Validation of a Jaundice Diagnostic and Monitoring Device for Low-Resource Settings

This study will validate the accuracy of the BiliSpec device in measuring bilirubin levels in
neonates relative to a laboratory spectrophotometric bilirubinometer (Reichert UNISTAT®
Bilirubinometer) and transcutaneous bilirubinometer measurements.

This study will enroll up to 500 neonates at Queen Elizabeth Central Hospital and Kamuzu
Central Hospital each, for a total of up to 1000 neonates, at risk for jaundice based on
clinical signs and symptoms or undergoing phototherapy for treatment of jaundice. During the
pilot study, 100 participants were evaluated and 147 samples total were collected. However
only 7 samples collected were over 20 mg/dL. In addition to confirming the accuracy of
BiliSpec in this validation study, enough samples of clinically high bilirubin concentrations
(>20mg/dL) will need to be collected to ensure the device functions properly over the
intended dynamic range (0-35 mg/dL). To accomplish this, data from up to 500 participants at
each location will be collected.

Informed consent will be requested from the parents of all eligible babies on the ward for
this study. If the guardian does not consent, the patient's bilirubin levels will be assessed
using the standard of care on the ward.

During the trial, the following steps will be taken:

The trained study nurse will assess the subject for clinical complications before performing
the necessary heel prick blood draw.

- A transcutaneous measurement of bilirubin and a heel stick will be performed on the
neonate by a trained study nurse or clinician.

- One drop of blood will be collected on the sample card and immediately used for
analysis. BiliSpec will be operated by a trained nurse or trained research assistant.

- Another drop of blood, collected in a capillary tube, will be centrifuged and then
measured using the laboratory spectrophotometric bilirubinometer (Reichert UNISTAT®
Bilirubinometer 1310310C). The spectrophotometric bilirubinometer will be operated by
trained research assistants from the Rice department of bioengineering and the
University of Malawi. Bilirubin concentration values measured by the gold standard
laboratory bilirubinometer will be used to guide diagnosis.

Measurements will be made at multiple time points as indicated clinically.

The neonatal bilirubin concentration in mg/dL will be determined using the BiliSpec device,
the gold standard laboratory spectrophotometric bilirubinometer, and the transcutaneous
bilirubinometer described in the testing procedure. Measurements of bilirubin levels will be
compared. All data will be recorded using a pre-determined data collection form. Analysis of
the usability and robustness of BiliSpec will also be performed with regards to usability and
device function by maintaining a log of any user error in using the device and a log of any
observed device malfunctions. Data will also be collected on the effectiveness of BiliSpec to
monitor neonates undergoing phototherapy.

Personal identifiers will be removed and confidentiality of the subjects will be strictly
preserved. The data will be kept on a secure server accessible only to the study personnel.

Inclusion Criteria:

- The patient is currently being treated at Queen Elizabeth Central Hospital or Kamuzu
Central Hospital in the neonatal ward.

- The patient is less than 28 days old (neonate).

- The patient is deemed to be at risk for jaundice or the patient is undergoing blue
light phototherapy for treatment of jaundice.

- The patient's parent or guardian has provided informed consent for their child to
participate.

Exclusion Criteria:

- Parent or guardian is unable or unwilling to provide informed consent.

- The patient is unable to receive a blood draw/heel stick as determined by their
clinician.