NCT06687746

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,060

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2024

Geographic Reach
4 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2024

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2026

Completed
Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

1.4 years

First QC Date

November 12, 2024

Last Update Submit

May 26, 2026

Conditions

Jaundice, NeonatalNeonatal Diseases and AbnormalitiesNeonatal HyperbilirubinemiaScreening ToolScreening

Keywords

HyperbilirubinemiaJaundiceNeonatologyUniversal ScreeningCohort StudyIcterometry

Outcome Measures

Primary Outcomes (3)

  • Bilirubin

    Bilirubin levels will be assessed using Bili-ruler and a transcutaneous bilirubinometer (the Mennin Medical BiliCare device) at 0-3 days of life.

    0-3 days of life

  • Bilirubin

    Bilirubin levels will be assessed using Bili-ruler and a transcutaneous bilirubinometer (the Mennin Medical BiliCare device) at 3-5 days of life.

    3-5 days of life

  • Bilirubin

    Bilirubin levels will be assessed using Bili-ruler and a transcutaneous bilirubinometer (the Mennin Medical BiliCare device) at 5-7 days of life.

    5-7 days of life

Secondary Outcomes (3)

  • Jaundice

    0-3 days of life

  • Jaundice

    3-5 days of life

  • Jaundice

    5-7 days of life

Study Arms (5)

Pakistan Cohort

Infants born to PRISMA-enrolled mothers in the Pakistan catchment area

Device: Bili-ruler

Kenya Cohort

Infants born to PRISMA-enrolled mothers in the Kenya catchment area

Device: Bili-ruler

Zambia Cohort

Infants born to PRISMA-enrolled mothers in the Zambia catchment area

Device: Bili-ruler

Vellore, India Cohort

Infants born to PRISMA-enrolled mothers in the Vellore, India catchment area

Device: Bili-ruler

Hodal, India Cohort

Infants born to PRISMA-enrolled mothers in the Hodal, India catchment area

Device: Bili-ruler

Interventions

Bili-rulerDEVICE

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.

Hodal, India CohortKenya CohortPakistan CohortVellore, India CohortZambia Cohort

Eligibility Criteria

AgeUp to 28 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All infants who are born to mothers in the catchment areas covered by PRISMA study sites

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Society for Applied Studies (SAS)

Hodal, India, India

Location

Christian Medical College (CMC)

Vellore, India, India

Location

Kenya Medical Research Institute - Center for Global Health Research

Kisumu, Kenya, Kenya

Location

Aga Khan University

Karachi, Pakistan, Pakistan

Location

University of North Carolina - Global Projects Zambia

Lusaka, Zambia, Zambia

Location

MeSH Terms

Conditions

Jaundice, NeonatalCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperbilirubinemia, NeonatalHyperbilirubinemiaJaundice

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 12, 2024

First Posted

November 14, 2024

Study Start

October 24, 2024

Primary Completion

March 3, 2026

Study Completion

March 3, 2026

Last Updated

May 28, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

KE(1)PA(1)ZA(1)IN(2)