Validation and Cost-Effectiveness Assessment of a Non-invasive Haemoglobin Estimation Device Against a Program-Used Minimally Invasive Point-of-Care Haemoglobin Device and a Standard Haematology Analyzer for Anaemia Screening in Preschool Settings
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 590
- 试验地点
- 1
研究概览
简要总结
Accurate haemoglobin measurement is essential for diagnosing and managing anaemia in preschool children as part of Test, Treat and Track approach in AMB 2.0, where anaemia rates are reported to be as high as 67% (NFHS 5). While haematology auto analyzers are the gold standard, they are invasive, time-consuming, and impractical for field-level screening. Non-invasive Point-of-care (POC) device such as the Masimo Rad-67 offer a potentially scalable alternative, but its accuracy, feasibility, and cost-effectiveness in comparison with currently used minimally invasive POC devices in program (like HemoCue Hb 201+) and standard haematology analyser in preschool settings remain under-evaluated.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 3.00 Year(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Pre school children aged 3 to 5 years from school settings.
- •2.Children with written consent obtained from parents or guardians.
排除标准
- •Known bleeding disorders
- •Conditions potentially affecting non-invasive hemoglobin accuracy (e.g.,Edema, skin conditions at the sensor site, jaundice, severe dehydration)
- •Presence of cuts, wounds, or henna tattoos on the fingers.
研究者
Dr B Santosh Kumar
ICMR- National Institute of Nutrition (ICMR-NIN)