Reliability of Transcutaneous Bilirubin Measurement According to the Skin Colour of Newborns
Condition(s) studied
Investigational drug(s) / intervention(s)
Skin color assessment: Each participant's skin color is evaluated according to the Fitzpatrick skin type classification. All other care is standard, and no additional treatment is administered.
Study 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.
Eligibility
Primary outcome measure(s)
- 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 — First two days of life
Based on the first transcutaneous and serum bilirubin assessments
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Maternité Port Royal | Paris | France |
More Assistance Publique - Hôpitaux de Paris trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07315126 on ClinicalTrials.gov ↗ ← All trials in France