| CTRI Number |
CTRI/2026/01/100779 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross sectional diagnostic accuracy study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of a Painless Haemoglobin estimation Device for Anaemia Screening in Preschool Children |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr B Santosh Kumar |
| Designation |
Scientist- E (Medical) |
| Affiliation |
ICMR- National Institute of Nutrition (ICMR-NIN) |
| Address |
Division of Maternal and Child Health and Nutrition ICMR- National Institute of Nutrition (ICMR-NIN) Department of Health Research (DHR),Jamia-Osmania PO, Tarnaka, Hyderabad, Telangana, India
Hyderabad
TELANGANA
500007
India |
| Phone |
9885767609 |
| Fax |
|
| Email |
drsantoshkumar999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sai Ram Challa |
| Designation |
Scientist E (Medical) Head of Division of Maternal and Child Health & Nutrition |
| Affiliation |
ICMR- National Institute of Nutrition (ICMR-NIN) |
| Address |
Division of Maternal and Child Health and Nutrition ICMR- National Institute of Nutrition (ICMR-NIN) Department of Health Research (DHR),Jamia-Osmania PO, Tarnaka, Hyderabad, Telangana, India
Hyderabad
TELANGANA
500007
India |
| Phone |
9618774603 |
| Fax |
|
| Email |
challa.sv@icmr.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sai Ram Challa |
| Designation |
Scientist E (Medical) Head of Division of Maternal and Child Health & Nutrition |
| Affiliation |
ICMR- National Institute of Nutrition (ICMR-NIN) |
| Address |
Division of Maternal and Child Health and Nutrition ICMR- National Institute of Nutrition (ICMR-NIN) Department of Health Research (DHR),Jamia-Osmania PO, Tarnaka, Hyderabad, Telangana, India
Hyderabad
TELANGANA
500007
India |
| Phone |
9618774603 |
| Fax |
|
| Email |
challa.sv@icmr.gov.in |
|
|
Source of Monetary or Material Support
|
| National Institute of Nutrition (NIN) Beside Tarnaka Metro station, Jamia-Osmania PO, Hyderabad- 500007, Telangana, India. |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
Indian Council of Medical Research
Ansari Nagar, New Delhi-110029 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr B Santosh Kumar |
Pre schools/Anganwadis |
Tarnaka
Hyderabad
TELANGANA |
9885767609
drsantoshkumar999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Nutrition ICMR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Anemia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
1.Pre school children aged 3 to 5 years from school settings.
2.Children with written consent obtained from parents or guardians. |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 children |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study will provide insights into operational feasibility, child comfort, acceptability, & the impact of real-time results on referral & caregiver response |
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. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="590"
Sample Size from India="590"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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.
|