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

NCT ID: NCT07315126

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 510 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-03-31
• Study Completion Date: 2027-04-30

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.

Detailed Description

Neonatal jaundice is a physiological process characterized by a yellow coloration of the skin and mucous membranes. It is caused by an accumulation of bilirubin in the blood. Bilirubin is a product of haemolysis, the breakdown of haem. It circulates in the blood bound to albumin. The unconjugated fraction that is not bound to albumin is neurotoxic. This physiological process must be monitored because free bilirubin is neurotoxic. Due to the immaturity of the blood-brain barrier, it can cross into the brain and damage the basal ganglia. In this case, the condition is referred to as kernicterus, which can cause acute and then chronic encephalopathies, leading to neurosensory disorders and disability in children.

Prevention of kernicterus relies on the detection of excessively high bilirubin concentrations. However, diagnosis requires an invasive blood sample to measure serum bilirubin level. Clinical screening based on the color of the newborn's skin and eyes is insufficient and must be complemented by non-invasive photometric screening using a transcutaneous bilirubinometer (a light flash on the skin). The device estimates the level of bilirubin in the blood. Measurements are performed daily by midwives during the mother and newborn's stay in the maternity ward within the first 3 to 5 days after birth. Unfortunately, the reliability of this screening appears to be lower in newborns with darker skin tones.

Between 2011 and 2012, the National Reference Center for Perinatal Hemobiology (CNRHP) recorded five cases of kernicterus in France, two of which involved delayed screening due to the newborns' dark skin. In both cases, an exchange transfusion (the last-resort treatment) had to be performed. In 2019, N'Guessan et al. reported a similar case in which, despite the presence of jaundice risk factors and a transcutaneous bilirubin level above the alert threshold, the medical team was reassured and concluded that the high reading was a discrepancy related to the infant's dark skin, without performing a confirmatory blood test.

Although most studies show a good correlation between transcutaneous bilirubin (TcB) and serum bilirubin (TSB) levels, they all report an overestimation of TcB values in newborns with darker skin. This does not generally compromise the detection of severe jaundice but may lead to a greater number of invasive blood samples to verify the results.

The methodology of most of these studies is questionable, as they refer to older-generation photometric devices, or use unvalidated colorimetric scales, and sometimes even subjective clinical assessments to determine skin color.

In 2017, a study including 6,373 preterm African-American newborns proposed a specific transcutaneous bilirubin nomogram for dark-skinned infants, with adjusted thresholds for BiliCheck© and JM-103© devices. However, these specific curves have never been externally validated and are therefore not used in routine clinical practice.

The question of the reliability of transcutaneous bilirubin measurements for jaundice screening according to skin color thus remains highly relevant.

To increase knowledge on the subject, it seems necessary to us to carry out a rigorous study of the reliability of transcutaneous bilirubin measurements performed routinely with a new-generation bilirubinometer for the screening of jaundice according to skin color. The children will be classified into three skin color groups using the Fitzpatrick classification: light skin, intermediate skin, and dark skin.

Conditions

Neonatal Jaundice

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Skin color assessment

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 1 Hour
• Maximum Eligible Age: 7 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Locations

Maternité Port Royal

Paris, , France

Countries

France

Central Contacts

Harmony PLACERDAT

Role: CONTACT

harmony.placerdat@aphp.fr

07 61 67 30 15 ext. +33

Aline DECHANET

Role: CONTACT

aline.dechanet@aphp.fr

Facility Contacts

Harmony PLACERDAT

Role: primary

harmony.placerdat@aphp.fr

07 61 67 30 15 ext. +33

Other Identifiers

IDRCB

Identifier Type: OTHER

Identifier Source: secondary_id

APHP251268

Identifier Type: -

Identifier Source: org_study_id