Software based affordable screening for newborns and young childre
Not Applicable
- Registration Number
- CTRI/2022/11/047688
- Lead Sponsor
- Algorithmic Biologics Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Subjects whose Guardians are willing to give written informed consent for study participation
Subjects who are ready to comply with the study related procedures
Exclusion Criteria
Any active illness, psychological and/or pathological condition that would interfere with study participation in the opinion of the Investigator
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity of Tapestry: Sensitivity is defined as 1 minus (the number of samples called positive by the standard of care and called negative by tapestry)/(number of samples called positive by the standard of care) <br/ ><br>and <br/ ><br>Specificity of Tapestry as compared to Specificity of Standard Modalities: Specificity is defined as 1 minus (number of samples called negative by standard of care but called positive by tapestry)/(number of samples called negative by standard of care)Timepoint: The single time point at which the data will be analysed will be 12 weeks from the start of the study.
- Secondary Outcome Measures
Name Time Method Recommend how Tapestry can be used to screen neonates for IEMTimepoint: The time point at which the data will be analysed remains common with that mentioned under primary outcomes, i.e. with the overall data analysis, at 12 weeks from the start of the study.