A multicentric study to compare the effectiveness of Community-based treatment programs to treat children aged 6-59 months with uncomplicated Severe Acute Malnutrition using alternative energy dense foods
- Conditions
- Health Condition 1: E43- Unspecified severe protein-caloriemalnutrition
- Registration Number
- CTRI/2020/09/028013
- Lead Sponsor
- Prof Praveen Kumar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 660
(i) Children aged 6-59 months fulfilling anthropometric as SAM as WHZ less than -3SD and
(ii) No medical complications and
(iii) Passed the appetite test and
(iv) Families are not planning to migrate out of the study area during the treatment period.
Note: However, if an enrolled child develops medical complication during the course of their treatment under the CSAM programme they will be referred to inpatient care and continue to be monitored in the study.
Additional Inclusion criteria for sub-set for body composition
(a) Informed consent will be taken from parents of the children for assessing body composition parameters before enrollement.
(b) Enrollment weight greater than 5kg
(i) Children with SAM identified with complications (including all grades of edema) during screening will be referred to the nearest nutrition rehabilitation centres (NRCs) for management.
(ii) Children with presence of emergency signs, edema, high fever, cough with fast breathing
(iii) Secondary SAM cases like neurological diseases such as cerebral palsy, TB, HIV congenital heart defects, congenital structural defects , cleft palate will be excluded
(iv) Children referred from NRC in CMAM Programme with partial recovery
(v) Defaulters from other programmes / FSAM programmes
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recovery of enrolled uncomplicated Severe Acute Malnourished childrenTimepoint: At enrollment and after 12 weeks
- Secondary Outcome Measures
Name Time Method Body composition parameters fat mass by skinfold thickness and fat free mass, body water by BIATimepoint: At enrollment and after 12 weeks;Defaulting, death, length of stay, average weekly weight gain and height gainTimepoint: After 12 weeks of enrollment;Relapse and mortality ratesTimepoint: Six months after exit from the programme