Validation of a Jaundice Diagnostic and Monitoring Device for Low-Resource Settings
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|ClinicalTrials.gov Identifier: NCT03866213|
Recruitment Status : Not yet recruiting
First Posted : March 7, 2019
Last Update Posted : March 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hyperbilirubinemia, Neonatal Jaundice, Neonatal||Diagnostic Test: BiliSpec||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03866213
|Contact: Paty Figueroa||(713) firstname.lastname@example.org|
|Contact: Jessica Anderson||(713) email@example.com|
|United States, Texas|
|Houston, Texas, United States, 77030|
|Queen Elizabeth Central Hospital|
|Kamuzu Central Hospital||Not yet recruiting|
|Lilongwe, Malawi, 30700|
|Contact: Msandeni Chiume, MD +265995674740 firstname.lastname@example.org|
|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|