Ireland
--:--IST
Starting soon Observational

Reliability of Transcutaneous Bilirubin Measurement According to the Skin Colour of Newborns

NCT07315126 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2026-03
Last updated
2026-01-02

Condition(s) studied

Neonatal Jaundice

Investigational drug(s) / intervention(s)

Skin color assessment

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

Sex
ALL
Min age
1 Hour
Max age
7 Days
Healthy volunteers
No
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

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)

FacilityCityRegionStatus
Maternité Port Royal Paris France
Official registry record

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