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NCT03866213 · ClinicalTrials.gov registry record
Validation of a Jaundice Diagnostic and Monitoring Device for Low-Resource Settings
A clinical trial of Hyperbilirubinemia, Neonatal and Jaundice, Neonatal, sponsored by William Marsh Rice University.
- Recruiting
- Registry status
- 1,000
- Enrollment target
- 3
- Study locations
NCT03866213 is a study of Hyperbilirubinemia, Neonatal and Jaundice, Neonatal that is actively recruiting participants, run by William Marsh Rice University. The registered enrollment target is 1,000 participants. The trial reports 3 study locations across 2 states.
The verdict
NCT03866213, a study of Hyperbilirubinemia, Neonatal and Jaundice, Neonatal, is actively recruiting participants, sponsored by William Marsh Rice University.
- RECRUITING
- Registry status
- 1,000 participants
- Enrollment target
- 3
- Study locations
Study 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 Studied
Interventions
- DIAGNOSTIC_TEST BiliSpec
Study Locations (3)
Other
- Queen Elizabeth Central Hospital - Blantyre
- Kamuzu Central Hospital - Lilongwe
Texas
- Rice University - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2019-08-01 |
| Est. Completion | 2024-08-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03866213
The ClinicalTrials.gov registry entry for NCT03866213 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is William Marsh Rice University, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Hyperbilirubinemia, Neonatal appearing as the primary indexed condition, and to 1 intervention - of which BiliSpec is the first listed.
NCT03866213 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Other, Texas.
Frequently Asked Questions
What is clinical trial NCT03866213 about?
NCT03866213 is a clinical study titled "Validation of a Jaundice Diagnostic and Monitoring Device for Low-Resource Settings". 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 aff...
What is the current status of trial NCT03866213?
This trial is currently recruiting. The enrollment target is 1,000 participants. The study started on 2019-08-01. Estimated completion is 2024-08-31.
What conditions does trial NCT03866213 study?
This clinical trial studies the following conditions: Hyperbilirubinemia, Neonatal, Jaundice, Neonatal.
What interventions are being tested in trial NCT03866213?
The interventions under investigation include: BiliSpec (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03866213?
This trial is sponsored by William Marsh Rice University, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03866213 being conducted?
This trial has 3 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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