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

Not yet recruiting

• Conditions: Jaundice, Neonatal; Neonatal Diseases and Abnormalities; Neonatal Hyperbilirubinemia; Screening Tool; Screening

• Registration Number: NCT06687746
• Lead Sponsor: George Washington University

Brief 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. 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 Timeline

• Status Verified: 2024-11
• Study Start: 2024-11
• Study First Submitted: 2024-11-12
• Study First Submitted QC: 2024-11-12
• Last Update Submitted: 2024-11-12
• Study First Posted: 2024-11-14
• Last Update Posted: 2024-11-14
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bilirubin	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.

Secondary Outcome Measures

Name	Time	Method
Jaundice	5-7 days of life	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.

Trial Locations

Locations (6)

Kintampo Health Research Centre; 🇬🇭 Kintampo, Ghana

Society for Applied Studies (SAS); 🇮🇳 Hodal, India

Christian Medical College (CMC); 🇮🇳 Vellore, India

Kenya Medical Research Institute - Center for Global Health Research; 🇰🇪 Kisumu, Kenya

Aga Khan University; 🇵🇰 Karachi, Pakistan

University of North Carolina - Global Projects Zambia; 🇿🇲 Lusaka, Zambia