Severe acute malnutrition (SAM) Nutritional, Metabolic, Endocrine Malnutrition
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 6 - 59 months 2. Children with severe acute malnutrition 3. Care-taker willing to come back for follow-up 4. Written informed consent obtained by parent or care-taker
Exclusion criteria
Exclusion criteria: 1. Patients with severe conditions and diseases 1.1. Shock at admission. Once stabilized, these children may be included. 1.2. Severe respiratory difficulty at admission. Once stabilized, these children may be included. 2. Weight below 4 kg at admission 3. Obvious disability, e.g. Cerebral palsy, hydrocephalus, Down?s syndrome 4. Significant congenital diseases, e.g. Congenital heart disease 5. Malignant diseases 6. Patients considered by study staff not to be able to participate in the study 7. Patients being admitted with SAM in the last 6 months 8. Patients participating in another study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 11/09/2015: Duration of diarrhea during hospitalization Previous primary outcome measures: Duration of diarrhea episodes (days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 11/09/2015: 1. Incidence and severity of diarrhea (during hospitalization and during the outpatient treatment period, respectively) and duration of diarrhea during the outpatient treatment period 2. Incidence, severity and duration of pneumonia (during hospitalization and during the outpatient treatment period, respectively) 3. Nutritional recovery based on weight gain (during hospitalization and during the outpatient treatment period, respectively) 4. Specific changes in gut microbiota, immune response and intestinal health markers as indicated in the study protocol (at discharge and after 8 weeks outpatient treatment) Diarrhea, pneumonia and weight gain are measured throughout the study. Diarrhea and pneumonia will be measured daily and weight gain will be measured daily during the hospitalization and fortnightly during the follow-up period. We will include all these measurements in the statistical analyses Previous secondary outcome measures: 1. Incidence and severity of diarrhea episodes (during hospitalization and during the outpatient treatment period, respectively) 2. Incidence, severity and duration of pneumonia episodes (during hospitalization and during the outpatient treatment period, respectively) 3. Nutritional recovery based on weight gain (during hospitalization and during the outpatient treatment period, respectively) 4. Specific changes in gut microbiota, immune response and intestinal health markers as indicated in the study protocol (at discharge and after 8 weeks outpatient treatment) Diarrhea, pneumonia and weight gain are measured throughout the study. Diarrhea and pneumonia will be measured daily and weight gain will be measured daily during the hospitalization and fortnightly during the follow-u | — |
Countries
Uganda