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Trial record 17 of 2667 for:    bilirubin

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03866213
Recruitment Status : Not yet recruiting
First Posted : March 7, 2019
Last Update Posted : March 7, 2019
University of Malawi College of Medicine
Information provided by (Responsible Party):
William Marsh Rice University

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.

Condition or disease Intervention/treatment Phase
Hyperbilirubinemia, Neonatal Jaundice, Neonatal Diagnostic Test: BiliSpec Not Applicable

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Estimated Study Start Date : March 14, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Arm Intervention/treatment
Experimental: 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
BiliSpec will quantitatively measure the bilirubin content of a neonatal blood sample.

Primary Outcome Measures :
  1. Device Accuracy [ Time Frame: Total duration of hospital stay while inclusion criteria are met (<10 minutes per sample) ]
    Bilirubin content measured by the BiliSpec device compared against the Reichert UNISTAT laboratory spectophotometric bilirubinometer as well as a transcutaneous bilirubinometer.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03866213

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Contact: Paty Figueroa (713) 348-4963
Contact: Jessica Anderson (713) 348-4963

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United States, Texas
Rice University
Houston, Texas, United States, 77030
Queen Elizabeth Central Hospital
Blantyre, Malawi
Kamuzu Central Hospital Not yet recruiting
Lilongwe, Malawi, 30700
Contact: Msandeni Chiume, MD    +265995674740   
Sponsors and Collaborators
William Marsh Rice University
University of Malawi College of Medicine
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Principal Investigator: Rebecca Richards-Kortum, PhD William Marsh Rice University
Principal Investigator: Maria Oden, PhD William Marsh Rice University
Principal Investigator: Queen Dube, MD University of Malawi College of Medicine
Principal Investigator: Msandeni Chiume, MD University of Malawi College of Medicine
  Study Documents (Full-Text)

Documents provided by William Marsh Rice University:
Informed Consent Form  [PDF] October 31, 2018

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Responsible Party: William Marsh Rice University Identifier: NCT03866213     History of Changes
Other Study ID Numbers: BiliSpec-COMREC
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary outcome measures will be made available.
Supporting Materials: Study Protocol
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by William Marsh Rice University:
Low-Resource Setting

Additional relevant MeSH terms:
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Hyperbilirubinemia, Neonatal
Jaundice, Neonatal
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Infant, Newborn, Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs