Evaluation of Bili-ruler, a Low-cost, Plastic Icterometer for Community-based Screening of Jaundi… (NCT06687746) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Bili-ruler, a Low-cost, Plastic Icterometer for Community-based Screening of Jaundice in Newborns
India, Kenya, Pakistan4,060 participantsStarted 2024-10-24
Plain-language 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.
Who can participate
Age range
28 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.