Jaundice, Neonatal Clinical Trial
Official title:
Evaluation of a Smartphone Based Screening Tool for Neonatal Jaundice in Surabaya, Indonesia
Verified date | April 2024 |
Source | Picterus AS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A cross-sectional conductive study aiming to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns in Surabaya.
Status | Terminated |
Enrollment | 284 |
Est. completion date | April 29, 2019 |
Est. primary completion date | November 29, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Hour to 14 Days |
Eligibility | Inclusion Criteria: - Infants born with gestational age >31 - Birth weight = 1500g - Age 0 - =14 days - Consent obtained from the parents Exclusion Criteria: - Infants born with congenital abnormalities; - Infants respiratory support; - Infants suffering from a condition that may alter the skin tissue circulatory system, such as sepsis and heart failure; - Infants who have received phototherapy in the last 24 hours. |
Country | Name | City | State |
---|---|---|---|
Indonesia | Airlangga University hospital | Surabaya | East Java |
Indonesia | Dr. Soetomo General Hospital | Surabaya | East Java |
Indonesia | RSIA Kendangsari MERR | Surabaya | East Java |
Lead Sponsor | Collaborator |
---|---|
Picterus AS | RSIA Kendangsaru Surabaya, Universitas Airlangga |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP. | Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in Indonesian newborns. | 5-10 minutes | |
Secondary | Correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborn | To evaluate the correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborns with varying degree of jaundice | 1-2 minutes | |
Secondary | correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns | To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns with varying degree of jaundice | 5-10 minutes | |
Secondary | Correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns | To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns with varying degree of jaundice | 5-10 minutes |
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