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NCT03866213
Validation of a Jaundice Diagnostic and Monitoring Device for Low-Resource Settings
trial testing BiliSpec in Hyperbilirubinemia, Neonatal in 1,000 participants. Currently enrolling.
31 August 2024
Quick facts
| Lead sponsor | William Marsh Rice University |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 1,000 |
| Start date | 1 August 2019 |
| Primary completion | 31 August 2024 |
| Estimated completion | 31 August 2024 |
| Sites | 3 locations across Malawi, United States |
Drugs / interventions tested
- BiliSpec
Conditions studied
- Hyperbilirubinemia, Neonatal — all drugs for Hyperbilirubinemia, Neonatal →
- Jaundice, Neonatal — all drugs for Jaundice, Neonatal →
Sponsor
William Marsh Rice University
Who can join
Adults 0 Days to 28 Days, any sex, with Hyperbilirubinemia, Neonatal or Jaundice, Neonatal. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03866213
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03866213 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by William Marsh Rice University
- Last refreshed: 7 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03866213.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing