Clinical trial NCT03866213: Validation of a Jaundice Diagnostic and Monitoring Device for Low-Resource Settings
Official title: Validation of a Low-Cost, Point-of-Care Bilirubin Measurement to Diagnose Neonatal Jaundice and Monitor Phototherapy in Hospitals in Sub-Saharan Africa
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hyperbilirubinemia, Neonatal
Jaundice, Neonatal
Keywords: Diagnostic
Point-of-Care
Low-Resource Setting
Lead sponsor: William Marsh Rice University
Sponsor class: OTHER
Collaborators: name: Kamuzu University of Health Sciences
name: Lagos University Teaching Hospital (LUTH)
First posted: 2019-03-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients currently being treated at Queen Elizabeth Central Hospital or Kamuzu Central Hospital in the neonatal ward, who are less than 28 days old (neonate), and deemed to be at risk for jaundice or the patient is undergoing blue light phototherapy for treatment of jaundice.

Brief summary: A team of researchers at Rice University in partnership with clinicians at Queen Elizabeth Central Hospital created BiliSpec, a low-cost battery-powered reader designed to immediately quantify serum bilirubin levels from a small drop of whole blood applied to a lateral flow strip. The simple and affordable BiliSpec system offers a faster and more cost-effective means to detect neonatal jaundice in under-resourced clinics and determine when phototherapy is needed. The goal of this study is to validate the accuracy of the BiliSpec device in measuring bilirubin levels in neonates relative to the laboratory spectrophotometric bilirubinometer and transcutaneous bilirubinometer measurements.

Detailed description: 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 study, 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Device Accuracy
timeFrame: Total duration of hospital stay while inclusion criteria are met (<10 minutes per sample)
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Rice University
state: Texas
city: Blantyre
country: Malawi
facility: Queen Elizabeth Central Hospital
city: Lilongwe
country: Malawi
facility: Kamuzu Central Hospital
Study officials:
affiliation: William Marsh Rice University
name: Rebecca Richards-Kortum, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: William Marsh Rice University
name: Maria Oden, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kamuzu University of Health Sciences
name: Queen Dube, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kamuzu University of Health Sciences
name: Msandeni Chiume, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Keahey PA, Simeral ML, Schroder KJ, Bond MM, Mtenthaonnga PJ, Miros RH, Dube Q, Richards-Kortum RR. Point-of-care device to diagnose and monitor neonatal jaundice in low-resource settings. Proc Natl Acad Sci U S A. 2017 Dec 19;114(51):E10965-E10971. doi: 10.1073/pnas.1714020114. Epub 2017 Dec 4.
citation: Shapiro A, Anderson J, Mtenthaonga P, Kumwenda W, Bond M, Schwarz R, Carns J, Johnston R, Dube Q, Chiume M, Richards-Kortum R. Evaluation of a Point-of-Care Test for Bilirubin in Malawi. Pediatrics. 2022 Aug 1;150(2):e2021053928. doi: 10.1542/peds.2021-053928.