N/A
N=1,957
Moderate Acute Malnutrition (MAM) and Severe Acute Malnutrition (SAM) in Sierra Leone
Malnutrition
Bottom Line
View on ClinicalTrials.gov: NCT01785680 ↗Enrolled (actual)
1,957
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Recovery Under the Integrated Program and the Standard Protocol — 910; 682 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Integrated Protocol (Other); Current protocol (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recovery Under the Integrated Program and the Standard Protocol |
910; 682 | — |
| SECONDARY Change in Growth Rates |
0.52; 0.25 | — |
| SECONDARY Duration of Treatment |
2.7; 3.5 | — |
| SECONDARY Change in Recovery Status After 12 Weeks |
544; 459 | — |
Summary
The long-term objective of this proposal is to develop and demonstrate an effective, integrated and streamlined protocol to treat moderate acute malnutrition (MAM) and non-complicated severe acute malnutrition (SAM) in children during humanitarian emergencies.
Hypothesis: An integrated management protocol for MAM and SAM will achieve greater community coverage and a greater individual recovery rate than standard care.
Eligibility Criteria
Inclusion Criteria
- Children with MAM or non-complicated SAM aged 6-59 months.
- Have an acceptable appetite.judged by giving the child 30 g of RUTF and asking the mother to feed this food to the child over 20 minutes. Children with SAM who are able to consume this RUTF will be eligible for the study. Children unable to consume the RUTF or presenting with IMCI warning signs (convulsions, altered mental status, respiratory distress) will be considered to have complicated SAM and will be referred for inpatient treatment.
- Only the youngest child with malnutrition in each household will be enrolled; older siblings with MAM or SAM will be treated operationally using the same protocol.
Exclusion Criteria
- Children with obvious chronic debilitating illness like cerebral palsy or congenital abnormalities
- Children having received treatment for MAM or SAM in the previous two months.
Data sourced from ClinicalTrials.gov (NCT01785680). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.