An observational study in Hyperbilirubinemia, Neonatal and Jaundice, Neonatal, sponsored by William Marsh Rice University. Recruiting at 3 sites in 2 countries. Open to participants aged 0 Days to 28 Days. Per ClinicalTrials.gov, last updated 2024-06-07.
Sponsored by William Marsh Rice University · Observational
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.
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 study, 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.
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.
110 studies on the registry are indexed under Jaundice, Neonatal; 28 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 405 across 27 observational studies indexed under Jaundice, Neonatal.
Browse Jaundice, Neonatal studies →William Marsh Rice University is the lead sponsor of 17 studies on the registry; 7 are open to participants now.
Compared within Jaundice, Neonatal, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hyperbilirubinemia, Neonatal. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients currently being treated at Queen Elizabeth Central Hospital or Kamuzu Central Hospital in the neonatal ward, who are less than 28 days old (neonate), and deemed to be at risk for jaundice or the patient is undergoing blue light phototherapy for treatment of jaundice.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Bilirubin content measured by the BiliSpec device compared against the Reichert UNISTAT laboratory spectophotometric bilirubinometer as well as a transcutaneous bilirubinometer.
Time frame: Total duration of hospital stay while inclusion criteria are met (<10 minutes per sample)
Not enrolling at this site.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified individual participant data for all primary outcome measures will be made available.
Supporting information: Study protocol, Informed consent form
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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