Evaluation of a Smartphone-based Screening Tool for Neonatal Jaundice in a Ugandan Population

• Sponsor: Picterus AS (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05365399
• Collaborator: Norwegian University of Science and Technology (Other)
• Enrollment: 180
• Location: 1
• Arm: 1
• Actual Duration (Months): 3.4
• Patients Per Site Per Month: 52.7

Study Details

Study Description

Brief Summary

The general objective of this study is to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at HICH Mbarara.

The specific objectives for this study are:

To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin measurements in serum in newborns with varying degree of jaundice 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 To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns with varying degree of jaundice

Condition or Disease	Intervention/Treatment	Phase
Neonatal Jaundice	Device: smartphone-based screening tool for neonatal jaundice	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Evaluation of a Smartphone-based Screening Tool for Neonatal Jaundice in a Ugandan Population
• Actual Study Start Date: May 3, 2022
• Actual Primary Completion Date: Aug 15, 2022
• Actual Study Completion Date: Aug 15, 2022

Arms and Interventions

Arm

Intervention/Treatment

Other: Enable high qualitative estimation of bilirubin levels in the blood of new-borns In this study we aim to collect data of newborns with wider range of bilirubin levels and high melanin content, and additionally measurements of skin color reflectance with a spectrophotometer, to adjust the Picterus JP algorithm and optimize the app performance. This will enable a high qualitative estimation of bilirubin levels in the blood of new-borns for all skin colors. .

Device: smartphone-based screening tool for neonatal jaundice; In this study we aim to collect data of newborns with wider range of bilirubin levels and high melanin content, and additionally measurements of skin color reflectance with a spectrophotometer, to adjust the Picterus JP algorithm and optimize the app performance. This will enable a high qualitative estimation of bilirubin levels in the blood of new-borns for all skin colors. .

Outcome Measures

Primary Outcome Measures

1. Smartphone application sensitivity (bilirubin levels on newborns) [5 minutes]

   Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.

Secondary Outcome Measures

1. Smartphone application sensitivity (bilirubin levels on newborns with high melanin content) in the skin. [5 minutes]

   Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP. Adapt the current algorithm of Picterus JP to newborns with high melanin content in the skin

Eligibility Criteria

Criteria

• Ages Eligible for Study: 24 Hours to 14 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Infants born with gestational age ≥37 weeks

• Birth weight ≥2000g and ≤4500g

• Age 1 - 14 days

• Infants requiring a blood sample (newborn screening / clinically suspected jaundice)

Exclusion Criteria:

• Infants transferred to the paediatric 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mengo Hospital	Kampala		Uganda

Sponsors and Collaborators

• Picterus AS
• Norwegian University of Science and Technology

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Picterus AS
• ClinicalTrials.gov Identifier: NCT05365399
• Other Study ID Numbers: IS 145
• First Posted: May 9, 2022
• Last Update Posted: Aug 23, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Jaundice, Neonatal; Jaundice

Study Results

No Results Posted as of Aug 23, 2022