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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 : Completed
First Posted : January 23, 2017
Last Update Posted : January 30, 2019
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Alliance for International Medical Action

Tracking Information
First Submitted Date  ICMJE January 17, 2017
First Posted Date  ICMJE January 23, 2017
Last Update Posted Date January 30, 2019
Actual Study Start Date  ICMJE January 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Integrated Treatment Protocol for Acute Malnutrition: A Non Inferiority Trial in Burkina Faso
Official Title  ICMJE Effectiveness of an Integrated Treatment Protocol for Acute Malnutrition: A Non Inferiority Trial in Passore Province (Northern Region), Burkina Faso
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Global Acute Malnutrition (GAM)
Intervention  ICMJE 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
Other Name: MUAC<125mm
Study Arms  ICMJE Experimental: MUAC<125mm
no medical complication
Intervention: Drug: Ready to Use Therapeutic Food (RUTF)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2019)
4958
Original Estimated Enrollment  ICMJE
 (submitted: January 19, 2017)
12000
Actual Study Completion Date  ICMJE April 2018
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 59 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Burkina Faso
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03027505
Other Study ID Numbers  ICMJE MUAC Only Burkina Faso
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alliance for International Medical Action
Study Sponsor  ICMJE Alliance for International Medical Action
Collaborators  ICMJE
  • 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
Investigators  ICMJE
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
PRS Account Alliance for International Medical Action
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP