Multi-Country Evaluation of Bili-ruler, a Low-cost Icterometer for Screening of Jaundice in Newborns

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 28 days
Healthy Volunteers: t
View:

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

Locations
Other Locations
Ghana
Kintampo Health Research Centre
NOT_YET_RECRUITING
Kintampo
India
Society for Applied Studies (SAS)
RECRUITING
Hodal
Christian Medical College (CMC)
RECRUITING
Vellore
Kenya
Kenya Medical Research Institute - Center for Global Health Research
RECRUITING
Kisumu
Pakistan
Aga Khan University
RECRUITING
Karachi
Zambia
University of North Carolina - Global Projects Zambia
RECRUITING
Lusaka
Contact Information
Primary
Emily R Smith, ScD, MPH
emilysmith@gwu.edu
12029943589
Backup
Jaime Marquis, MPH
jmarquis@gwu.edu
Time Frame
Start Date: 2024-10-24
Estimated Completion Date: 2025-12
Participants
Target number of participants: 5400
Treatments
Pakistan Cohort
Infants born to PRISMA-enrolled mothers in the Pakistan catchment area
Kenya Cohort
Infants born to PRISMA-enrolled mothers in the Kenya catchment area
Ghana Cohort
Infants born to PRISMA-enrolled mothers in the Ghana catchment area
Zambia Cohort
Infants born to PRISMA-enrolled mothers in the Zambia catchment area
Vellore, India Cohort
Infants born to PRISMA-enrolled mothers in the Vellore, India catchment area
Hodal, India Cohort
Infants born to PRISMA-enrolled mothers in the Hodal, India catchment area
Sponsors
Collaborators: University of Ghana, Kintampo Health Research Centre, Ghana, Christian Medical College, Vellore, India, Kenya Medical Research Institute, Aga Khan University, Liverpool School of Tropical Medicine, United Kingdom, Society for Applied Studies, University of North Carolina Global Project Zambia, University of North Carolina, Chapel Hill
Leads: George Washington University

This content was sourced from clinicaltrials.gov