MalnutritionMUAC120NCT03280082
Use of MUAC as Basic Criterion for Admission, Follow-up and Exit From the Ambulatory Nutrition Program
A study testing MUAC Program and Standard Program in people with Malnutrition, run by Epicentre at 1 site in Niger.
Trial summary
The aim of this study is to provide comprehensive documentation of the relevant results and operational implications of this new model using Mid-Upper Arm Circumference (MUAC) as the single anthropometric criterion for admission, monitoring and exit of non- complicated in Niger. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Malnutrition
- What is being tested?
- MUAC Program and Standard Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,200 participants
- Where
- 1 siteNiger
- Study dates
- 25 Jun 2018to 31 Dec 2020
- Phase
- Interventional
- 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
Who may be able to join
- All children admitted for non-complicated SAM (Severe Acute Malnutrition) treatment
Who cannot join
- Children between the ages of 6 and 59 months who were recently excluded from treatment by admission criteria based on MUAC (Sabon Guida site) but were previously eligible for treatment (ie MUAC ≥ 120 and Z score <-3).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Operational Experience for the Use of the Mid-Upper Arm Circumference (MUAC) as the Basic Criterion for Admission, Follow-up and Exit of the Ambulatory Nutrition Program in Two CRENAS, Madaoua District, Niger
The aim of this study is to provide comprehensive documentation of the relevant results and operational implications of this new model using Mid-Upper Arm Circumference (MUAC) as the single anthropometric criterion for admission, monitoring and exit of non- complicated in Niger.
Read the detailed description
This is a first operational experiment using Mid-Upper Arm Circumference (MUAC) as the single anthropometric criterion for the admission, monitoring and exit of the management of uncomplicated SAM (Severe Acute Malnutrition) in Niger, specific data as well as data from routine program will be collected to allow comprehensive documentation of all relevant results and operational implications of this new model. The experiment based on the use of the single anthropometric threshold for admission of a Mid-Upper Arm Circumference (MUAC)<120 mm, which includes both children currently classified as having SAM (currently with PB <115 mm) and acute malnutrition moderate (MAM, currently with a Mid-Upper Arm Circumference (MUAC)<125 mm), as well as a follow-up of children with a Mid-Upper Arm Circumference (MUAC)≥ 120 mm, will identify how children respond to treatment and benefit of the spectrum of acute malnutrition.
- Conditions
- Malnutrition
- Being tested
- MUAC Program, Standard Program
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MUAC ProgramOther
All children admitted to the PB program will receive standard care according to the national Protocol and that of MSF, including preventive and therapeutic care at admission as well as hospital care in case of clinical complications. There will be no change in the Protocol for the hospital care to the CRENI (Center of Intensive Nutritional Rehabilitation). RUTF (Ready-to-Use therapeutic food) will be distributed on a weekly basis according to the dosage of RUTF in the national protocol.
Standard ProgramOther
All children admitted to the standard program will receive standard care according to national and MSF protocols, including preventive and therapeutic care on admission as well as hospital care in case of clinical complications. RUTF will be distributed on a weekly basis according to the dosage of RUTF in the national protocol.
| Study group | Role | What they receive |
|---|---|---|
| MUAC Program | Other | At the CRENAS, MUAC as unique anthropometric criteria for admission, monitoring, and care for the SAM output will be used.
The criteria for admission include:
* MUAC <120 mm
* Bilateral edema of grade + or ++
The criteria for release of care include:
* MUAC ≥ 125 mm at 2 consecutive visits
* Minimum stay 3 weeks in the program
* Absence of acute medical complications
* Absence of edema Receives: Other: MUAC Program |
| Standard Program | Other | Regular screenings in the communities on children between 6 and 59 months of age. Children with MUAC<125 mm will be referred to Nutrition Centers for admission.
The criteria for admission include:
* MUAC<115 mm and/or
* Z score <-3 and /or
* Bilateral edema of grade + or ++
The criteria for release of care include:
* MUAC ≥ 125 mm at 2 consecutive visits
* Minimum stay 3 weeks in the program
* Absence of acute medical complications
* Absence of edema Receives: Other: Standard Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional recovery
Compare the average daily weight gain and the duration of the nutritional treatment per group compare the results of the PB programme, including the overall risk of recovery, transfer, of abandonment, of death, of PB and weight gain and the length of stay by age (6-23 months, compared to 24-59 months), compared the results of the program standard;
Measured: 18 months
Secondary outcomes (2)
Readmission risks
Assessment of the risk of readmission 3 months after discharged of the child will be evaluated at 3 months (+/- one week) after discharged of the child
Measured: 3 months
Deaths
Compare the death rate between the two groups
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start25 Jun 2018
- Primary completion28 Feb 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epicentre
- Sponsor type
- University, hospital or other
- Collaborators
- Medecins Sans Frontieres, Spain, Direction de la Nutrition du Niger, District Sanitaire de Madaoua, Niger, Direction Régionale Sanitaire de Tahoua, Niger
- Responsible party
- Sponsor
- Investigators
- Rebecca GRAIS, PhD, Study director, Epicentre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280082
- Sponsor's protocol ID
- MUAC 120
- Acronym
- MUAC120
- Status last verified
- Feb 2021
- First submitted
- 7 Sep 2017
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Isanaka S, Hedt-Gauthier BL, Grais RF, Allen BGS. Estimating program coverage in the treatment of severe acute malnutrition: a comparative analysis of the validity and operational feasibility of two methods. Popul Health Metr. 2018 Jul 3;16(1):11. doi: 10.1186/s12963-018-0167-3.
