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mHealth to Screen for Neonatal Jaundice in Low-resource Mexican Settings: a Feasibility Study

NCT06073444 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 611

Last updated 2024-08-12

No results posted yet for this study

Summary

Neonatal jaundice (NNJ) is a common condition in newborns during the first week of life due to increased levels of bilirubin. Usually, it resolves without consequences after 7 to 10 days. However, around 10% of the newborns develop a severe form, which if is not detected on time, can lead to irreversible consequences including brain damage, disabilities and even death.

The goal of this study is to determine the feasibility of implementing a smartphone app (Picterus JP) to screen for NNJ in low resource health facilities in Mexico and to evaluate its potential effectiveness to detect severe cases of the condition compared to the current used method that consists in visual assessment (VA).

Research questions are:

1. Is it feasible to implement the smartphone app Picterus JP to screen for NNJ in low resource health facilities in Mexico?
2. Will Picterus JP increase the detection of severe NNJ compared to VA?

Participants will include:

1. Newborns who attend the health facilities for neonatal check up
2. Health care workers (HCWs) using the app
3. Parents of newborns screened with Picterus JP

Methodology:

Mothers will be asked to consent their newborn's participation. The newborns will be then randomly assigned to either:

1. control group in which jaundice will be screened by healthcare workers using VA or
2. intervention group in which jaundice will be screened using Picterus JP in addition to VA

If the bilirubin measurement with Picterus is \>15 mg/dl or there is suspicion of severe NNJ by VA, newborns will be referred to emergency room for further evaluation by a doctor and/or measure the level of bilirubin in blood.

Researchers will compare the number of bilirubin blood levels \>15 mg/dl between the two groups.

HCWs and newborns' parents will be interviewed to identify their perceptions and experiences towards the use of the app.

Conditions

  • Neonatal Jaundice

Interventions

DEVICE

Picterus JP

Picterus JP is a medical device consisting in a smartphone app which is use to take images of the skin of the newborn, a color calibration card that must be placed in the newborn chest to calibrate color and lighting in the images and a server to analyze data and estimate bilirubin level

Sponsors & Collaborators

  • Picterus AS

    collaborator INDUSTRY

  • Instituto Mexicano del Seguro Social

    collaborator OTHER_GOV

  • Norwegian University of Science and Technology

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06073444 on ClinicalTrials.gov