Validation of a device for diagnosing jaundice in newborns
Validation of a Low-Cost, Point-of-Care Bilirubin Measurement to Diagnose Neonatal Jaundice and Monitor Phototherapy in Hospitals in Sub-Saharan Africa
This study is testing a new, affordable device called BiliSpec to see if it can accurately check for jaundice in newborns using a small blood sample, especially in places with limited resources.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 0 Days to 28 Days |
| Sex | All |
| Sponsor | William Marsh Rice University Academic / other |
| Locations | 3 sites (Houston, Texas and 2 other locations) |
| Trial ID | NCT03866213 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the BiliSpec device, a low-cost, battery-powered reader that quantifies serum bilirubin levels from a small blood sample. Conducted in partnership with Queen Elizabeth Central Hospital, the study will enroll up to 1000 neonates at risk for jaundice to compare the accuracy of BiliSpec against standard laboratory methods. The goal is to ensure the device functions effectively in low-resource settings, providing a faster and more affordable means of detecting neonatal jaundice and determining the need for phototherapy.
Who should consider this trial
Good fit: Ideal candidates are neonates under 28 days old who are being treated at participating hospitals and are at risk for jaundice or undergoing phototherapy.
Not a fit: Patients whose guardians are unable or unwilling to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly improve the diagnosis and management of neonatal jaundice in low-resource settings.
How similar studies have performed: While similar diagnostic devices have been tested, the BiliSpec device represents a novel approach specifically designed for low-resource settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Houston, Texas and 2 other locations
- Rice University — Houston, Texas, United States (Active_not_recruiting)
- Queen Elizabeth Central Hospital — Blantyre, Malawi (Recruiting)
- Kamuzu Central Hospital — Lilongwe, Malawi (Recruiting)
Study contacts
- Principal investigator: Rebecca Richards-Kortum, PhD — William Marsh Rice University
- Study coordinator: Rebecca Massey, MPH, BSN, RN
- Email: rebecca.elias@rice.edu
- Phone: 713-348-6574
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.