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Evaluation of a Smartphone Based Diagnostic Tool to Assess Neonatal Jaundice in a Mexican Population

Primary Purpose

Jaundice, Neonatal

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Picterus Jaundice Pro
Sponsored by
Picterus AS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Jaundice, Neonatal

Eligibility Criteria

0 Days - 14 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy newborns with or without signs of jaundice Gestational age >35 weeks Age 0-14 days Birth weight > 1500 g. Parents acceptance of their children to participate in the study. Newborn needing a blood test Exclusion Criteria: Newborns showing signs or with diagnosis of inborn diseases Newborn transferred to pediatric ward for any treatment Newborns who had received phototherapy.

Sites / Locations

  • Hospital Materno- Infantil de Irapuato

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Enable high qualitative estimation of bilirubin levels in the blood of new-borns

Arm Description

There is only one arm in this study which is to enable high qualitative estimation of bilirubin levels in the blood of new-borns, independent of skin color, using Picterus JP.

Outcomes

Primary Outcome Measures

Enable high qualitative estimation of bilirubin levels in the blood of newborns using Picterus JP
Evaluate of smartphone-based diagnostic tool (Picterus JP) for neonatal jaundice in newborns.

Secondary Outcome Measures

Correlation with TsB
Demonstrate the correlation among the estimated levels of bilirubin obtained through a smartphone based diagnostic tool with bilirubin serum levels in a population of Mexican neonates.
Correlation with TcB
Demonstrate the correlation among the estimated levels of bilirubin obtained through a smartphone based diagnostic tool with those obtained using a transcutaneous bilirubinometer in a population of Mexican neonates.
Correlation with visual assessment
Demonstrate the correlation among the estimated levels of bilirubin obtained through a smartphone based diagnostic tool with those obtained using visual Kramer scale in a population of Mexican neonates.

Full Information

First Posted
November 8, 2022
Last Updated
November 18, 2022
Sponsor
Picterus AS
Collaborators
Norwegian University of Science and Technology Faculty of Medicine and Health Sciences Department of Public Health and Nursing, Hospital Materno- Infantil de Irapuato
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1. Study Identification

Unique Protocol Identification Number
NCT05623553
Brief Title
Evaluation of a Smartphone Based Diagnostic Tool to Assess Neonatal Jaundice in a Mexican Population
Official Title
Evaluation of a Smartphone Based Diagnostic Tool to Assess Neonatal Jaundice in a Mexican Population
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
July 11, 2018 (Actual)
Study Completion Date
August 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Picterus AS
Collaborators
Norwegian University of Science and Technology Faculty of Medicine and Health Sciences Department of Public Health and Nursing, Hospital Materno- Infantil de Irapuato

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This corss-sectional study aims to test the performance and accuracy of the Picterus JP screening device in newborns with different skin types.
Detailed Description
A descriptive cross-sectional study among 174 newborns was carried out at Hospital Materno-Infantil de Irapuato in Mexico during July and August 2018. The Picterus Calibration Card will be placed on the chest of the newborn with the hole in the card placed over the infant's sternum. A validated smartphone with Picterus JP will be used to collect digital images..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaundice, Neonatal

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enable high qualitative estimation of bilirubin levels in the blood of new-borns
Arm Type
Experimental
Arm Description
There is only one arm in this study which is to enable high qualitative estimation of bilirubin levels in the blood of new-borns, independent of skin color, using Picterus JP.
Intervention Type
Device
Intervention Name(s)
Picterus Jaundice Pro
Other Intervention Name(s)
Picterus JP
Intervention Description
Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place.
Primary Outcome Measure Information:
Title
Enable high qualitative estimation of bilirubin levels in the blood of newborns using Picterus JP
Description
Evaluate of smartphone-based diagnostic tool (Picterus JP) for neonatal jaundice in newborns.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Correlation with TsB
Description
Demonstrate the correlation among the estimated levels of bilirubin obtained through a smartphone based diagnostic tool with bilirubin serum levels in a population of Mexican neonates.
Time Frame
1-2 hours
Title
Correlation with TcB
Description
Demonstrate the correlation among the estimated levels of bilirubin obtained through a smartphone based diagnostic tool with those obtained using a transcutaneous bilirubinometer in a population of Mexican neonates.
Time Frame
5-10 minutes
Title
Correlation with visual assessment
Description
Demonstrate the correlation among the estimated levels of bilirubin obtained through a smartphone based diagnostic tool with those obtained using visual Kramer scale in a population of Mexican neonates.
Time Frame
5-10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy newborns with or without signs of jaundice Gestational age >35 weeks Age 0-14 days Birth weight > 1500 g. Parents acceptance of their children to participate in the study. Newborn needing a blood test Exclusion Criteria: Newborns showing signs or with diagnosis of inborn diseases Newborn transferred to pediatric ward for any treatment Newborns who had received phototherapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth Darj, Prof, MD, PhD
Organizational Affiliation
NTNU Faculty of Medicine and Health Sciences, Department of Public Health and Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Materno- Infantil de Irapuato
City
Irapuato
State/Province
Guanajuato
ZIP/Postal Code
36546
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&cad=rja&uact=8&ved=2ahUKEwjw9pvJvpz7AhWGaMAKHVWXB3EQFnoECF0QAQ&url=https%3A%2F%2Fntnuopen.ntnu.no%2Fntnu-xmlui%2Fbitstream%2Fhandle%2F11250%2F2616837%2Fno.ntnu%253Ainspera%253A2379649.pdf%3Fsequence%3D1&usg=AOvVaw10PdE6VGVgBoTdKsQ-0AUs
Description
Master thesis describing the study and its results

Learn more about this trial

Evaluation of a Smartphone Based Diagnostic Tool to Assess Neonatal Jaundice in a Mexican Population

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