PubMed 29970172
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operational Experience for the Use of the Mid-Upper Arm Circumference (MUAC) as the Basic Criterion for Admission, Follow-up and Exit of the Ambulatory Nutrition Program in Two CRENAS, Madaoua District, Niger
- ClinicalTrials.gov ID
- NCT03280082
- Acronym / sponsor ID
- MUAC120 / MUAC 120
- Conditions
- Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,200 participants (actual)
- Lead sponsor
- EpicentreUniversity, hospital or other
- Collaborators
- Medecins Sans Frontieres, Spain, Direction de la Nutrition du Niger, District Sanitaire de Madaoua, Niger, Direction Régionale Sanitaire de Tahoua, Niger
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 12 Sep 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.
The aim of this study is to provide comprehensive documentation of the relevant results and operational implications of this new model using Mid-Upper Arm Circumference (MUAC) as the single anthropometric criterion for admission, monitoring and exit of non- complicated in Niger.
Detailed description
This is a first operational experiment using Mid-Upper Arm Circumference (MUAC) as the single anthropometric criterion for the admission, monitoring and exit of the management of uncomplicated SAM (Severe Acute Malnutrition) in Niger, specific data as well as data from routine program will be collected to allow comprehensive documentation of all relevant results and operational implications of this new model. The experiment based on the use of the single anthropometric threshold for admission of a Mid-Upper Arm Circumference (MUAC)<120 mm, which includes both children currently classified as having SAM (currently with PB <115 mm) and acute malnutrition moderate (MAM, currently with a Mid-Upper Arm Circumference (MUAC)<125 mm), as well as a follow-up of children with a Mid-Upper Arm Circumference (MUAC)≥ 120 mm, will identify how children respond to treatment and benefit of the spectrum of acute malnutrition.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MUAC Program | Other | Other: MUAC ProgramAt the CRENAS, MUAC as unique anthropometric criteria for admission, monitoring, and care for the SAM output will be used. The criteria for admission include: * MUAC <120 mm * Bilateral edema of grade + or ++ The criteria for release of care include: * MUAC ≥ 125 mm at 2 consecutive visits * Minimum stay 3 weeks in the program * Absence of acute medical complications * Absence of edema |
| Standard Program | Other | Other: Standard ProgramRegular screenings in the communities on children between 6 and 59 months of age. Children with MUAC<125 mm will be referred to Nutrition Centers for admission. The criteria for admission include: * MUAC<115 mm and/or * Z score <-3 and /or * Bilateral edema of grade + or ++ The criteria for release of care include: * MUAC ≥ 125 mm at 2 consecutive visits * Minimum stay 3 weeks in the program * Absence of acute medical complications * Absence of edema |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children admitted for non-complicated SAM (Severe Acute Malnutrition) treatment
Key exclusion criteria (1 listed)
- Children between the ages of 6 and 59 months who were recently excluded from treatment by admission criteria based on MUAC (Sabon Guida site) but were previously eligible for treatment (ie MUAC ≥ 120 and Z score <-3).
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 |
|---|---|---|
| MUAC ProgramAll children admitted to the PB program will receive standard care according to the national Protocol and that of MSF, including preventive and therapeutic care at admission as well as hospital care in case of clinical complications. There will be no change in the Protocol for the hospital care to the CRENI (Center of Intensive Nutritional Rehabilitation). RUTF (Ready-to-Use therapeutic food) will be distributed on a weekly basis according to the dosage of RUTF in the national protocol. | Other | MUAC Program |
| Standard ProgramAll children admitted to the standard program will receive standard care according to national and MSF protocols, including preventive and therapeutic care on admission as well as hospital care in case of clinical complications. RUTF will be distributed on a weekly basis according to the dosage of RUTF in the national protocol. | Other | Standard Program |
Primary outcome
Nutritional recovery
Time frame: 18 months
Compare the average daily weight gain and the duration of the nutritional treatment per group compare the results of the PB programme, including the overall risk of recovery, transfer, of abandonment, of death, of PB and weight gain and the length of stay by age (6-23 months, compared to 24-59 months), compared the results of the program standard;
2 secondary outcomes
Readmission risks
Time frame: 3 months
Deaths
Time frame: 18 months
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 10 Feb 2021.
- Derived from this study: PubMed 29970172Isanaka S, Hedt-Gauthier BL, Grais RF, Allen BGS. Estimating program coverage in the treatment of severe acute malnutrition: a comparative analysis of the validity and operational feasibility of two methods. Popul Health Metr. 2018 Jul 3;16(1):11. doi: 10.1186/s12963-018-0167-3.
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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.
Rebecca GRAIS, PhD study director
Epicentre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MUAC Program and Standard Program in people with Malnutrition, run by Epicentre at 1 site in Niger.
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 1 inclusion and 1 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 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Niger. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Nutritional recovery (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03280082, which also lists 1 linked publication.
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 10 Feb 2021; AzTrials last refreshed its copy on 6 Nov 2026.