Reliability of Transcutaneous Bilirubin Measurement According to the Skin Colour of Newborns (NCT07315126) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Reliability of Transcutaneous Bilirubin Measurement According to the Skin Colour of Newborns
France510 participantsStarted 2026-03
Plain-language summary
Neonatal jaundice is a physiological process characterized by a yellow coloration of the skin and mucous membranes linked to an increase in a pigment: bilirubin. However, an excessive accumulation of bilirubin can lead to neurological complications: kernicterus. The screening for pathological jaundice is carried out through daily measurements of transcutaneous bilirubin using non-invasive devices (bilirubinometers). The diagnosis is made by measuring blood bilirubin levels and comparing them with reference curves. In newborns with dark skin, transcutaneous bilirubin measurements may be inaccurate because melanin interferes with the bilirubinometers.
Who can participate
Age range
1 Hour – 7 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:
* Born from 36 weeks of amenorrhea
* Hospitalized in the postnatal ward or kangaroo care unit
* Requiring a blood test for bilirubin analysed at the Cochin laboratory.
* No objection from both holders of parental authority.
Exclusion Criteria:
* Having received phototherapy treatment within the last 24 hours
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.
What they're measuring
1
To evaluate the reliability of transcutaneous bilirubin measurements performed routinely with a new-generation bilirubinometer to screen for jaundice according to the degree of skin pigmentation of newborns, determined using a published scale, the Fitzpa