Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06399146 |
| Other study ID # |
JZimmer |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2023 |
| Est. completion date |
October 1, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Hillerod Hospital, Denmark |
| Contact |
Julie Zimmer, stud.med |
| Phone |
+4795102393 |
| Email |
juzim[@]online.no |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This project aims to test a novel smartphone application, Picterus, which provides a cheaper,
patient-friendly, and more readily means of neonatal jaundice detection. For this purpose,
the study aims to collect data from newborns with a broad range of bilirubin levels and high
melanin content in a population in Botswana.
Description:
Neonatal jaundice is a condition in newborns with elevated levels of the waste product
bilirubin, also known as hyperbilirubinemia. It is primarily caused by a combination of the
rapid turnover of red blood cells and the immature liver functions in the newborn. Neonatal
jaundice affects approximately 60 to 80 % of newborns but is usually self-limiting and
harmless. The condition is still potentially dangerous because bilirubin can accumulate in
the basal ganglia of the brain, where it can cause permanent brain damage. Such brain damage,
better known as kernicterus, can manifest as cerebral palsy, deafness, language difficulty,
or in the worst cases, be fatal.
This study will be conducted at a hospital in Botswana, where the study aim to collect data
from newborns with a broad range of bilirubin levels and high melanin content.
The investigators hypothesize that the Picterus JP will offer bilirubin level estimates that
are highly correlated to bilirubin levels measured in blood samples in a population in
Botswana. Following our hypothesis, the short-term goal for this project is to demonstrate
that this screening method can be used to identify children with severe neonatal jaundice
independent of skin color. Thus, providing a cheaper, patient-friendly, and more readily
available means of neonatal jaundice detection.
The study will be a diagnostic accuracy cross-sectional study with quantitative methods of
data collection.
The study population will comprise 150 newborns from the Neonatal Unit and the postnatal ward
at Princess Marina Hospital, a number determined by a sample size calculation based on
standard errors of the 95% limit agreement, as described by Bland and Alman.
The study objective of this study is two-folded. First, to determine the correlation between
TSB measurement and Picterus image estimate of serum-bilirubin. Second, to determine the
accuracy of the Picterus App used as a screening tool.
Following informed consent, background data such as birth weight, age on examination,
gestational age, and type of feeding will be obtained. The skin type of the infant will be
classified according to the newborn Neomar's scale score.
Transcutaneous bilirubin estimates will be performed over the sternum of the infant. A Dräger
Jaundice Meter JM-105 will be used in this study.
Skin reflectance will be done using a CE-marked portable Konica Minolta spectrophotometer
CM-700d. The spectrophotometer readings will be used to adjust the existing algorithm from
Picterus to African skin and thereafter bilirubin estimates from the taken images will be
determined.
The Picterus calibration card will be fixed in place with a disposable back sticker on the
newborn's chest with the hole of the card placed over the infant's sternum. A validated
smartphone with Picterus JP will then be used to collect digital images, as shown below. Once
the phone is aligned with the card, two sets of 6 images of each newborn will be captured, 3
with flash and 3 without flash. After all the images are obtained, a unique ID will be
displayed on the smartphone. This ID will be recorded on the case report forms and later used
to pair clinical data and digital images.
A blood sample to determine TSB will be obtained within 60 minutes of obtaining the images
and processed at the Department of clinical biochemistry in the hospital laboratory. In
addition, TSB will be measured with neonatal bilirubin analyzer Neo-Bil Plus from DAS to
assess the quality of the equipment. For the hospital laboratory analysis, 1 ml of blood is
required and will be obtained either by venous puncture or heel prick. An additional 10 μl
volume of blood will be collected in a heparinized capillary tube for analysis in the Neo-Bil
Plus equipment.
The bilirubin estimates from the images taken will be determined. The images will be compared
to the TSB, NeoBil and TcB measurements using the Pearson correlation coefficient.
Sub-analysis for the different skin colors, gestational ages, days of life, and bilirubin
levels will be performed for the TSB and image estimate. Sensitivity and specificity analysis
will be calculated for different cut-off values using the ROC analysis. Systematic over- or
under-estimation of bilirubin levels will be evaluated using Bland-Altman plots. To avoid
bias, the developer of the product - Picterus AS - will not be involved in statistical
work-up or even see the raw data.
The results from this study will have relevance for the potential validation of the
innovation. Studies demonstrating the tool's potential in a high-burden setting will be
necessary for users of the device. This is the first validation study following the study in
Uganda. The results of this study will result in a published paper in a peer-reviewed
journal. Further, the study's results will be communicated through popular media and seminars
in both countries.
