Clinical trial NCT06792370: Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition
Official title: Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition in Children Aged 6-59 Months in Burkina Faso: Reduced Dose of RUTF for SAM Children and RUTF Instead of RUSF for MAM Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Malnutrition with No Complications
Keywords: Effectiveness
acute malnutrition
management
treatment
reduced dose
Ready-to-Use Supplementary Foods
Ready-to-Use Therapeutic Foods
uncomplicated
without complication
Lead sponsor: Institut de Recherche en Sciences de la Sante, Burkina Faso
Sponsor class: OTHER_GOV
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2025-01-24
Enrollment: 3521
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individually randomized and controlled trial
Primary purpose: TREATMENT

Brief summary: This experimental study aims to test an alternative protocol for managing acute malnutrition in children aged 6-59 months in Burkina Faso. This alternative protocol consists of using RUTF instead of RUSF for the management of moderate acute malnutrition and reduced-dose RUTF instead of standard-dose RUTF for the treatment of severe acute malnutrition.

The main questions are:

1. Does treating children with moderate acute malnutrition using RUTF lead to a non-inferior programmatic and sustained recovery rate compared to the standard care with RUSF?
2. Does treating children with uncomplicated severe acute malnutrition using a reduced dose of RUTF lead to a non-inferior programmatic and sustained recovery rate compared to the standard care with a standard dose of RUFT?

Secondly, the study will investigate the effect of this alternative protocol compared to the standard protocol on cost-effectiveness, psychomotor development, weight and linear growth and incidence of relapses.

Detailed description: In this trial, children presenting at the health center and fulfilling the inclusion criteria will be randomly allocated into one of the study groups in a ratio of 1:1:1 for severe acute malnutrition (SAM) without complication and 1:1 for moderate acute malnutrition (MAM).

Supplementation will be daily according to the child's weight for a maximum of 12 weeks, at which point the programmatic recovery assessment will be done. Those who recovered before or at this point will be subsequently followed up monthly for up to 3 months for sustained recovery assessment.

Follow-up visits will be done at the health center every week for children with SAM and every two weeks for children with MAM.

At each visit, anthropometric measurements will be performed; a morbidity questionnaire will be administered before the mother/caregiver receives the ration for the following period. For the measurement of adherence, mothers will be asked to bring back empty and unused sachets/packaging of supplements from the last visit. Questions will also be asked to the mother/caregiver on the difficulties encountered during consumption and the adverse events observed following the consumption of the supplements.

The evaluation of the psychomotor development will be performed in a subsample.

Eligibility criteria: 1. MAM

   Inclusion Criteria:
   * Anthropometric measures:

     * (115 mm ≤ MUAC\< 125 mm and -3 SDs ≤ WLZ \< -2 SDs) OR
     * (115 mm ≤ MUAC\< 125 mm and WLZ ≥ -2 SDs) OR
     * (MUAC ≥ 125 mm and -3 SDs ≤ WLZ \< -2 SDs).
   * Age: 6 to 59 months
   * Parents' acceptance of biweekly visits until programme discharge and monthly visits for the post-programme follow up

   Exclusion Criteria:
   * Failure of appetite test
   * Medical complications requiring hospital treatment
   * Presence of any congenital anomaly or underlying chronic disease that may affect growth or the risk of infection
   * Presence of bilateral oedema
   * History of allergies to peanuts, milk, or soya
   * Relapse from MAM treatment or transfer from SAM treatment
   * Children who have recently (\<2 months) taken part in a nutrition programme;
   * Residence outside the study area
   * Mother or caregivers deemed unable to comply with the necessary requirements of the study (particular medical condition of the mother or caregivers, etc.)
2. SAM

Inclusion Criteria:

* Anthropometric measures MUAC\< 115 mm or WLZ\< - 3 SDs;
* Age: 6-59 months;
* Parents' acceptance of weekly visits until programme discharge and monthly visits for the post-programme follow up.

Exclusion Criteria:

* Failure of appetite test
* Medical complications requiring hospital treatment
* Presence of any congenital anomaly or underlying chronic disease that may affect growth or the risk of infection
* Presence of bilateral oedema
* History of allergies to peanuts, milk or soya
* Relapse from MAM treatment or transfer from SAM treatment
* Children who have recently (\<2 months) taken part in a nutrition programme;
* Residence outside the study area;
* Mother or caregivers deemed unable to comply with the necessary requirements of the study (particular medical condition of the mother or caregivers, etc.)

Primary outcomes:
measure: Rate of programmatic recovery
timeFrame: From enrollment to the end of treatment (maximum 12 weeks)
measure: Rate of sustained recovery
timeFrame: from programmatic recovery to 3 months after
Secondary outcomes:
measure: Cost per child treated
timeFrame: From enrollment to the end of treatment (maximum 12 weeks)
measure: Cost per child recovered
timeFrame: From enrollment to the end of treatment (maximum 12 weeks)
measure: Score of the extended version of Developmental Milestones Checklist (DMC-II)
timeFrame: Three points : enrollment , exit of the supplementation program (up to 12 weeks) and exit of the study (3 months after recovery)
measure: Daily weight gain
timeFrame: From enrollment to the exit of the supplementation programme (maximum 12 weeks)]
measure: Daily length gain
timeFrame: [Time Frame: From enrollment to the exit of the supplementation programme (maximum 12 weeks)
measure: Energy intake
timeFrame: From enrollment to the exit of the supplementation programme (maximum 12 weeks)
measure: Rate of relapses
timeFrame: from programmatic recovery to 3 months after
measure: Length of stay
timeFrame: From enrollment to the exit of the supplementation programme (maximum 12 weeks)
measure: Rate of defaulted
timeFrame: From enrollment to the exit of the supplementation programme (maximum 12 weeks)
measure: Rate of treatment failure
timeFrame: From enrollment to the end of treatment (maximum 12 weeks)
measure: Number of adverse events
timeFrame: From enrollment to the exit of the supplementation programme (maximum 12 weeks)
Other outcomes:
Locations:
city: Ouagadougou
country: Burkina Faso
facility: Institut de Recherche en Sciences de la Santé
state: Kadiogo
Study officials:
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