Severe acute malnutrition Nutritional, Metabolic, Endocrine Unspecified protein-energy malnutrition
Conditions
Interventions
Total duration of treatment for the acceptability study is five weeks.
Soya, maize and sorghum based RUTF will be compared to the control of peanut based RUTF. All admitted children in both arms will
Sponsors
Irish Aid (Ireland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both male and female severely acutely malnourished children in the age range of 6 - 59 months 2. Mid-upper arm circumference less than 110 mm or oedema of + or ++ 3. Admitted into the Outpatient Therapeutic Programme at the health centre 4. Good appetite 5. No serious medical complication
Exclusion criteria
Exclusion criteria: There are no exclusion criteria to be used as all severely malnourished children with no complications need to be treated at the health centre level until recovery. However, severely malnourished children who do not have an appetite or have severe medical complications or marasmic-kwashiorkor will be first referred to the stabilisation centre (University Teaching Hospital) straight away. These children will be taken into the study once stabilised at the inpatient unit of University Teaching Hospital. They will receive the respective RUTF being used in the health centre then return to follow up treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Acceptability study: RUTF acceptability, measured at end of five weeks. Data will be analysed to compare the acceptability of the RUTFs compared. 2. Randomised trial: recovery rate. Data for recovery rate will be measured routinely and analysed on monthly basis, however final analysis will be done at the end of the study period. 3. Cost effectiveness evaluation: 3.1. Incremental cost per death prevented, and per recovered child, measured at the end of the study period 3.2. Probability that the intervention is cost effective for different levels of willingness to pay per outcome (e.g. US$150/DALY gained), measured at the end of the study period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Acceptability study: 1.1. Dietary intake, measured daily during the five week period 1.2. Morbidity, measured daily for the whole duration 1.3. Weight gain, measured at entry, at the end of week 2, the beginning of week 4 and the end of week 5. In week three will be a wash out period. 2. Randomised trial: 2.1. Defaulter rate. Data for default rate will be collected and analysed routinely. However final comparison will be made at the end of the study. 2.2. Average weight gain from baseline (or, in oedematous children, from time of loss of oedema) until exit from the programme. Weight gain will be measured for each individual child and an average taken at the end. This will be done for children who successfully complete the treatment. 2.3. Morbidity (diarrhoea, vomiting, fever, cough). Incidence of morbidity will be compared between the two groups on regular basis (weekly) and at the end of the study. 2.4. Hospital referral. The number of children referred and outcome for referral will be measured and compared at the end of the study. 2.5. Mortality. Mortality data will be collected and analysed routinely. However final analysis will be made at the end of the study and comparison between the two arms will be made. 2.6. Length gain. Data on height will be captured at admission, week four, week eight and at discharge. 3. Cost effectiveness evaluation: cost of Community-based Therapeutic Care, including RUTF, measured at the end of study period | — |
Countries
Zambia
Outcome results
None listed