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Smartphone-based bilirubin monitoring for detection of significant hyperbilirubinemia before and after hospital discharge

Smartphone-based bilirubin monitoring for detection of significant hyperbilirubinemia before and after hospital discharge

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20260511006
Enrollment
250
Registered
2026-05-11
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Neonatal jaundice Hyperbilirubinemia Severe neonatal hyperbilirubinemia Neonatal jaundice Hyperbilirubinemia Newborn Smartphone Screening

Interventions

Clinically well neonates with gestational age 35 to 42 weeks and age 1 to 14 days who require bilirubin assessment for neonatal jaundice. All participants will undergo standard bilirubin measurement a
Screening
Neonates requiring bilirubin assessment

Sponsors

Faculty of Medicine Ramathibodi Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 14 Days

Inclusion criteria

Inclusion criteria: 1. Clinically well neonates at GA 35-42 weeks, aged 1-14 days 2. Requiring TSB and/or TcB for evaluation of neonatal jaundice 3. Informed consent obtained

Exclusion criteria

Exclusion criteria: 1. Recent phototherapy or exchange transfusion within 24 hours 2. Abnormal skin lesions at the measurement site 3. Neonatal cholestasis

Design outcomes

Primary

MeasureTime frame
Agreement and Correlation between Smartphone-based bilirubin measurement and Total serum bilirubin At time of bilirubin measurement Bland Altman analysis and correlation coefficient between smartphone based bilirubin measurement and total serum bilirubin

Secondary

MeasureTime frame
Screening performance of smartphone-based bilirubin measurement for clinically significant hyperbilirubinemia At time of bilirubin measurement - Sensitivity, Specificity, Positive predictive value and Negative predictive value for detecting clinically significant hyperbilirubinemia,Agreement and Correlation between Smartphone-based bilirubin measurement and Transcutaneous bilirubin At time of bilirubin measurement Bland Altman analysis and correlation coefficient between smartphone based bilirubin and transcutaneous bilirubin

Countries

Thailand

Contacts

Public ContactVissuta Koyekaewphring

Mahidol University/ Ramathibodi Hospital

vissuta_koy@hotmail.com0841644166

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026