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Evaluation of Hemoglobin Measurement Tools for Child Anemia Screening in Rwanda

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02603250
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : January 8, 2016
Sponsor:
Collaborator:
University of Rwanda
Information provided by (Responsible Party):
PATH

Brief 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.


Condition or disease
Anemia

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Study Type : Observational
Actual Enrollment : 132 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Evaluation of Hemoglobin Measurement Tools for Child Anemia Screening in Rwanda
Study Start Date : September 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Group/Cohort
Wicking
50% of the 132 children enrolled in the study will have their Hb measured using the wicking method of HemoCue® 201+ blood collection.
Gravity
50% of the 132 children enrolled in the study will have their Hb measured using the gravity method of HemoCue® 201+ blood collection.



Primary Outcome Measures :
  1. Pronto® Hb measurement [ Time Frame: Day 1 ]
    Average difference (correlation and concordance) between Hb measurements obtained using the Pronto® with DCI-mini™ sensors and the standard reference hematology analyzer, and t-test statistic.


Secondary Outcome Measures :
  1. HemoCue® Hb measurement [ Time Frame: Day 1 ]
    Average difference (correlation and concordance) between each of the HemoCue® Hb 201+ capillary blood collection methods and the standard reference hematology analyzer, and t-test statistic.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants will be children 6 to 59 months of age, receiving outpatient care from Centre Hospitalier Universitaire de Kigali (CHUK) and providing a venous blood sample for their health care.
Criteria

Inclusion Criteria:

  • Children, 6 to 59 months of age, receiving outpatient health care from CHUK who will already be providing a venous blood sample for their care. Outpatients typically receive care for upper respiratory infections, pneumonia, malaria, HIV infection, allergies, simple diarrhea, ear infection, malnutrition, and chronic fever. Children experiencing these health issues can be included in the sample. Children experiencing more mild health issues will also be included in the sample.
  • Ability and willingness of study participant's parent/legal guardian to provide informed consent.
  • Giving a venous blood sample for Hb measurement as part of their standard of care.

Exclusion Criteria:

  • Younger than 6 months of age.
  • Older than 59 months of age.
  • Weight less than 3 kg.
  • Weight greater than 30 kg.
  • Any medical condition that would interfere with participant's ability to participate in the study. Such medical conditions include trauma, dehydration, shock, and all acute illnesses requiring urgent care.
  • Skin abnormalities (e.g., burns, scar tissue, infections) at the planned application sites that would interfere with or preclude sensor placement and ability to transluminate the finger.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603250


Locations
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Rwanda
Centre Hospitalier Universitaire de Kigali
Kigali, Rwanda
Sponsors and Collaborators
PATH
University of Rwanda
Investigators
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Principal Investigator: Megan E Parker, MSc, PhD PATH
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Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT02603250    
Other Study ID Numbers: 703581-3
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: September 2015
Keywords provided by PATH:
Anemia
Iron deficiency
noninvasive anemia screening
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases