The effect of rice-based, lactose-free F-75 therapeutic formula on diarrhoea in the treatment of children with severe acute malnutrition

Number of days with diarrhoea during treatment with modified F-75, measured using a validated stool diary daily from admission to transition

1. Number of days with diarrhoea during hospitalization, measured using a validated stool diary daily from admission to discharge
2. Incidence of diarrhoea, defined as the proportion of children with minimum one day of diarrhoea, measured at transition and discharge
3. Severity of diarrhoea, assessed using the Vesikari scale daily
4. Consumption and feeding patterns:
4.1. Food intake in ml and duration of the meal measured as 3 time categories daily from admission to transition
4.2. Acceptability using a 5-point hedonic scale on day 2 and at transition
5. Number of days of the first stabilization phase and total number of days spent in the stabilization phase if the child deteriorates and resumes stabilization treatment. Duration of the first stabilization period is defined as: total number of days from admission to the day the child is considered stabilized for the first time. Total number of days spent in stabilization is defined as the total number of days whereby a child is “in the stabilization phase”. It includes the first stabilization phase and any periods when the child may go back to the stabilization phase due to deterioration of health. A child is considered to be stabilized when all these criteria are fulfilled: 1) Return of appetite; the child easily finishes all the prescribed feeds of F-75 and demands for more; 2) Reduced or minimal bilateral pitting oedema (reduced to grade 2 or grade 1); 3) Medical complications resolving; the child may also smile at this stage.
6. Number of days of hospital stay, calculated from the day of admission to discharge. Both days are included in hospitalization duration
7. Plasma electrolyte concentrations (P, Mg, K, Na, Cl, bicarbonate) measured at admission, two days after admission and at transition
8. Degree of dehydration (no, some, severe dehydration and shock), assessed at transition and discharge. Dehydration measured daily throughout hospitalization according to the WHO/Ugandan IMAM guidelines for assessment and treatment of dehydration in severely malnourished children. The highest degree of dehydration in the previous 24 hours is noted
9. Number of new onset severe clinical deteriorations, measured daily during hospitalization, defined as a new onset of any of the WHO danger signs:
9.1. Severe dehydration
9.2. Shock (lethargic or unconscious and has cold peripheries as well as either capillary refill time >3 secs or fast and weak pulse)
9.3. Severe respiratory distress (respiratory rate ≥ 40/50 bpm for children above/below 1 year respectively and severe chest in-drawing, grunting, nasal flaring, central cyanosis and hypoxemia (SPO2<90%)
9.4. Impaired consciousness (modified Glasgow coma scale < 15)
9.5. Cardiac failure (the cardinal signs of cardiac failure includes: tachycardia, tachypnoea, tender hepatomegaly)
9.6. Hypoglycemia (blood glucose less than 3 mmol/l)
9.7. Hypothermia (temperature below 35C, axillary temperature)
9.8. Hyperthermia (temperature above 39.5C, axillary temperature)
9.9. Severe anaemia (Hb below 4g/dl)
9.10. Convulsions
10. Child development, measured using the Malawi Developmental Assessment Tool at discharge

Auxiliary outcomes:
1. Mortality during hospitalization
2. Stool pH and reducing substances, measured using pH strips and Benedict’s solution at admission, day 2 and transition and if lactose intolerance is suspected
3. Gut microbiota, measured using 16S rRNA gene amplicon Illumina based high throughput sequencing at admission, transition and discharge
4. Gut function: plasma citrulline, faecal myeloperoxidase and faecal neopterine measured using mass spectrometry/ELISA test at admission, transition and discharge
5. Body composition, measured using bio-electrical impedance analysis at discharge
6. Fatty acid profile, measured using high-throughput GLC on whole blood dry blood spots at admission, transition and discharge