Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06073444 |
| Other study ID # |
519379 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2024 |
| Est. completion date |
June 30, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Norwegian University of Science and Technology |
| Contact |
Jimenez Diaz |
| Phone |
+4745914516 |
| Email |
gabriela.j.diaz[@]ntnu.no |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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.
The aim of this study is to evaluate the feasibility of introducing Picterus JP as a tool to
screen for neonatal jaundice in low-income settings of Mexico by examining whether and how
the app can be implemented and evaluated.
Feasibility studies are usually conducted prior to outcome-focused pilot studies or
full-scale evaluation of an intervention effectiveness and are more focused in the
intervention process than in the intervention outcomes. Aspects to evaluate in feasibility
studies include: recruitment capability; appropriateness of data collection procedures and
outcome measures; acceptability of the intervention and study procedures; adaptability,
practicality and integration of the intervention; effectiveness of the intervention; and
participant responses to the intervention.
Specific Objectives:
1. Assess the recruitment capability.
2. Assess the adaptability, practicality, and integration of Picterus JP
3. Assess the acceptability of Picterus JP among health care workers and newborn parents.
4. Describe the potential effectiveness of Picterus JP compared to the standard care.
Methodology:
Study design: feasibility RCT Study setting: Rural Hospital Bienestar No 36 in Tlacolula
(HR36), Oaxaca, Mexico.
Participants:
- Health care workers providing neonatal care at the "preventive medicine unit" and
emergency room in the Rural Hospital Bienestar No. 36, Tlacolula, Oaxaca, Mexico.
- Newborns attending the preventive medicine unit for metabolic screening and
immunization.
- Parents of newborns screened with Picterus JP for neonatal jaundice
Sample size or rationale for determining a feasible sample size: no formal sample size
calculation is needed for feasibility studies. We aim to recruit 6-8 health care workers,
10-12 newborn parents, and at least 200 newborns in each arm for the intervention study based
on the sample size requiered for an RCT with 90 percent power and alfa = 0.05.
Procedures:
1. The HCWs will be informed about the study and will receive training on the use of
Picterus JP by the researcher prior to the start of the study.
2. The baseline values of the study parameters will be determined by measuring them for 1
month prior to the start of the intervention.
3. Newborn participants will be identified by the research assistant in the hospital
waiting room when they come to the neonatal metabolic screening or immunization.
4. Prior extensive information about the study, informed consent will be requested from the
parents and/or guardians of the newborns.
5. Once the informed consent letter has been signed by the parents or guardians (the
signature of only one of them will suffice, that is, the mother or father or guardian)
and two witnesses, the participants will be randomly assigned to either of the two study
groups (intervention or control) before proceeding to the consultation room.
6. In the intervention group, the HCW will use Picterus JP in addition to SC to screen for
NNJ. To do the screening with Picterus, a paper calibration card will be placed on the
newborn's chest and six images will be captured with a validated phone with the app
downloaded, which will be analysed by the software to later show the bilirubin level
measured.
7. In the control group, the HCW will use only the SC to screen for NNJ.
8. In case that Picterus JP shows a bilirubin value of 12 mg/dl or higher or the HCW
suspects of severe jaundice through SC, the newborn will be referred to emergency room
for further evaluation by a medical doctor.
9. The data collection will be carried out for 6 months.
10. HCWs who used the app will be interviewed by the main researcher at the end of the data
collection to explore their experiences and perceptions towards the use and acceptance
of Picterus JP.
11. A questionnaire to explore attitudes towards the use of Picterus in their child will be
applied to parents of newborns.
Data analysis:
The results will be analysed by descriptive statistics for outcomes 1,2 and 3c; by thematic
analysis for outcomes 3a, 3b and 4; and by X2 tests to compare proportions of variables for
outcome 5 (independent variable = introduction of Picterus as a tool to detect NNJ; dependent
variables = number of newborns referred to laboratory for blood test, number of referred
newborns with positive blood tests, number of newborns hospitalized with NNJ as main
diagnosis and number of newborns receiving NNJ specific treatment).
