Jaundice, NeonatalNCT06687746
Evaluation of Bili-ruler, a Low-cost, Plastic Icterometer for Community-based Screening of Jaundice in Newborns
An observational study of Jaundice, Neonatal and Neonatal Diseases and Abnormalities, run by George Washington University at 5 sites in 4 countries.
Trial summary
Newborn jaundice, or accumulation of bilirubin molecules in blood, affects 60-80% of newborns and, in severe cases, places newborns at risk of brain damage and death. Universal screening of all newborn for jaundice ensures that at-risk newborns are identified and treated early. Read more about this study
- Who is it for?
- Ages Up to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Jaundice, Neonatal, Neonatal Diseases and Abnormalities, Neonatal Hyperbilirubinemia
- What is being tested?
- Bili-ruler
- Type of treatment
- Medical device
- How many people
- 4,060 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 24 Oct 2024to 3 Mar 2026
- 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 Up to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: All infants who are born to mothers in the catchment areas covered by PRISMA study sites
Who may be able to join
- All infants who are born to PRISMA enrolled mothers will be eligible for this study.
Who cannot join
- Presence of skin lesions, abnormalities, etc on the baby's nose, face, and ears, which could interfere with bilirubin measurement, as determined by research staff.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
India2 sites
Society for Applied Studies (SAS)
Hodal, India
Christian Medical College (CMC)
Vellore, India
Kenya1 site
Kenya Medical Research Institute - Center for Global Health Research
Kisumu, Kenya
Zambia1 site
University of North Carolina - Global Projects Zambia
Lusaka, Zambia
About this study
Official title: Multi-Country Evaluation of Bili-ruler, a Low-cost Icterometer for Screening of Jaundice in Newborns
Newborn jaundice, or accumulation of bilirubin molecules in blood, affects 60-80% of newborns and, in severe cases, places newborns at risk of brain damage and death. Universal screening of all newborn for jaundice ensures that at-risk newborns are identified and treated early. The bili-ruler is a low-cost ($10) plastic icterometer which could enable accurate and timely identification of jaundice in diverse settings.
The objective of this study is to evaluate the ability of bili-ruler to identify jaundiced newborns in their first week of life, compared to traditional methods of jaundice screening: visual inspection and transcutaneous bilirubinometry.
Read the detailed description
Neonatal jaundice, or accumulation of bilirubin molecules in blood, places newborns at risk of brain damage and death. Hyperbilirubinemia, or severe bilirubin levels above approximately 15 mg/dL, is a secondary outcome in the PRISMA MNH study. Newborn jaundice accounted for 13.09 deaths per 100,000 in 2016, and the burden is highest in South Asia and sub-Saharan Africa, where neonatal jaundice is the 7th and 8th leading cause of newborn mortality, respectively. Universal screening is recommended, but the standard of care, visual inspection of the skin and sclera, has a low sensitivity of 42%. Transcutaneous bilirubinometers are promising noninvasive, handheld tools, but they are expensive (> $3000) and inaccurate in newborns with darker skin. In low-and-middle-income countries, as well as in rural settings, guardians and clinicians often fail to identify at-risk newborns due to a lack of appropriate, affordable, and accurate screening tools. The bili-ruler is a $10 ruler with six shades of yellow, which could enable jaundice screening with high sensitivity in diverse settings such as homes, mobile clinics, and rural areas.
In this study, we will evaluate jaundice in newborns using three noninvasive techniques: bili-ruler, visual inspection, and transcutaneous bilirubinometry (a handheld device). The goals are to determine whether the six bili-ruler shades of yellow can be accurately correlated with bilirubin levels measured by a transcutaneous device, as well as to evaluate whether many users from various backgrounds can easily use bili-ruler to obtain comparable measurements. Additionally, limited evidence exists on the progression of jaundice and the performance of noninvasive screening tools in premature newborns and in newborns with various skin tones, especially darker skin tones. We seek to address this gap by utilizing an existing multi-site, international collaboration (the Pregnancy Risk, Infant Surveillance, and Measurement Alliance, or PRISMA) and enrolling large, diverse study populations. This study is nested in the PRISMA Maternal and Newborn Health (MNH) study, which is an open-cohort study that assesses pregnancy risk factors and associated maternal and infant outcomes in six study sites in five countries. All six study sites, located in Ghana, Zambia, Kenya, Pakistan, and India, will participate and collect bilirubin and jaundice-related data at four time points (0-3, 3-5, 5-7, and 7-14 days of life). The investigators will evaluate agreement between the three methods and agreement between bili-ruler measurements taken by two independent users. The investigators will additionally evaluate the impact of gestational age and skin tone on the accuracy of bili-ruler. Finally, the investigators will assess factors that influence bilirubin measurements.
