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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-7
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Having received phototherapy treatment within the last 24 hours

Trial population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Skin color assessment

    Procedure/Surgery

    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.

Treatment groups

510 Participants
are divided into 1 treatment group
Group A: Study population1 intervention

Trial outcomes

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

Time frame
First two days of life

Secondary outcomes

1

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

Correlation coefficients between transcutaneous bilirubin and serum bilirubin in the three skin pigmentation groups (light, intermediate, dark)

Time frame
1 to 7 days
2

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

First measurement of transcutaneous and serum bilirubin performed during newborn follow-up

Time frame
First two days of life
3

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

Positive predictive value (PPV) of the current screening method-based on a common nomogram for all newborns and jaundice risk factors-according to skin pigmentation level and in the overall population

Time frame
1 to 7 days
4

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

Rate of invasive blood samples performed in newborns with physiological serum bilirubin levels, according to skin pigmentation level and in the overall population

Time frame
1 to 7 days

Other outcomes

Sponsors and contacts

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Assistance Publique - Hôpitaux de Paris

Lead sponsor

URC-CIC Paris Descartes Necker Cochin

Collaborator

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