NCT06545240

Brief Summary

WHO recommends 11.5 cm as a cut-off point of Mid-Upper Arm Circumference (MUAC) to detect and/or diagnose severe acute malnutrition (SAM) in under-five. MUAC is practical and useful, especially in area with limited facilities which has no standardized scale and infantometer. However, several studies showed that this cut-off need to be evaluated as it has modest detection rate for SAM. This study aims to evaluate diagnostic value of MUAC with 11.5 cm cut-off compared to WHZ as gold standard to identify SAM. The sensitivity, specificity, positive and negative predictive value of MUAC with 11.5 cm as a standard cut-off will be evaluated. This study also aim to find new cut-off value that may offer better diagnostic performance. The main research questions were: What is the diagnostic accuracy of Mid-Upper Arm Circumference (MUAC) compared to the Weight for Height Z Score (WHZ) in identifying SAM in children, and what is the optimal MUAC cut-off value for enhanced diagnostic performance?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
421

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2020

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

July 31, 2024

Last Update Submit

August 6, 2024

Conditions

Keywords

mid-upper arm circumferencesensitivitysevere acute malnutritionspecificityWHZ index

Outcome Measures

Primary Outcomes (1)

  • Diagnostic value of MUAC in diagnosing SAM compare to WHZ-index

    To evaluate sensitivity, specificity, positive and negative predictive value of MUAC

    2 months

Secondary Outcomes (1)

  • Finding new cut off value that offer better diagnostic performance using ROC

    2 months

Interventions

Mid-upper arm circumference was taken using non-stretchable band SECA 202

Also known as: Weight measurement, Length and height measurement

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

This study was conducted in the largest primary community health care facility in Cengkareng Jakarta and have 29.110 registered under-fives in its service area.

You may qualify if:

  • under-fives that 6-59 months-old

You may not qualify if:

  • ascites
  • edema
  • hydrocephalus
  • tumor or oncologic diseases
  • organomegaly
  • uncooperative during measurement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Puskesmas Cengkareng

Jakarta, DKI Jakarta, 11730, Indonesia

Location

RSUPN Dr Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10440, Indonesia

Location

MeSH Terms

Conditions

Severe Acute MalnutritionHypersensitivity

Condition Hierarchy (Ancestors)

MalnutritionNutrition DisordersNutritional and Metabolic DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 31, 2024

First Posted

August 9, 2024

Study Start

January 1, 2020

Primary Completion

February 29, 2020

Study Completion

February 29, 2020

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations