Severe Acute MalnutritionNCT03303131
SAM: Discharge Based on the Use of a MUAC-based Criterion to
An observational study of Severe Acute Malnutrition, run by Epicentre.
Trial 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 more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Severe Acute Malnutrition
- What is being tested?
- Discharge from community-based management
- How many people
- 50,841 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2007to 31 Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Study population: All children admitted to the MSF therapeutic feeding program in Yako and Titao districts from September 2007 to December 2011
Who may be able to join
- 6 to 59 months old
- presence of bipedal pitting edema or MUAC ≤ 118 mm
Who cannot join
- < 6 months old or > 59 months old
- absence of bipedal pitting edema or MUAC ≥ 118 mm
About this study
Official title: Discharge From Community-based Management of Severe Acute Malnutrition Using Mid Upper Arm Circumference
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%).
- Conditions
- Severe Acute Malnutrition
- Being tested
- Discharge from community-based management
- Medical subject headings
- Severe Acute Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discharge from community-based managementOther
Comparison of patient characteristics and treatment outcomes between two groups
| Study group | Role | What they receive |
|---|---|---|
| Period A | Children discharged as recovered from September 2007 to March 2009 with at least 15% of their weight at admission Receives: 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 Receives: Other: Discharge from community-based management |
What is being measured
The primary outcome is the main question the study is designed to answer.
MUAC based criterion
Use of a discharge criterion of MUAC ≥ 124 mm
Measured: 52 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start1 Sep 2007
- Primary completion31 Dec 2011
- Study completion31 Dec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 50,841 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epicentre
- Sponsor type
- University, hospital or other
- Collaborators
- Medecins Sans Frontieres, Netherlands
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303131
- Sponsor's protocol ID
- MUAC 2007-2011
- Status last verified
- Jan 2018
- First submitted
- 2 Oct 2017
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discharge From Community-based Management of Severe Acute Malnutrition Using Mid Upper Arm Circumference
- ClinicalTrials.gov ID
- NCT03303131
- Acronym / sponsor ID
- MUAC 2007-2011
- Conditions
- Severe Acute Malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50,841 participants (actual)
- Lead sponsor
- EpicentreUniversity, hospital or other
- Collaborators
- Medecins Sans Frontieres, Netherlands
- Study start
- 1 Sep 2007 (actual)
- Primary completion
- 31 Dec 2011 (actual)
- Study completion
- 31 Dec 2011 (actual)
- First posted
- 5 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period A | – | Other: Discharge from community-based managementChildren discharged as recovered from September 2007 to March 2009 with at least 15% of their weight at admission |
| Period B | – | Other: Discharge from community-based managementChildren discharged as recovered from April 2009 to December 2011 with Children discharged as recovered from September 2007-March 2009 with MUAC ≥ 124 mm |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All children admitted to the MSF therapeutic feeding program in Yako and Titao districts from September 2007 to December 2011
Key inclusion criteria (2 listed)
- 6 to 59 months old
- presence of bipedal pitting edema or MUAC ≤ 118 mm
Key exclusion criteria (2 listed)
- < 6 months old or > 59 months old
- absence of bipedal pitting edema or MUAC ≥ 118 mm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discharge from community-based managementComparison of patient characteristics and treatment outcomes between two groups | Other | Period A, Period B |
Primary outcome
MUAC based criterion
Time frame: 52 months
Use of a discharge criterion of MUAC ≥ 124 mm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Acute Malnutrition, run by Epicentre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MUAC based criterion (time frame: 52 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.