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NCT05623553 Clinical Trial

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

Jaundice, Neonatal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05623553
Other study ID # 2018/1001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2018
Est. completion date August 8, 2018

Study information
Verified date November 2022
Source Picterus AS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This corss-sectional study aims to test the performance and accuracy of the Picterus JP screening device in newborns with different skin types.

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..

Recruitment information / eligibility
Status Completed
Enrollment 174
Est. completion date August 8, 2018
Est. primary completion date July 11, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 0 Days to 14 Days
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Picterus Jaundice Pro
Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place.

Locations
Country Name City State
Mexico Hospital Materno- Infantil de Irapuato Irapuato Guanajuato

Sponsors (3)
Lead Sponsor Collaborator
Picterus AS Hospital Materno- Infantil de Irapuato, Norwegian University of Science and Technology Faculty of Medicine and Health Sciences Department of Public Health and Nursing

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 6 months
Secondary 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. 1-2 hours
Secondary 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. 5-10 minutes
Secondary 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. 5-10 minutes
See also
  Status Clinical Trial Phase
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Completed NCT00114543 - Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight Phase 3
Withdrawn NCT04021927 - Development of a Neonatal Jaundice Treatment Accelerator by Redirection of Unused Light During Phototherapy N/A
Completed NCT01887327 - Stannsoporfin With Light Therapy for Newborn Babies With Jaundice Phase 2
Completed NCT04632888 - The Effect of Telephone Support for Breastfeeding Follow-up on Infantile Colic and Maternal Breastfeeding Self-efficacy N/A
Not yet recruiting NCT04527536 - Research of Diagnostic Value for BMJ Infants
Suspended NCT03741803 - Relationship Between Delayed Cord Clamping at Birth and Neonatal Bilirubin Levels in Parturients With a Prior Child Requiring Therapy for Neonatal Jaundice N/A
Completed NCT05650463 - Evaluation of a Smartphone-based Screening Tool (Picterus Jaundice Pro) for Neonatal Jaundice in Dark Skin Newborns N/A
Terminated NCT05623566 - Evaluation of a Smartphone Based Screening Tool for Neonatal Jaundice in Surabaya, Indonesia N/A
Completed NCT02612727 - Filtered Sunlight Phototherapy to Treat Significant Jaundice: Safety and Efficacy in Neonates N/A
Completed NCT01434810 - Treatment of Neonatal Jaundice With Filtered Sunlight Phototherapy: Safety and Efficacy in African Neonates N/A
Completed NCT03184948 - Understanding Neonatal Jaundice in Rwanda N/A
Completed NCT03942757 - BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator
Not yet recruiting NCT05806684 - Hyperbilirubinemia and Retinopathy of Prematurity in Preterm Infants: a Retrospective Study.
Completed NCT06372093 - Evaluation of Bilirubin Measurements in Newborns From Smartphone Digital Images in a Population in Botswana N/A
Completed NCT03570775 - Effectiveness, Safety and Perceptions With the Use of One LED Sleeping Bag Device in the Treatment of Neonatal Jaundice N/A
Completed NCT03569254 - Effectiveness, Safety and Perceptions With the Use of One LED Blanket Device in the Ambulatory Treatment of Jaundice N/A
Completed NCT05625880 - Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Nepali Population N/A
Completed NCT01169740 - Transcutaneous Measurement of Jaundice in the Newborn N/A
Not yet recruiting NCT06449508 - The Effectiveness of Probiotics in Neonatal Jaundice Phase 1/Phase 2

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