- Conditions
- Jaundice, Neonatal, Neonatal Diseases and Abnormalities, Neonatal Hyperbilirubinemia, Screening Tool, Screening
- Being tested
- Bili-ruler
- Keywords
- Hyperbilirubinemia, Jaundice, Neonatology, Universal Screening, Cohort Study, Icterometry
- Medical subject headings
- Jaundice, Neonatal, Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Hyperbilirubinemia, Neonatal, Hyperbilirubinemia, Jaundice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bili-rulerDevice
The noninvasive test will be conducted by aligning the bili-ruler with the infant's nose and choosing the color on the ruler which most closely matches the yellow discoloration on the skin.
| Study group | Role | What they receive |
|---|---|---|
| Pakistan Cohort | Infants born to PRISMA-enrolled mothers in the Pakistan catchment area Receives: Device: Bili-ruler | |
| Kenya Cohort | Infants born to PRISMA-enrolled mothers in the Kenya catchment area Receives: Device: Bili-ruler | |
| Zambia Cohort | Infants born to PRISMA-enrolled mothers in the Zambia catchment area Receives: Device: Bili-ruler | |
| Vellore, India Cohort | Infants born to PRISMA-enrolled mothers in the Vellore, India catchment area Receives: Device: Bili-ruler | |
| Hodal, India Cohort | Infants born to PRISMA-enrolled mothers in the Hodal, India catchment area Receives: Device: Bili-ruler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilirubin
Bilirubin levels will be assessed using Bili-ruler and a transcutaneous bilirubinometer (the Mennin Medical BiliCare device) at 0-3 days of life.
Measured: 0-3 days of life
Bilirubin
Bilirubin levels will be assessed using Bili-ruler and a transcutaneous bilirubinometer (the Mennin Medical BiliCare device) at 3-5 days of life.
Measured: 3-5 days of life
Bilirubin
Bilirubin levels will be assessed using Bili-ruler and a transcutaneous bilirubinometer (the Mennin Medical BiliCare device) at 5-7 days of life.
Measured: 5-7 days of life
Secondary outcomes (3)
Jaundice
Jaundice will be evaluated using visual inspection of the skin and sclera of the newborn. We will define 'jaundice' as the presence of yellow discoloration on the newborn's forehead, and we will define 'severe jaundice' as the presence of yellow discoloration on the palms/soles.
Measured: 0-3 days of life
Jaundice
Jaundice will be evaluated using visual inspection of the skin and sclera of the newborn. We will define 'jaundice' as the presence of yellow discoloration on the newborn's forehead, and we will define 'severe jaundice' as the presence of yellow discoloration on the palms/soles.
Measured: 3-5 days of life
Jaundice
Jaundice will be evaluated using visual inspection of the skin and sclera of the newborn. We will define 'jaundice' as the presence of yellow discoloration on the newborn's forehead, and we will define 'severe jaundice' as the presence of yellow discoloration on the palms/soles.
Measured: 5-7 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start24 Oct 2024
- Primary completion3 Mar 2026
- Study completion3 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaundice, NeonatalStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- 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
- 4,060 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute, University of North Carolina, Chapel Hill, Aga Khan University, Christian Medical College, Vellore, India, Society for Applied Studies, Liverpool School of Tropical Medicine, United Kingdom
- Responsible party
- Principal investigator, Emily Smith, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687746
- Sponsor's protocol ID
- BILIRULER2024
- Status last verified
- May 2026
- First submitted
- 12 Nov 2024
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Country Evaluation of Bili-ruler, a Low-cost Icterometer for Screening of Jaundice in Newborns
- ClinicalTrials.gov ID
- NCT06687746
- Acronym / sponsor ID
- BILIRULER2024
- Conditions
- Jaundice, Neonatal, Neonatal Diseases and Abnormalities, Neonatal Hyperbilirubinemia, Screening Tool, Screening
- Keywords
- Hyperbilirubinemia, Jaundice, Neonatology, Universal Screening, Cohort Study, Icterometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,060 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute, University of North Carolina, Chapel Hill, Aga Khan University, Christian Medical College, Vellore, India, Society for Applied Studies, Liverpool School of Tropical Medicine, United Kingdom
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 3 Mar 2026 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 14 Nov 2024 (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.
Newborn jaundice, or accumulation of bilirubin molecules in blood, affects 60-80% of newborns and, in severe cases, places newborns at risk of brain damage and death. Universal screening of all newborn for jaundice ensures that at-risk newborns are identified and treated early. The bili-ruler is a low-cost ($10) plastic icterometer which could enable accurate and timely identification of jaundice in diverse settings.
The objective of this study is to evaluate the ability of bili-ruler to identify jaundiced newborns in their first week of life, compared to traditional methods of jaundice screening: visual inspection and transcutaneous bilirubinometry.
