HIV/AIDS Neonatal Diseases Nutritional, Metabolic, Endocrine
Conditions
Interventions
Arm 1 Standard of Care Control
Arm 2 Antimicrobial
Arm 3 Psychosocial Support
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 6-59 months, of either sex 2. Hospitalised with complicated severe acute malnutrition, as per WHO definitiona 3. Started transition from therapeutic milk feeds to RUTF 4. Caregiver willing and able to attend the study clinic for all visits 5. Caregiver able and willing to give informed consent
Exclusion criteria
Exclusion criteria: 1. Any acute or chronic condition which mean that receipt of one or more study interventions, or participation in the trial, would not be advisable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A composite of death or hospitalisation or failed nutritional recovery | — |
Secondary
| Measure | Time frame |
|---|---|
| • Change in weight-for-height Z-score between baseline and 24 weeks postrandomisation • Change in mid-upper arm circumference between baseline and 24 weeks postrandomisation • Change in weight-for-age Z-score between baseline and 24 weeks postrandomisation • Change in height-for-age Z-score between baseline and 24 weeks postrandomisation • Suspected or confirmed tuberculosis, pneumonia, diarrhoea, or malaria through 24 weeks post-randomisation | — |
Countries
Kenya, Zambia, Zimbabwe
Contacts
Public ContactAaron Konzani Tembo
Clinical Research and Compliance Manager at TROPGAN
Outcome results
None listed