Evaluation of Hemoglobin Measurement Tools for Child Anemia Screening in Rwanda
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Pronto® Hb measurement
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Pronto® Hb measurement
时间窗: 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.
次要结局
- HemoCue® Hb measurement(Day 1)