Improving the treatment of severe acute malnutrition in childhood: a randomized controlled trial of synbiotic-enhanced therapeutic food with long term follow-up of post-treatment mortality and morbidity.
Doctoral thesis, UCL (University College London).
BACKGROUND: Tackling severe acute malnutrition (SAM) is a global public health priority. This thesis explores two major influences on treatment outcomes: -Treatment efficacy -Patient-related risk factors OBJECTIVES: 1. To explore whether a pre/probiotic mixture (Synbiotic2000 Forte™) improves treatment outcomes (nutritional and clinical) in children affected by SAM. 2. To describe long term outcomes from SAM and identify key mortality risk factors. METHODS: All 1024 malnourished children admitted to a therapeutic feeding centre in Malawi from July 2006 to March 2007 were eligible for: The PRONUT study (Pre and PRObiotics in the treatment of severe acute malNUTrition): 795 were recruited into a randomised, double-blind, placebo-controlled trial. They received Readyto- Use Therapeutic Food either with or without Synbiotic2000 Forte™. Primary outcome was nutritional cure (weight-for-height >80% of NCHS median). The FUSAM study (Long term Follow-Up after Severe Acute Malnutrition): all children known to be still alive were followed up ≥1 year post discharge. RESULTS: In PRONUT, nutritional cure was similar in both groups: 54%(215/399) for Synbiotic-enhanced RUTF and 51%(203/396) for controls (p=0.40). Main secondary outcomes were also similar (p>0.05). Overall mortality from SAM was 41%(427/1024). Mortality was highest during initial inpatient treatment: 23%(238/1024). In FUSAM, 8%(84/1024) more died within 90 days of admission and 10%(105/1024) during long term follow-up. Cox regression identified HIV, low weight-forheight, low mid-upper arm circumference and low weight-for-age as major risk factors for death (p<0.001). CONCLUSIONS: In this high-mortality setting, Synbiotic2000 ForteTM, did not improve clinical or nutritional outcomes from SAM. A more promising strategy to improve outcomes might be to tackle the major risk factors for SAM mortality: HIV and severity of malnutrition disease. It is likely that earlier treatment would be beneficial. This is a focus of current strategies for both HIV and malnutrition. Rollout of such programmes should be supported and their impact on SAM evaluated.
|Title:||Improving the treatment of severe acute malnutrition in childhood: a randomized controlled trial of synbiotic-enhanced therapeutic food with long term follow-up of post-treatment mortality and morbidity|
|Open access status:||An open access version is available from UCL Discovery|
|Additional information:||Pages 200-218 of the digital copy of this thesis have been removed for copyright reasons|
|UCL classification:||UCL > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute of Child Health > Department of Population Health Sciences > ICH - Centre for International Health and Development|
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