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 volunteersQualifiers
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
Case-only
Prospective
Treatments tested in this trial
Skin color assessment
Procedure/SurgeryEach 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
Trial outcomes
Primary outcomes
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
Secondary outcomes
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)
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
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
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
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Assistance Publique - Hôpitaux de Paris
Lead sponsor
URC-CIC Paris Descartes Necker Cochin
Collaborator
This trial is not recruiting at the moment. You can still explore other options: