Hyperbilirubinemia, NeonatalNCT03866213
Validation of a Jaundice Diagnostic and Monitoring Device for Low-Resource Settings
An observational study of Hyperbilirubinemia, Neonatal and Jaundice, Neonatal, run by William Marsh Rice University at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Hyperbilirubinemia, Neonatal, Jaundice, Neonatal
- What is being tested?
- BiliSpec
- How many people
- 1,000 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Aug 2019to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries.
Meaghan Bond, PhD contact
3 sites in 2 countries
Malawi2 sites, 2 recruiting
- Recruiting
Queen Elizabeth Central Hospital
Blantyre
Queen Dube, MD, +265999981454, drdubefirst@yahoo.com
Dube
- Recruiting
Kamuzu Central Hospital
Lilongwe, 30700
Msandeni Chiume, MD, +265995674740, msandeni@gmail.com
United States1 site
- Active, not recruiting
Rice University
Houston, Texas, 77030
About this study
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
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.
Read the detailed description
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.
- 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.
- Conditions
- Hyperbilirubinemia, Neonatal, Jaundice, Neonatal
- Being tested
- BiliSpec
- Keywords
- Diagnostic, Point-of-Care, Low-Resource Setting
- Medical subject headings
- Hyperbilirubinemia, Neonatal, Jaundice, Neonatal, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiliSpecDiagnostic test
BiliSpec will quantitatively measure the bilirubin content of a neonatal blood sample.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: BiliSpec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Accuracy
Bilirubin content measured by the BiliSpec device compared against the Reichert UNISTAT laboratory spectophotometric bilirubinometer as well as a transcutaneous bilirubinometer.
Measured: Total duration of hospital stay while inclusion criteria are met (<10 minutes per sample)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start1 Aug 2019
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hyperbilirubinemia, NeonatalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- William Marsh Rice University
- Sponsor type
- University, hospital or other
- Collaborators
- Kamuzu University of Health Sciences, Lagos University Teaching Hospital (LUTH)
- Responsible party
- Sponsor
- Investigators
- Rebecca Richards-Kortum, PhD, Principal investigator, William Marsh Rice UniversityMaria Oden, PhD, Principal investigator, William Marsh Rice UniversityQueen Dube, MD, Principal investigator, Kamuzu University of Health SciencesMsandeni Chiume, MD, Principal investigator, Kamuzu University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866213
- Sponsor's protocol ID
- BiliSpec-COMREC
- Status last verified
- Jun 2024
- First submitted
- 5 Mar 2019
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary outcome measures will be made available.
Publications
Keahey PA, Simeral ML, Schroder KJ, Bond MM, Mtenthaonnga PJ, Miros RH, Dube Q, Richards-Kortum RR. Point-of-care device to diagnose and monitor neonatal jaundice in low-resource settings. Proc Natl Acad Sci U S A. 2017 Dec 19;114(51):E10965-E10971. doi: 10.1073/pnas.1714020114. Epub 2017 Dec 4.
PubMed 29203650Shapiro A, Anderson J, Mtenthaonga P, Kumwenda W, Bond M, Schwarz R, Carns J, Johnston R, Dube Q, Chiume M, Richards-Kortum R. Evaluation of a Point-of-Care Test for Bilirubin in Malawi. Pediatrics. 2022 Aug 1;150(2):e2021053928. doi: 10.1542/peds.2021-053928.
PubMed 35799070
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03866213
- Acronym / sponsor ID
- BiliSpec-COMREC
- Conditions
- Hyperbilirubinemia, Neonatal, Jaundice, Neonatal
- Keywords
- Diagnostic, Point-of-Care, Low-Resource Setting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- William Marsh Rice UniversityUniversity, hospital or other
- Collaborators
- Kamuzu University of Health Sciences, Lagos University Teaching Hospital (LUTH)
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quantitative Measurement of Bilirubin | – | Diagnostic Test: BiliSpecBilirubin 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. |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiliSpecBiliSpec will quantitatively measure the bilirubin content of a neonatal blood sample. | Diagnostic test | Quantitative Measurement of Bilirubin |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Background: PubMed 29203650Keahey PA, Simeral ML, Schroder KJ, Bond MM, Mtenthaonnga PJ, Miros RH, Dube Q, Richards-Kortum RR. Point-of-care device to diagnose and monitor neonatal jaundice in low-resource settings. Proc Natl Acad Sci U S A. 2017 Dec 19;114(51):E10965-E10971. doi: 10.1073/pnas.1714020114. Epub 2017 Dec 4.
- Derived from this study: PubMed 35799070Shapiro A, Anderson J, Mtenthaonga P, Kumwenda W, Bond M, Schwarz R, Carns J, Johnston R, Dube Q, Chiume M, Richards-Kortum R. Evaluation of a Point-of-Care Test for Bilirubin in Malawi. Pediatrics. 2022 Aug 1;150(2):e2021053928. doi: 10.1542/peds.2021-053928.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meaghan Bond, PhD contact
Rebecca Richards-Kortum, PhD principal investigator
William Marsh Rice University
Maria Oden, PhD principal investigator
William Marsh Rice University
Queen Dube, MD principal investigator
Kamuzu University of Health Sciences
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperbilirubinemia, Neonatal and Jaundice, Neonatal, run by William Marsh Rice University at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Malawi, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Massey, MPH, BSN, RN (713-348-6574, rebecca.elias@rice.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Accuracy (time frame: Total duration of hospital stay while inclusion criteria are met (<10 minutes per sample)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03866213, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.