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NOT YET RECRUITING
NCT07315126

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

1 Hour - 7 Days

Study Type

OBSERVATIONAL

Enrollment

510

Start Date

2026-03

Completion Date

2027-04

Last Updated

2026-01-02

Healthy Volunteers

No

Interventions

PROCEDURE

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.

Locations (1)

Maternité Port Royal

Paris, France