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CompletedNCT03303131Updated Feb 5, 2018

SAM: Discharge Based on the Use of a MUAC-based Criterion to

An observational study in Severe Acute Malnutrition, sponsored by Epicentre. Completed. Open to participants aged 6 Months to 59 Months. Per ClinicalTrials.gov, last updated 2018-02-05.

Sponsored by Epicentre · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Retrospective
Enrollment
50,841
Ages
6 Months to 59 Months
Sex
All
01

Study summary

Retrospective analysis of routine program data of children aged 6 to 59 months admitted to the MSF therapeutic feeding program with MUAC ≤ 118 mm in Yako and Titao districts of Burkina Faso from 2007-2011.

Read the 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%).

02

Conditions studied

  • Severe Acute Malnutrition
03

Who can participate

Ages eligible
6 Months to 59 Months
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All children admitted to the MSF therapeutic feeding program in Yako and Titao districts from September 2007 to December 2011

Inclusion criteria

  • 6 to 59 months old
  • presence of bipedal pitting edema or MUAC ≤ 118 mm

Exclusion criteria

Exclusion Criteria:

  • \< 6 months old or > 59 months old
  • absence of bipedal pitting edema or MUAC ≥ 118 mm
04

Study design

Observational model
Ecologic or community
Time perspective
Retrospective
Enrollment
50,841 participants (actual)
Patient registry
No

Groups and cohorts

  • Period A

    Children discharged as recovered from September 2007 to March 2009 with at least 15% of their weight at admission

    Other: Discharge from community-based management

  • 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

    Other: Discharge from community-based management

Interventions

  • OtherDischarge from community-based management

    Comparison of patient characteristics and treatment outcomes between two groups

05

What researchers measure

Primary outcomes

  1. MUAC based criterion

    Use of a discharge criterion of MUAC ≥ 124 mm

    Time frame: 52 months

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03303131
Lead sponsor
Epicentre
Collaborators
Medecins Sans Frontieres, Netherlands
Responsible party
Sponsor
First posted
Oct 5, 2017
Start date
Sep 1, 2007
Primary completion
Dec 31, 2011
Completion
Dec 31, 2011
Last update
Feb 5, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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