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

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.

Conditions

• Jaundice, Neonatal
• Neonatal Diseases and Abnormalities
• Neonatal Hyperbilirubinemia
• Screening Tool
• Screening

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.

Sponsors & Collaborators

• Kenya Medical Research Institute

  collaborator OTHER

• University of North Carolina, Chapel Hill

  collaborator OTHER

• Kintampo Health Research Centre, Ghana

  collaborator OTHER

• Aga Khan University

  collaborator OTHER

• Christian Medical College, Vellore, India

  collaborator OTHER

• Society for Applied Studies

  collaborator OTHER

• Liverpool School of Tropical Medicine, United Kingdom

  collaborator UNKNOWN

• University of Ghana

  collaborator OTHER

• University of North Carolina Global Project Zambia

  collaborator UNKNOWN

• George Washington University

  lead OTHER

Eligibility

Max Age

28 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-10-24

Primary Completion

2026-04-01

Completion

2026-04-01

Countries

• Ghana
• India
• Kenya
• Pakistan
• Zambia

Study Locations