Inpatient in the paediatric wards of one of the research sites
Severe Acute Malnutrition (Weight-for-length z score of less than -3 or mid arm upper circumference of less than 11.5cm, and/or bilateral pedal oedema)
Completed resuscitation phase of nutritional rehabilitation; and clinically stable*
Written, informed consent from the primary caregiver
Caregiver is willing to remain in hospital for the duration of the study treatment (14 days).
*Judged by the medical team on any case-by-case basis, but in general a child without shock, hypothermia, hypoglycaemia or reduced consious level.
Clinically unstable*
Less than 5kg body weight;
Neurological disability which would explain or partly explain poor feeding;
Oro-facial abnormalities which would explain or partly explain poor feeding;
Caregiver unwilling to consent to child HIV testing
Haemoglobin concentration < 6g/dl at the time of enrollment;
Caregiver unwilling to remain in hospital for the duration of the study treatment;
Any underlying condition, other than HIV, which in the opinion of the investigator would put the subject at undue risk of failing study completion or would interfere with analysis of study results;
Contraindication to any of the trial treatments (e.g allergy to cow's milk protein.
*As assesed by the medical team on a case-by-case basis, but in general a clinically unstable child would include shock, hypothermia, hypoglycaemia or reduced consious level.
The primary endpoints for this trial will be measured on day 14 (allowable window 14 to 18 days) after initiating treatment by analysis of faecal biomarkers. Gut inflammation will be measured as a composite score of faecal myeloperoxidase, neopterin and alpha-1 antitrypsin, as outlined in section 13.
9.0 DESIGN OF THE TRIAL
Opened
If controlled
120
225 children in total will be enrolled across Zimbabwe and Zambia (up to 120 in Zimbabwe). Allowing for 20% death/loss to follow-up (see below) we will have 180 evaluable children