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ACTIVE NOT RECRUITING
NCT06687746

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

Sponsor: George Washington University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - 28 Days

Study Type

OBSERVATIONAL

Enrollment

5400

Start Date

2024-10-24

Completion Date

2026-04-01

Last Updated

2026-02-05

Healthy Volunteers

Yes

Interventions

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.

Locations (6)

Kintampo Health Research Centre

Kintampo, Ghana, Ghana

Society for Applied Studies (SAS)

Hodal, India, India

Christian Medical College (CMC)

Vellore, India, India

Kenya Medical Research Institute - Center for Global Health Research

Kisumu, Kenya, Kenya

Aga Khan University

Karachi, Pakistan, Pakistan

University of North Carolina - Global Projects Zambia

Lusaka, Zambia, Zambia