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

NCT03866213 | Recruiting

• 1 other identifier: BiliSpec-COMREC
• Study Type: observational
• Target: 1,000
• Locations: 2 countries
• Sites: 3

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.

Conditions

Hyperbilirubinemia, Neonatal; Jaundice, Neonatal

Keywords

Diagnostic; Point-of-Care; Low-Resource Setting

Outcome Measures

Primary Outcomes (1)

• Device Accuracy

  Bilirubin content measured by the BiliSpec device compared against the Reichert UNISTAT laboratory spectophotometric bilirubinometer as well as a transcutaneous bilirubinometer.

  Total duration of hospital stay while inclusion criteria are met (<10 minutes per sample)

Study Arms (1)

Quantitative Measurement of Bilirubin

Bilirubin content of the neonate will be measured by the following: BiliSpec, laboratory spectophotometric bilirubinometer (Reichert UNISTAT), and transcutaneous bilirubinometer. The infant may or may not be receiving phototherapy treatment at the time of sample measurement.

Diagnostic Test: BiliSpec

Interventions

BiliSpec DIAGNOSTIC_TEST

BiliSpec will quantitatively measure the bilirubin content of a neonatal blood sample.

Quantitative Measurement of Bilirubin

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• William Marsh Rice University: lead
• Kamuzu University of Health Sciences: collaborator
• Lagos University Teaching Hospital (LUTH): collaborator

Study Sites (3)

Rice University

Houston, Texas, 77030, United States

ACTIVE NOT RECRUITING

Queen Elizabeth Central Hospital

Blantyre, Malawi

RECRUITING

Kamuzu Central Hospital

Lilongwe, 30700, Malawi

RECRUITING

Related Publications (2)

• 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.

  PMID: 29203650 BACKGROUND

• 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.

  PMID: 35799070 DERIVED

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal; Jaundice, Neonatal; Disease

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rebecca Richards-Kortum, PhD

  William Marsh Rice University

  PRINCIPAL INVESTIGATOR

• Maria Oden, PhD

  William Marsh Rice University

  PRINCIPAL INVESTIGATOR

• Queen Dube, MD

  Kamuzu University of Health Sciences

  PRINCIPAL INVESTIGATOR

• Msandeni Chiume, MD

  Kamuzu University of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Massey, MPH, BSN, RN

CONTACT

713-348-6574; rebecca.elias@rice.edu

Meaghan Bond, PhD

CONTACT

meaghan.mc.bond@rice.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 7, 2019
• Study Start: August 1, 2019
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available within 6 months of study completion.
• Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.

Locations

US (1); MA (2)