EFFECTIVENESS OF SIMPLIFIED APPROACH FOR THE MANAGEMENT OF WASTING AMONG CHILDREN (6-59 MONTHS) COMPARED TO STANDARD APPROACH IN ETHIOPIA: A NON-INFERIORITY RANDOMIZED CONTROLLED TRIA
- Conditions
- Nutritional, Metabolic, Endocrine
- Registration Number
- PACTR202202496481398
- Lead Sponsor
- ICEF
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1034
•Children 6–59 months with uncomplicated acute malnutrition
•MUAC <125 mm and/or
•Bilateral pitting oedema (+/++) and
• Passes the appetite test (consumption of some RUTF) and
•No medical complications (i.e. no features of severe illness as defined by the Integrated Management of Childhood illness)
•Severe anaemia is defined as hemoglobin concentration < 4g/dl.
•Children with severe dehydration.
•Children with hypothermia or infection.
•Plans to leave the catchment area in the next 6 months.
•Malformation or handicap which may affect food intake such as cleft palate, cerebral palsy, Down's syndrome
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recovery rate/Cure rate <br><br>
- Secondary Outcome Measures
Name Time Method ength of stay <br>Average weekly weight gain<br>Average weekly MUAC gain<br>Cost effectiveness