- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03303131
SAM: Discharge Based on the Use of a MUAC-based Criterion to
Discharge From Community-based Management of Severe Acute Malnutrition Using Mid Upper Arm Circumference
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Comparison of patient characteristics and treatment outcomes was conducted between two groups: 1) children discharged as recovered from September 2007 to March 2009 with at least 15% of their weight at admission (Period A); and 2) children discharged as recovered from April 2009 to December 2011 with MUAC ≥ 124 mm (Period B).
A total of 50,841 children were admitted with MUAC ≤ 118 mm to the MSF therapeutic feeding program and were included in this analysis: 24,792 children in Period A (2007-2009) and 26,049 children in Period B (2009-2011).
Overall, 89% of admissions were directly into outpatient care and the majority (53%) entered with a MUAC 116-118mm; 48% of children were male and 80% of children < 2 years of age (Table 1).
Compared to children admitted in Period A, children admitted in Period B were statistically more likely to be female, younger, and of better anthropometric status (e.g. higher mean MUAC, WHZ and HAZ).
There was a greater proportion of children admitted directly to inpatient care in Period B than in Period A (10.6% vs 8.0%).
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 6 to 59 months old
- presence of bipedal pitting edema or MUAC ≤ 118 mm
Exclusion Criteria:
- < 6 months old or > 59 months old
- absence of bipedal pitting edema or MUAC ≥ 118 mm
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Period A
Children discharged as recovered from September 2007 to March 2009 with at least 15% of their weight at admission
|
Comparison of patient characteristics and treatment outcomes between two groups
|
Period B
Children discharged as recovered from April 2009 to December 2011 with Children discharged as recovered from September 2007-March 2009 with MUAC ≥ 124 mm
|
Comparison of patient characteristics and treatment outcomes between two groups
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MUAC based criterion
Time Frame: 52 months
|
Use of a discharge criterion of MUAC ≥ 124 mm
|
52 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MUAC 2007-2011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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