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

NCT03027505 | Completed DMC

• 1 other identifier: MUAC Only Burkina Faso
• Study Type: interventional
• Target: 4,958
• Locations: 1 country
• Sites: 1

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. 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. 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)

Keywords

MUAC; Acute malnutrition; RUTF; Children; Burkina Faso

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Mortality rate

  Between inclusion and week 12

• Default rate

  Between 3 and 12 weeks

• Non-respondent rate

  12 weeks after inclusion

• Hospitalization rate

  Between inclusion and week 12

• Relapse rate

  up to 3 months

Study Arms (1)

MUAC<125mm

EXPERIMENTAL

no medical complication

Drug: Ready to Use Therapeutic Food (RUTF)

Interventions

Ready to Use Therapeutic Food (RUTF) DRUG

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

Also known as: MUAC<125mm

MUAC<125mm

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Children allergic to milk, peanuts and / or RUTF

Sponsors & Collaborators

• Alliance for International Medical Action: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Association Keoogo: collaborator
• Institut de Recherche en Sciences de la Sante, Burkina Faso: collaborator
• SOS médecins Burkina Faso: collaborator

Study Sites (1)

ALIMA

Yako, Nord Region, Burkina Faso

Location

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 23, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: April 1, 2018
• Last Updated: January 30, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)