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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 : Recruiting
First Posted : January 23, 2017
Last Update Posted : January 25, 2017
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

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Global Acute Malnutrition (GAM) Drug: Ready to Use Therapeutic Food (RUTF) Not Applicable

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.

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of an Integrated Treatment Protocol for Acute Malnutrition: A Non Inferiority Trial in Passore Province (Northern Region), Burkina Faso
Study Start Date : January 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arm Intervention/treatment
Experimental: MUAC<125mm
no medical complication
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Mortality rate [ Time Frame: Between inclusion and week 12 ]
  2. Default rate [ Time Frame: Between 3 and 12 weeks ]
    Patient absent for 3 consecutive visits

  3. Non-respondent rate [ Time Frame: 12 weeks after inclusion ]
    Patient who not reach the recovery criteria after twelve weeks in the program

  4. Hospitalization rate [ Time Frame: Between inclusion and week 12 ]
  5. 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.


  6. RUTF rations [ Time Frame: Between inclusion and week 12 ]
    Total number of RUTF bags received per child during participation in the program.



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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03027505


Contacts
Contact: Kevin Phelan, MD kevin.phelan@alima.ngo
Contact: Maguy Daures, M.Sc +33768429047 maguy.daures@gmail.com

Locations
Burkina Faso
ALIMA Recruiting
Yako, Region Nord, Burkina Faso
Contact: Mariama Issoufou, PhD       yako.cpadjoint@alima-ngo.org   
Sponsors and Collaborators
Alliance for International Medical Action
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
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

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: Study Protocole V3 dec 2016

Responsible Party: Alliance for International Medical Action
ClinicalTrials.gov Identifier: NCT03027505     History of Changes
Other Study ID Numbers: MUAC Only Burkina Faso
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Alliance for International Medical Action:
MUAC
Acute malnutrition
RUTF
Children
Burkina Faso

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders