Clinical trial NCT06687746: Evaluation of Bili-ruler, a Low-cost, Plastic Icterometer for Community-based Screening of Jaundice in Newborns
Official title: Multi-Country Evaluation of Bili-ruler, a Low-cost Icterometer for Screening of Jaundice in Newborns
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Jaundice, Neonatal
Neonatal Diseases and Abnormalities
Neonatal Hyperbilirubinemia
Screening Tool
Screening
Keywords: Hyperbilirubinemia
Jaundice
Neonatology
Universal Screening
Cohort Study
Icterometry
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: Kenya Medical Research Institute
name: University of North Carolina, Chapel Hill
name: Kintampo Health Research Centre, Ghana
name: Aga Khan University
name: Christian Medical College, Vellore, India
name: Society for Applied Studies
name: Liverpool School of Tropical Medicine, United Kingdom
name: University of Ghana
name: University of North Carolina Global Project Zambia
First posted: 2024-11-14
Enrollment: 5400
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All infants who are born to mothers in the catchment areas covered by PRISMA study sites

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bilirubin
timeFrame: 0-3 days of life
measure: Bilirubin
timeFrame: 3-5 days of life
measure: Bilirubin
timeFrame: 5-7 days of life
Secondary outcomes:
measure: Jaundice
timeFrame: 0-3 days of life
measure: Jaundice
timeFrame: 3-5 days of life
measure: Jaundice
timeFrame: 5-7 days of life
Other outcomes:
Locations:
city: Kintampo
country: Ghana
facility: Kintampo Health Research Centre
city: Hodal
country: India
facility: Society for Applied Studies (SAS)
city: Vellore
country: India
facility: Christian Medical College (CMC)
city: Kisumu
country: Kenya
facility: Kenya Medical Research Institute - Center for Global Health Research
city: Karachi
country: Pakistan
facility: Aga Khan University
city: Lusaka
country: Zambia
facility: University of North Carolina - Global Projects Zambia
Study officials:
References: