AnemiaNCT02603250
Evaluation of Hemoglobin Measurement Tools for Child Anemia Screening in Rwanda
An observational study of Anemia, run by PATH at 1 site in Rwanda.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Anemia
- How many people
- 132 participants
- Where
- 1 siteRwanda
- Study dates
- Sep 2015to Dec 2015
- Phase
- Observational
- 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
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The Hb values of 132 children, between 6 and 59 months of age will be obtained, using three different Hb assessment methods during the same assessment visit for comparison with the standard reference hematology analyzer(Sysmex KN21) results.
The purpose of the research is: 1) To evaluate the accuracy of the noninvasive Masmio Pronto® device with DCI-mini sensor in measuring Hb when compared to measuring Hb using the standard reference hematology analyzer, and 2) To evaluate the accuracy of both the HemoCue® Hb 201+ gravity and wicking methodologies of capillary blood collection against the standard reference hematology analyzer.
To validate and determine the accuracy of the Pronto® with DCI-mini™ sensor, the 132 Pronto® Hb values will be compared to the Hb values obtained by the standard reference hematology analyzer to determine if the overall average difference between measurements does not exceed 1.0g/dL.
To validate and determine the accuracy of each of the two HemoCue® 201+ blood collection methods, 50% of the children will have their Hb measured using the wicking method and 50% will have their Hb measured using the gravity method. The Hb values obtained by the two different HemoCue® 201+ blood collection methods will be compared to the standard reference hematology analyzer to determine if the overall average difference between each method and the standard reference is within 1.0g/dL.
For each child, study nurse/coordinator will: collect health information from the child, categorize skin pigmentation using the Massey and Martin NIS Skin Color Scale, measure and record finger diameter using the Masimo finger measuring tool (if none of the fingers are the appropriate size for the sensor, then the big toe will be measured and used instead). Capillary blood samples of the children will be taken via finger pricking of the third or fourth digit. If a child of 6-11 months is acutely malnourished (as determined by their weight-for-height Z score), the blood drop will be obtained from their heel in accordance with Hemocue® 201+ protocol and to ensure the finger bone is not injured due to insufficient finger padding. For both blood sampling locations, the first two drops of blood will be wiped away and only the third blood drop will be used. The randomization process and the data analysis phase will not be blinded.
To determine the accuracy of the noninvasive device, the difference between Hb values obtained from the Pronto® with DCI-mini™ sensory and standard reference hematology analyzer (Sysmex KN21™) will be calculated for each child and an average obtained. In addition to the mean difference (bias), the standard deviation, 95% confidence interval, range, and limits of agreement will also be obtained. Accuracy of Hb measurement by the noninvasive device will be assessed by determining whether the measurement obtained with each noninvasive device falls within ±1.0 g/dL of the standard reference. With 100 samples and assuming the correlation between measurement methods is at least 0.93, we have 97-99% power to confirm that the average difference between the two Hb measurement methods does not exceed 1.0 g/dL. This analysis will be conducted using a paired t-test since we will be testing a limit on the difference between the measures. The prevalence rate of anemia will also be estimated for the group from the noninvasive measurements in comparison to the standard reference measurements and analyzed by paired t-test. For this comparison, our sample size of 100 affords us enough power to determine if participants are correctly classified as anemic or not anemic, with less than 31% disagreement.
A similar process will be followed for each of the two HemoCue® Hb 201+ capillary blood collection methodologies in comparison to the standard reference hematology analyzer using a paired t-test to test the limit on the difference between measures. With 50 samples and assuming the correlation between measurement methods is at least 0.93, we again have 77-99% power to confirm that the average difference between each of the two Hb measurement methods and the standard reference does not exceed 1.0 g/dL. The prevalence rate of anemia will also be estimated for each of the HemoCue® 201+ study arms for comparison with the standard reference measurements and analyzed by paired t-test. For this comparison, our sample size of 100 enables us to test if participants are correctly classified as anemic or not anemic, with less than 35% disagreement.
- Conditions
- Anemia
- Keywords
- Anemia, Iron deficiency, noninvasive anemia screening
- Medical subject headings
- Anemia, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pronto® Hb measurement
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.
