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Evaluation of a Painless Haemoglobin estimation Device for Anaemia Screening in Preschool Children

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 - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/01/100779
Enrollment
590
Registered
2026-01-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil Intervention4: Nil: Nil

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Pre school children aged 3 to 5 years from school settings. 2.Children with written consent obtained from parents or guardians.

Exclusion criteria

Exclusion criteria: 1. Known bleeding disorders 2. Conditions potentially affecting non-invasive hemoglobin accuracy (e.g.,Edema, skin conditions at the sensor site, jaundice, severe dehydration) 3. Presence of cuts, wounds, or henna tattoos on the fingers

Design outcomes

Primary

MeasureTime frame
To generate comparative evidence on the diagnostic accuracy and cost-effectiveness of the non-invasive Masimo Rad-67 versus the minimally invasive POC and the standard haematology analyser for anaemia screening in preschool childrenTimepoint: Baseline—

Secondary

MeasureTime frame
The study will provide insights into operational feasibility, child comfort, acceptability, & the impact of real-time results on referral & caregiver responseTimepoint: Baseline;The findings will inform policy decisions under Anaemia Mukt Bharat & similar programs regarding the integration of point-of-care technologies into early childhood health screening.Timepoint: Baseline—

Countries

India

Contacts

Public ContactDr Sai Ram Challa

ICMR- National Institute of Nutrition (ICMR-NIN)

challa.sv@icmr.gov.in9618774603

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026