ 6:44 PM
Study NCT ID:
NCT03027505
Status:
COMPLETED
Last Update Posted:
2019-01-30
First Post:
2017-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrated Treatment Protocol for Acute Malnutrition: A Non Inferiority Trial in Burkina Faso
Sponsor:
Alliance for International Medical Action
Organization:
Study Overview
Official Title:
Effectiveness of an Integrated Treatment Protocol for Acute Malnutrition: A Non Inferiority Trial in Passore Province (Northern Region), Burkina Faso
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MUAC-Only
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: