An observational study in Jaundice, Neonatal, Neonatal Diseases and Abnormalities and Neonatal Hyperbilirubinemia, sponsored by George Washington University. Completed at 5 sites in 4 countries. Open to participants aged Up to 28 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by George Washington University · Observational
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.
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.
110 studies on the registry are indexed under Jaundice, Neonatal; 28 are open to participants now.
This study's enrollment of 4,060 is above the median of 405 across 27 observational studies indexed under Jaundice, Neonatal.
Browse Jaundice, Neonatal studies →George Washington University is the lead sponsor of 192 studies on the registry; 34 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.
Counted across the registry records on this site, refreshed daily.
All infants who are born to mothers in the catchment areas covered by PRISMA study sites
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.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Infants born to PRISMA-enrolled mothers in the Pakistan catchment area
Device: Bili-ruler
Infants born to PRISMA-enrolled mothers in the Kenya catchment area
Device: Bili-ruler
Infants born to PRISMA-enrolled mothers in the Zambia catchment area
Device: Bili-ruler
Infants born to PRISMA-enrolled mothers in the Vellore, India catchment area
Device: Bili-ruler
Infants born to PRISMA-enrolled mothers in the Hodal, India catchment area
Device: Bili-ruler
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.
Bilirubin
Bilirubin levels will be assessed using Bili-ruler and a transcutaneous bilirubinometer (the Mennin Medical BiliCare device) at 0-3 days of life.
Time frame: 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.
Time frame: 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.
Time frame: 5-7 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.
Time frame: 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.
Time frame: 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.
Time frame: 5-7 days of life
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2024 to primary completion in Mar 2026, 16 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
George Washington University →