Detailed description
Neonatal jaundice, or accumulation of bilirubin molecules in blood, places newborns at risk of brain damage and death. Hyperbilirubinemia, or severe bilirubin levels above approximately 15 mg/dL, is a secondary outcome in the PRISMA MNH study. Newborn jaundice accounted for 13.09 deaths per 100,000 in 2016, and the burden is highest in South Asia and sub-Saharan Africa, where neonatal jaundice is the 7th and 8th leading cause of newborn mortality, respectively. Universal screening is recommended, but the standard of care, visual inspection of the skin and sclera, has a low sensitivity of 42%. Transcutaneous bilirubinometers are promising noninvasive, handheld tools, but they are expensive (> $3000) and inaccurate in newborns with darker skin. In low-and-middle-income countries, as well as in rural settings, guardians and clinicians often fail to identify at-risk newborns due to a lack of appropriate, affordable, and accurate screening tools. The bili-ruler is a $10 ruler with six shades of yellow, which could enable jaundice screening with high sensitivity in diverse settings such as homes, mobile clinics, and rural areas.
In this study, we will evaluate jaundice in newborns using three noninvasive techniques: bili-ruler, visual inspection, and transcutaneous bilirubinometry (a handheld device). The goals are to determine whether the six bili-ruler shades of yellow can be accurately correlated with bilirubin levels measured by a transcutaneous device, as well as to evaluate whether many users from various backgrounds can easily use bili-ruler to obtain comparable measurements. Additionally, limited evidence exists on the progression of jaundice and the performance of noninvasive screening tools in premature newborns and in newborns with various skin tones, especially darker skin tones. We seek to address this gap by utilizing an existing multi-site, international collaboration (the Pregnancy Risk, Infant Surveillance, and Measurement Alliance, or PRISMA) and enrolling large, diverse study populations. This study is nested in the PRISMA Maternal and Newborn Health (MNH) study, which is an open-cohort study that assesses pregnancy risk factors and associated maternal and infant outcomes in six study sites in five countries. All six study sites, located in Ghana, Zambia, Kenya, Pakistan, and India, will participate and collect bilirubin and jaundice-related data at four time points (0-3, 3-5, 5-7, and 7-14 days of life). The investigators will evaluate agreement between the three methods and agreement between bili-ruler measurements taken by two independent users. The investigators will additionally evaluate the impact of gestational age and skin tone on the accuracy of bili-ruler. Finally, the investigators will assess factors that influence bilirubin measurements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Pakistan Cohort | – | Device: Bili-rulerInfants born to PRISMA-enrolled mothers in the Pakistan catchment area |
| Kenya Cohort | – | Device: Bili-rulerInfants born to PRISMA-enrolled mothers in the Kenya catchment area |
| Zambia Cohort | – | Device: Bili-rulerInfants born to PRISMA-enrolled mothers in the Zambia catchment area |
| Vellore, India Cohort | – | Device: Bili-rulerInfants born to PRISMA-enrolled mothers in the Vellore, India catchment area |
| Hodal, India Cohort | – | Device: Bili-rulerInfants born to PRISMA-enrolled mothers in the Hodal, India catchment area |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All infants who are born to mothers in the catchment areas covered by PRISMA study sites
Key inclusion criteria (1 listed)
- All infants who are born to PRISMA enrolled mothers will be eligible for this study.
Key exclusion criteria (1 listed)
- Presence of skin lesions, abnormalities, etc on the baby's nose, face, and ears, which could interfere with bilirubin measurement, as determined by research staff.
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 |
|---|---|---|
| Bili-rulerThe noninvasive test will be conducted by aligning the bili-ruler with the infant's nose and choosing the color on the ruler which most closely matches the yellow discoloration on the skin. | Device | Hodal, India Cohort, Kenya Cohort, Pakistan Cohort, Vellore, India Cohort, Zambia Cohort |
Primary outcome
Bilirubin
Time frame: 0-3 days of life
Bilirubin levels will be assessed using Bili-ruler and a transcutaneous bilirubinometer (the Mennin Medical BiliCare device) at 0-3 days of life.
Bilirubin
Time frame: 3-5 days of life
Bilirubin levels will be assessed using Bili-ruler and a transcutaneous bilirubinometer (the Mennin Medical BiliCare device) at 3-5 days of life.
Bilirubin
Time frame: 5-7 days of life
Bilirubin levels will be assessed using Bili-ruler and a transcutaneous bilirubinometer (the Mennin Medical BiliCare device) at 5-7 days of life.
3 secondary outcomes
Jaundice
Time frame: 0-3 days of life
Jaundice
Time frame: 3-5 days of life
Jaundice
Time frame: 5-7 days of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Jaundice, Neonatal and Neonatal Diseases and Abnormalities, run by George Washington University at 5 sites in 4 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in India, Kenya, Pakistan, Zambia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bilirubin (time frame: 0-3 days of life). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2026.