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

NCT07315126 | Not Yet Recruiting

• 2 other identifiers: APHP251268IDRCB
• Study Type: observational
• Target: 510
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neonatal Jaundice

Keywords

Neonatal jaundice; Kernicterus; Newborn

Outcome Measures

Primary Outcomes (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

  Based on the first transcutaneous and serum bilirubin assessments

  First two days of life

Secondary Outcomes (6)

• To evaluate whether the reliability of transcutaneous bilirubin measurements differs between newborns with dark or intermediate skin phototypes and those with light skin phototyp

  1 to 7 days

• To compare transcutaneous and serum bilirubin values within each skin pigmentation group and across the overall population

  First two days of life

• To estimate the probability that a positive screening result truly corresponds to jaundice in the newborn, according to the degree of skin pigmentation and in the overall population

  1 to 7 days

• To determine, according to the degree of skin pigmentation and in the overall population, the number of invasive blood samples performed due to an overestimation of transcutaneous bilirubin when serum bilirubin levels were within physiological ranges

  1 to 7 days

• To determine, in newborns with intermediate or dark phototypes, based on the specific nomograms published in 2017 and integrated into the screening algorithm, the number of invasive blood samples avoided, and to specify whether these cases actually corre

  1 to 7 days

Study Arms (1)

Study population

Single-arm study including 510 patients meeting identical inclusion and exclusion criteria and receiving the same intervention. All participants are enrolled in one study group. Subgroup analyses according to Fitzpatrick skin phototype are planned and are described in the Detailed Description section.

Procedure: Skin color assessment

Interventions

Skin color assessment PROCEDURE

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 population

Eligibility Criteria

• Age: 1 Hour - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Newborns from 36 weeks of amenorrhea hospitalized in the postnatal ward or in the kangaroo unit within the Port-Royal maternity.

You may qualify if:

• 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.

You may not qualify if:

• Having received phototherapy treatment within the last 24 hours

Sponsors & Collaborators

• URC-CIC Paris Descartes Necker Cochin: collaborator
• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Maternité Port Royal

Paris, 75014, France

Location

MeSH Terms

Conditions

Jaundice, Neonatal; Kernicterus

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Erythroblastosis, Fetal; Hematologic Diseases; Hemic and Lymphatic Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Immune System Diseases

Central Study Contacts

Harmony PLACERDAT

CONTACT

07 61 67 30 15; harmony.placerdat@aphp.fr

Aline DECHANET

CONTACT

aline.dechanet@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 2, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)