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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01790815
Other study ID # MUAC mères
Secondary ID
Status Completed
Phase N/A
First received February 12, 2013
Last updated December 8, 2013
Start date August 2011
Est. completion date August 2012

Study information

Verified date December 2013
Source Alliance for International Medical Action
Contact n/a
Is FDA regulated No
Health authority Niger: Institutional Review Board
Study type Observational

Clinical Trial Summary

PRIMARY OBJECTIVE :

To determine whether mothers, given minimal group training, are capable of using a MUAC (mid-upper arm circumference) bracelet to screen their children for malnutrition and categorise them into one of three groups : 'red' (SAM ; severe acute malnutrition), 'yellow' (MAM ; moderate acute malnutrition) or 'green' (normal nutritional status)

SECONDARY OBJECTIVES :

To establish whether there is a difference in the MUAC value if measured on the right arm as opposed to the left, in young children

To determine whether there is a difference in the MUAC value if the mid upper arm position is determined visually as opposed to being measured in the 'classical' fashion


Description:

Severe Acute Malnutrition (SAM) and its complications are major causes of death in under 5s in the developing world. A simple, reproducible, scalable way to recognise acute malnutrition and target early intervention would be a huge advance. Can mothers with limited training reliably measure and interpret the results of Mid Upper Arm Circumference (MUAC), a measurement performed with a MUAC measuring tape costing $0.06? MUAC contrasts with Z-score (WHZ), which requires both scales and a height gauge, both health worker interventions susceptible to considerable error, sensitive to non-nutritional factors, requiring calculations and growth curves, yet much less accurate in predicting risk of death compared with MUAC.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Months to 59 Months
Eligibility Inclusion Criteria:

- children present in the inpatient malnutrition treatment unit and paediatric service of the Mirriah district hospital aged between 6-59 months old

- children aged between 6-59 months old in the two villages where the community phase of the study was conducted

Exclusion Criteria:

- children receiving treatment in the intensive care unit of Mirriah district hospital

- children with bilateral oedema

- children whose mothers or fathers refused consent to participate in the study

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Niger Mirriah Health District Mirria Mirriah

Sponsors (2)

Lead Sponsor Collaborator
Alliance for International Medical Action Bien Être de La femme et de L'Enfant au Niger

Country where clinical trial is conducted

Niger, 

References & Publications (2)

Briend A, Garenne M, Maire B, Fontaine O, Dieng K. Nutritional status, age and survival: the muscle mass hypothesis. Eur J Clin Nutr. 1989 Oct;43(10):715-26. — View Citation

Briend A, Maire B, Fontaine O, Garenne M. Mid-upper arm circumference and weight-for-height to identify high-risk malnourished under-five children. Matern Child Nutr. 2012 Jan;8(1):130-3. doi: 10.1111/j.1740-8709.2011.00340.x. Epub 2011 Sep 28. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary inter and intra observer variability Variance in result of screening for malnutrition performed by mothers with minimal training compared to 'gold-standard' fully trained health care workers. Screening will be performed with a MUAC (mid-upper arm circumference) bracelet, results will be expressed by category: SAM (severe acute malnutrition), MAM (moderate acute malnutrition) or 'normal nutritional status 2 years No
Secondary inter and intra observer variability The difference in millimetres in the MUAC value if measured on the right arm as opposed to the left ('classical method'), in young children 2 years No
Secondary inter and intra observer variability The difference in the MUAC value in millimetres if the mid upper arm position is determined visually as opposed to being measured in the 'classical' fashion 2 years No
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