Nutritional, Metabolic, Endocrine Paediatrics
Conditions
Interventions
SAM Control
SAM Experimental A
SAM Experimental B
MAM Control
MAM Experimental A
MAM Experimental B
Post Recovery Standard of Care
Post Recovery Scheduled Followup
Post Recovery family MUAC
Sponsors
Action Against Hunger
Ethiopian Public Health Institute
University of Washington
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: SAM Cohort: 1. Age 6-59 months 2. Reside in the catchment area of the health post where the trial is to be conducted without plans to leave the area over the next year 3. Uncomplicated severe acute malnutrition, as defined by no signs of severe illness that would require referral to inpatient facility 4. Pass appetite test conducted at the time of enrollment 5. Consent for randomization into the study given by mother, father, and/or other primary caregiver 6. Mid-upper arm circumference less than 115 mm and/or nutritional edema 7. Weight-for-height Z-score (WHZ) less than -3 (will not count towards planned sample size) MAM Cohort: 1. Age 6-59 months 2. Reside in the catchment area of the health post where the trial is to be conducted without plans to leave the area over the next year 3. Uncomplicated moderate acute malnutrition, as defined by no signs of severe illness that would require referral to inpatient facility 4. Pass appetite test conducted at the time of enrollment 5. Consent for randomization into the study given by mother, father, and/or other primary caregiver 6. Mid-upper arm circumference of 115-124 mm without nutritional edema 7. Weight-for-height Z-score (WHZ) between -2 and -3 (will not count towards planned sample size) Followup Cohort: 1. Children 6-59 months of old who recovered from SAM or MAM following treatment in either of the SAM or MAM intervention trials
Exclusion criteria
Exclusion criteria: All Cohorts: 1. Complicated acute malnutrition with severe illness requiring transfer to a stabilization center or hospital for treatment. This includes, but is not limited to: a. Hypothermia b. High fever c. Signs of hypoglycemia d. Lethargy or altered mental status e. Moderate to severe dehydration f. Shock g. Other medical complications requiring hospitalization or higher-level medical evaluation 2. Treatment for acute malnutrition, either as an inpatient or outpatient, within the past 3 months 3. Known chronic medical illness such as severe cerebral palsy, severe congenital anomalies such as unrepaired congenital heart disease, Down syndrome, hydrocephalus, unrepaired cleft lip or palate, or other conditions that would be expected to contribute to difficulty feeding the prescribed amounts of therapeutic or supplementary food.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SAM cohort -- short-term nutritional recovery from SAM;MAM cohort -- short-term nutritional recovery from MAM ;Followup cohort -- number of episodes of relapse to acute malnutrition identified | — |
Secondary
| Measure | Time frame |
|---|---|
| Followup cohort -- mortality;SAM cohort -- weight gain during treatment, as measured in g, g/kg/d, WAZ, and WHZ;SAM cohort -- MUAC gain during treatment, as measured in mm, mm/d, and MUACZ;SAM cohort -- length/height gain during treatment, as measured in cm, mm/d, and HAZ;SAM cohort -- changes to body composition as measured by electrical impedance;SAM cohort -- changes in immunological function during treatment as measured by quantification of T-cell recombination excision circles (TRECs) and kappa-deleting recombination excision circles (KRECs) on dried blood spots;SAM cohort -- rates of acute illness, including diarrhea, vomiting, and fever during treatment;SAM cohort -- mortality;SAM cohort -- hospitalization;SAM cohort -- duration of treatment required prior to short-term recovery;SAM cohort -- medium-term vital and nutritional status, including rates of relapse to SAM and MAM, hospitalization, loss to follow-up, and mortality;SAM cohort -- medium-term weight gain;SAM cohort -- medium-term MUAC gain;SAM cohort -- medium-term length/height gain;SAM cohort -- medium-term body composition and immunological function;SAM cohort -- short-term cost-efficiency;SAM cohort -- medium-term cost-efficiency;MAM cohort -- weight gain during treatment, as measured in g, g/kg/d, WAZ, and WHZ;MAM cohort -- MUAC gain during treatment, as measured in mm, mm/d, and MUACZ;MAM cohort -- length/height gain during treatment, as measured in cm, mm/d, and HAZ;MAM cohort -- changes to body composition as measured by electrical impedance;MAM cohort -- changes in immunological function during treatment as measured by quantification of T-cell recombination excision circles (TRECs) and kappa-deleting recombination excision circles (KRECs) on dried blood spots;MAM cohort -- rates of acute illness, including diarrhea, vomiting, and fever during treatment;MAM cohort -- mortality;MAM cohort -- hospitalization;MAM cohort -- duration of treatment required prior to short-term recovery;MAM cohort -- | — |
Countries
Ethiopia
Contacts
Public ContactIndi Trehan
University of Washington Associate Professor
Outcome results
None listed