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

NCT03027505 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4958

Last updated 2019-01-30

No results posted yet for this study

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.

Conditions

  • Global Acute Malnutrition (GAM)

Interventions

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

Sponsors & Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • Association Keoogo

    collaborator UNKNOWN

  • Institut de Recherche en Sciences de la Sante, Burkina Faso

    collaborator OTHER_GOV

  • SOS médecins Burkina Faso

    collaborator UNKNOWN

  • Alliance for International Medical Action

    lead OTHER

Principal Investigators

  • Susan Shepherd, MD · Directrice de recherches Opérationnelles et Médicales, ALIMA, USA

  • Renaud Becquet, MPH,PhD,HDR · Chercheur Inserm, Inserm U1219 Bordeaux Population Health Center-Université de Bordeaux

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-12-31
Completion
2018-04-30

Countries

  • Burkina Faso

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03027505 on ClinicalTrials.gov