Evaluation of Bilirubin Measurements in Newborns From Smartphone Digital Images in a Population in Botswana
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Picterus AS
- Enrollment
- 172
- Locations
- 1
- Primary Endpoint
- Enable high qualitative estimation of bilirubin levels in the blood of newborns in a population in Botswana using Picterus JP.
Study Overview
Brief Summary
The general objective of this study is to evaluate the accuracy of a novel smartphone application for jaundice screening (Picterus Jaundice Pro) in a population with high melanin content in the skin.
The specific objectives for this study are:
i. To assess the correlation between bilirubin level measurements obtained by Picterus Jaundice Pro with Total Serum Bilirubin (TSB), and TcB, in newborns with high melanin content in the skin.
ii. To determine the accuracy of Picterus Jaundice Pro in newborns with high melanin content in the skin.
Detailed Description
The goal for this project is to demonstrate that the Picterus Jaundice Pro screening method can be used to identify children with severe neonatal jaundice independent of skin color. Thus, providing a cheaper, patient-friendly, and more readily available method of neonatal jaundice detection. The long-term goal is that with the implementation of the app, the identification of newborns with severe jaundice will be improved and, thus, referred at an earlier stage for diagnostics and treatment.
The study will be a cross-sectional study with quantitative methods of data collection.
The study population will comprise 150 newborns from the Neonatal Unit and the maternity ward at Princess Marina Hospital.
Parents to newborns with and without signs of jaundice will be asked to participate.
Following informed consent, background data such as birth weight, age on examination, gestational age, and type of feeding will be obtained. Gestational age will be based on ultrasound determination and the last normal menstruation period (LNMP). The skin type of the infant will be classified according to the newborn Neomar's scale score.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 1 Day to 14 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Gestational age > 37 weeks
- •Birth weight > 2000 g and < 4500 g
- •Age 1-14 days
- •Infants requiring a blood sample for clinically suspected jaundice/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.
Outcomes
Primary Outcomes
Enable high qualitative estimation of bilirubin levels in the blood of newborns in a population in Botswana using Picterus JP.
Time Frame: 1 year
Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns with high melanin content.
Secondary Outcomes
- Correlation of bilirubin levels obtained by Picterus JP with Tsb and TcB(1-2 hours)
- Sensitivity and specificity of Picterus JP to detect jaundice in newborns with high melanin content in the skin(1 year)