Using a smartphone app to detect jaundice in newborns in Botswana
Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Population in Botswana
This study tests if a smartphone app can accurately detect jaundice in newborns, no matter their skin color, by comparing its results to regular blood tests.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 24 Hours to 14 Days |
| Sex | All |
| Sponsor | Hillerod Hospital, Denmark Academic / other |
| Locations | 1 site (Gaborone) |
| Trial ID | NCT06399146 on ClinicalTrials.gov |
What this trial studies
This project evaluates the effectiveness of the Picterus smartphone application for detecting neonatal jaundice in newborns. The study will collect data from infants with varying bilirubin levels and high melanin content at Princess Marina Hospital in Botswana. By comparing the app's bilirubin estimates to traditional blood sample measurements, the researchers aim to demonstrate that this method can accurately identify severe jaundice regardless of skin color. The study employs a diagnostic accuracy cross-sectional design with quantitative data collection methods.
Who should consider this trial
Good fit: Ideal candidates include newborns over 24 hours and under 14 days old, with a gestational age greater than 37 weeks and a birth weight between 2000 g and 4500 g.
Not a fit: Patients who have been transferred for advanced treatment, have skin conditions affecting measurement, or have received recent phototherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this app could provide a cost-effective and accessible way to detect neonatal jaundice, potentially reducing the risk of serious complications.
How similar studies have performed: While the use of smartphone applications for health monitoring is gaining traction, this specific approach to jaundice detection is novel and has not been extensively tested in similar populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gestational age \> 37 weeks * Birth weight \> 2000 g and \< 4500 g * Age \> 24 hours and \< 14 days * Infants requiring a blood sample for clinically suspected jaundice or other screening Exclusion Criteria: * Infants transferred to the pediatric ward for advanced treatment * Infants with a skin rash or other disease that affects the skin where measurements are performed * Infants that receive or have received phototherapy in the last 24 hours * Infants with an inborn disease
Where this trial is running
Gaborone
- Princess Marina Hospital — Gaborone, Botswana (Recruiting)
Study contacts
- Study coordinator: Julie Zimmer, stud.med
- Email: juzim@online.no
- Phone: +4795102393
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.