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Evaluation of Hemoglobin Measurement Tools for Child Anemia Screening in Rwanda

NCT02603250 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 132

Last updated 2016-01-08

No results posted yet for this study

Summary

The purpose of this study is to evaluate the use of a noninvasive Hb device (Pronto® with DCI-mini™ sensors) as an accurate method for measuring Hb levels among children between 6 and 59 months against the standard reference hematology analyzer. The secondary purpose is to evaluate the accuracy of two HemoCue® Hb 201+ capillary blood collection methods against the standard reference hematology analyzer.

The study hypothesizes that the Pronto® with DCI-mini™ sensor will approximate Hb values within ±1.0 g/dL and secondly, it will correctly classify participants as anemic or not anemic with less than 31% disagreement when compared to the standard reference hematology analyzer among children 6 to 59 months of age. Additionally, the two different HemoCue® Hb 201+ capillary blood collection methodologies will both approximate Hb values within ±1.0 g/dL and secondly, it will correctly classify participants as anemic or not anemic with less than 35% disagreement when compared to the standard reference hematology analyzer among children 6 to 59 months of age.

Conditions

Sponsors & Collaborators

  • University of Rwanda

    collaborator OTHER

  • PATH

    lead OTHER

Principal Investigators

  • Megan E Parker, MSc, PhD · PATH

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Rwanda

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02603250 on ClinicalTrials.gov