跳至主要内容
临床试验/NCT06073444
NCT06073444已完成不适用

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

Norwegian University of Science and Technology2 个研究点 分布在 1 个国家目标入组 611 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
611
试验地点
2
主要终点
Difference in the proportion of newborns with a positive total serum bilirubin blood test

研究概览

简要总结

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.

详细描述

Background Neonatal jaundice (NNJ) affects a significant percentage of newborns (60%-80%) within the first 48 to 72 hours of life. Due to increased production and decreased elimination in the newborns, bilirubin accumulates in the blood, causing neonatal hyperbilirubinemia (NHB). While most cases resolve without consequences, severe NHB affects approximately 1.1 million infants annually, necessitating close monitoring and treatment. If undetected, NHB can lead to brain damage and conditions such as acute bilirubin encephalopathy, impaired neurologic development, long-term disabilities (including audiologic, language processing, cognitive and visual-motor disturbances) and, in the worst cases, death.

Currently, reliable detection of NNJ depends on invasive or expensive methods, such as transcutaneous bilirubinometer (TcB) devices and total serum bilirubin (TSB) blood tests, which are limited in most low- and middle-income countries (LMICs) as well as in out-of hospital settings. As a result, detection relies on using visual assessment (VA), an unreliable and inaccurate screening method that leads to a higher prevalence of severe consequences in LMICs than in high-income countries (HICs). This results in preventable health inequities with significant social and economic costs.

In response to these challenges, a Norwegian multidisciplinary research group developed an accessible, affordable mobile health (mHealth) solution called Picterus Jaundice Pro (Picterus JP) to screen for NHB. Picterus JP consists of a smartphone app to capture and upload images of the newborn's skin, a calibration card for accurate colour calibration in the images and a server for image analysis and storage. The app has undergone validation in Norwegian hospitals and in pilot studies in Mexico and the Philippines, demonstrating significant positive correlation between Picterus JP's bilirubin values and TSB levels as well as higher accuracy over VA.

Digital health technologies such as Picterus JP have immense potential to enhance healthcare in resource-constrained areas, but such innovations face implementation challenges that can hinder their adoption, leading to slow, unreliable and unsustainable outcomes, particularly in LMICs, such as Mexico.

To get insights about low-resource settings in Mexico, particularly in the state of Oaxaca, an exploratory study on the field to identify the main barriers and facilitators to implement Picterus JP in urban and rural public health facilities was recetly conducted. Through non-participants observations and interviews deficiencies in the current neonatal jaundice detection process and the participants' desire for a more accurate method were identified. Participants tested Picterus JP on a dummy perceiving the app as easy to use, useful and compatible with the work routine, but barriers to adoption were identified, including internet deficiencies and costs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Investigator)

入排标准

年龄范围
1 Day 至 14 Days(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Difference in the proportion of newborns with a positive total serum bilirubin blood test

时间窗: 6 months

Bilirubin blood level \> 15 mg/dl

次要结局

  • Extent to which Picterus JP aligns with the current care routine(6 months)
  • Extent to which Picterus JP can be used with the current infrastructure(6 months)
  • Extent to which Picterus JP adapts to different conditions(6 months)
  • Extent to which researchers are capable of successfully recruiting participants (Recruitment capability)(6 months)
  • Extent to which health care providers use Picterus JP with fidelity(6 months)
  • Extent to which Picterus increases the detection of newborns needing treatment(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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