Evaluation of Bili-ruler, a Low-cost, Plastic Icterometer for Community-based Screening of Jaundice in Newborns

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.

Study Overview

• Status: Completed
• Conditions: Neonatal Hyperbilirubinemia; Jaundice, Neonatal; Screening; Neonatal Diseases and Abnormalities; Screening Tool
• Intervention / Treatment: Device: Bili-ruler

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 Type: Observational
• Enrollment (Actual): 4060

Contacts and Locations

Study Locations

• India
  • India
    • Hodal, India, India
      • Society for Applied Studies (SAS)
    • Vellore, India, India
      • Christian Medical College (CMC)
• Kenya
  • Kenya
    • Kisumu, Kenya, Kenya
      • Kenya Medical Research Institute - Center for Global Health Research
• Pakistan
  • Pakistan
    • Karachi, Pakistan, Pakistan
      • Aga Khan University
• Zambia
  • Zambia
    • Lusaka, Zambia, Zambia
      • University of North Carolina - Global Projects Zambia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All infants who are born to mothers in the catchment areas covered by PRISMA study sites

Description

Inclusion Criteria:

• All infants who are born to PRISMA enrolled mothers will be eligible for this study.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pakistan Cohort; Infants born to PRISMA-enrolled mothers in the Pakistan 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.
Kenya Cohort; Infants born to PRISMA-enrolled mothers in the Kenya 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.
Zambia Cohort; Infants born to PRISMA-enrolled mothers in the Zambia 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.
Vellore, India Cohort; Infants born to PRISMA-enrolled mothers in the Vellore, 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.
Hodal, India Cohort; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bilirubin	Bilirubin levels will be assessed using Bili-ruler and a transcutaneous bilirubinometer (the Mennin Medical BiliCare device) at 0-3 days of life.	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.	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.	5-7 days of life

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	5-7 days of life

Collaborators and Investigators

• Sponsor: George Washington University
• Collaborators: University of North Carolina, Chapel Hill; Aga Khan University; Kenya Medical Research Institute; Christian Medical College, Vellore, India; Society for Applied Studies; Liverpool School of Tropical Medicine, United Kingdom

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2024
• Primary Completion (Actual): March 3, 2026
• Study Completion (Actual): March 3, 2026

Study Registration Dates

• First Submitted: November 12, 2024
• First Submitted That Met QC Criteria: November 12, 2024
• First Posted (Actual): November 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Jaundice; Cohort Study; Hyperbilirubinemia; Neonatology; Universal Screening; Icterometry
• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Skin Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Jaundice, Neonatal; Jaundice; Hyperbilirubinemia, Neonatal; Hyperbilirubinemia; Congenital, Hereditary, and Neonatal Diseases and Abnormalities
• Other Study ID Numbers: BILIRULER2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No