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Evaluation of a new jaundice diagnostic device

Minicare Calibration study - NA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/013449
Enrollment
172
Registered
2018-04-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- New Borns with or without jaundice

Interventions

Intervention1: Minicare: Measure the bilirubin value in new born blood Control Intervention1: Unistat: Measure the value of bilirubin in newborn blood

Sponsors

Philips India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All Newborns advised for bilirubin test who are more than 1 kg

Exclusion criteria

Exclusion criteria: 1.Inadequate blood sample 2.Babies given intalipid infusion or Hyperlipidemia sample 3.Neonatal sepsis 4.Neonates who have received blood transfusions 5.Neonates with severe anemia

Design outcomes

Primary

MeasureTime frame
To compare the measurements of bilirubin obtained from Minicare and predicate device â??Unistatâ??.Timepoint: 4 Months—

Secondary

MeasureTime frame
To evaluate the readings of Minicare with labanalyzers that use Diazo method.Timepoint: 2 Months—

Countries

India

Contacts

Public ContactDr Ranjan Pejaver

Kempegowda Institute of Medical Sciences

rpejaver@yahoo.com9845009485

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026