Severe acute malnutrition without medical complications Nutritional, Metabolic, Endocrine
Conditions
Interventions
Current intervention as of 31/01/2022:
This study is a non-inferiority randomized controlled trial. Randomization will be done at the individual level in each of the 14 study health areas. Block rando
Sponsors
Action Against Hunger
Eligibility
Sex/Gender
All
Age
6 Months to 59 Months
Inclusion criteria
Inclusion criteria: 1. Children aged 6 to 59 months 2. Only one child per sibling included in the study 3. Severe acute malnutrition (weight-height index <-3 Z-score and/or mid-upper arm circumference <115 mm and/or bilateral edema (+: edema localized to the lower limbs; ++: edema localized to the lower and upper limbs) 4. Without medical complications 5. With conclusive appetite test 6. Living in the selected health zone 7. Consent to participate in the study (informed consent) 8. When there are several participants in the same sibling, only the first to be included in the study will be randomized. The others will automatically be included in the same group as the first one without being randomized and will not be taken into account in the analyses
Exclusion criteria
Exclusion criteria: 1. Inconclusive appetite test 2. Siblings of SAM children: any SAM child whose brother or sister (same father, same mother) is already enrolled in the study. Be careful, he/she will have to receive the same dose as his/her brother or sister outside the study in order not to create a bias with different doses within the same family 3. Declared allergy to peanut and/or milk 4. Previously treated for SAM in the past 6 months, including readmissions after program dropout, relapses and medical transfers 5. Malformation or disability or chronic pathologies that can affect food intake, such as cleft palate, cerebral palsy, trisomy 2, sickle cell anemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 25/03/2022: Weight gain velocity (g/kg/d) measured using scales weekly from admission to discharge Previous primary outcome measure as of 31/01/2022: Weight (kg) measured using scales weekly between admission and discharge, and then fortnightly after discharge for up to 3 months Previous primary outcome measure: Weight (kg) measured using scales at admission, at discharge, and then every 15 days up to 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 31/01/2022: 1. Acceptance of a reduced dose during SAM treatment by health care personnel and the community measured using discussion groups, in-depth interviews, and direct observation using interview and focus group guides as well as observation grids in November 2021. This survey will assess the perceptions of families and health care providers on the amount of RUTF received, consumption and use practices, and their attitude towards a possible dose reduction. 2. Relapse rate measured as the proportion of children treated for SAM and declared cured who revert to SAM within 3 months of completing treatment, using anthropometric measurements including weight (kg), height (cm), and arm circumference (mm) taken using scales, height chart and tape measure at 3 months after treatment 3. Psychomotor development measured using the Psychomotor Development Index (PDI) at admission, discharge, and 6 months after treatment 4. Duration of the edema melting measured as the number of days taken for the lower limbs of SAM children to return to their normal volume using a tape measure at all study visits 5. Length of stay measured as the number of days between admission and discharge (with discharge occurring at PB=12.5 cm and/or PT =-3 z-score and/or edema melt). The maximum length of stay is 12 weeks or 3 months 6. The cure rate measured as meeting the cure criteria according to admission category during two consecutive visits and no edema during two visits in two consecutive weeks measured using PT index (=-1.5) or PB (=125 mm) and edema at all study visits 7. The dropout rate measured as the proportion of children confirmed alive who missed two successive visits, at all study visits. The abandonment is confirmed once after the visit of the RECO which confirms that the child is alive despite his 2 absences during the weekly visits. Children who have been abandoned will be followed up to 3 months after the abandonment. For children who | — |
Countries
Congo, Democratic Republic
Outcome results
None listed