Measured: Day 1
Secondary outcomes (1)
HemoCue® Hb measurement
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rwanda
- Responsible party
- Sponsor
- Investigators
- Megan E Parker, MSc, PhD, Principal investigator, PATH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603250
- Sponsor's protocol ID
- 703581-3
- Status last verified
- Sep 2015
- First submitted
- 9 Nov 2015
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hemoglobin Measurement Tools for Child Anemia Screening in Rwanda
- ClinicalTrials.gov ID
- NCT02603250
- Acronym / sponsor ID
- 703581-3
- Conditions
- Anemia
- Keywords
- Anemia, Iron deficiency, noninvasive anemia screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- University of Rwanda
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Nov 2015 (estimated)
- 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 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.
Detailed description
The Hb values of 132 children, between 6 and 59 months of age will be obtained, using three different Hb assessment methods during the same assessment visit for comparison with the standard reference hematology analyzer(Sysmex KN21) results.
The purpose of the research is: 1) To evaluate the accuracy of the noninvasive Masmio Pronto® device with DCI-mini sensor in measuring Hb when compared to measuring Hb using the standard reference hematology analyzer, and 2) To evaluate the accuracy of both the HemoCue® Hb 201+ gravity and wicking methodologies of capillary blood collection against the standard reference hematology analyzer.
To validate and determine the accuracy of the Pronto® with DCI-mini™ sensor, the 132 Pronto® Hb values will be compared to the Hb values obtained by the standard reference hematology analyzer to determine if the overall average difference between measurements does not exceed 1.0g/dL.
To validate and determine the accuracy of each of the two HemoCue® 201+ blood collection methods, 50% of the children will have their Hb measured using the wicking method and 50% will have their Hb measured using the gravity method. The Hb values obtained by the two different HemoCue® 201+ blood collection methods will be compared to the standard reference hematology analyzer to determine if the overall average difference between each method and the standard reference is within 1.0g/dL.
For each child, study nurse/coordinator will: collect health information from the child, categorize skin pigmentation using the Massey and Martin NIS Skin Color Scale, measure and record finger diameter using the Masimo finger measuring tool (if none of the fingers are the appropriate size for the sensor, then the big toe will be measured and used instead). Capillary blood samples of the children will be taken via finger pricking of the third or fourth digit. If a child of 6-11 months is acutely malnourished (as determined by their weight-for-height Z score), the blood drop will be obtained from their heel in accordance with Hemocue® 201+ protocol and to ensure the finger bone is not injured due to insufficient finger padding. For both blood sampling locations, the first two drops of blood will be wiped away and only the third blood drop will be used. The randomization process and the data analysis phase will not be blinded.
To determine the accuracy of the noninvasive device, the difference between Hb values obtained from the Pronto® with DCI-mini™ sensory and standard reference hematology analyzer (Sysmex KN21™) will be calculated for each child and an average obtained. In addition to the mean difference (bias), the standard deviation, 95% confidence interval, range, and limits of agreement will also be obtained. Accuracy of Hb measurement by the noninvasive device will be assessed by determining whether the measurement obtained with each noninvasive device falls within ±1.0 g/dL of the standard reference. With 100 samples and assuming the correlation between measurement methods is at least 0.93, we have 97-99% power to confirm that the average difference between the two Hb measurement methods does not exceed 1.0 g/dL. This analysis will be conducted using a paired t-test since we will be testing a limit on the difference between the measures. The prevalence rate of anemia will also be estimated for the group from the noninvasive measurements in comparison to the standard reference measurements and analyzed by paired t-test. For this comparison, our sample size of 100 affords us enough power to determine if participants are correctly classified as anemic or not anemic, with less than 31% disagreement.
A similar process will be followed for each of the two HemoCue® Hb 201+ capillary blood collection methodologies in comparison to the standard reference hematology analyzer using a paired t-test to test the limit on the difference between measures. With 50 samples and assuming the correlation between measurement methods is at least 0.93, we again have 77-99% power to confirm that the average difference between each of the two Hb measurement methods and the standard reference does not exceed 1.0 g/dL. The prevalence rate of anemia will also be estimated for each of the HemoCue® 201+ study arms for comparison with the standard reference measurements and analyzed by paired t-test. For this comparison, our sample size of 100 enables us to test if participants are correctly classified as anemic or not anemic, with less than 35% disagreement.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
HemoCue® Hb measurement
Time frame: Day 1
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 8 Jan 2016.
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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.
Megan E Parker, MSc, PhD principal investigator
PATH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, run by PATH at 1 site in Rwanda.
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 3 inclusion and 6 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 8 Jan 2016. 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 Rwanda. 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?
Pronto® Hb measurement (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2016.