An interventional study of Umbilical cord blood and hair collection in Newborn, sponsored by Centre Hospitalier Universitaire de Nice. Withdrawn at 1 site in France. Open to participants aged Up to 6 Months. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Other
Hair toxicological analysis is nowadays a complementary technique to blood and urinary analyses because it allows a better detection of xenobiotics in time.
The detection of xenobiotics is expressed in hours in blood and in days in urines; it is several months in the hair. So, hair makes it possible to establish a retrospective timetable of consumption and exposure to xenobiotics.
In newborns, hair has different morphological characteristics than adults' hair. It is thinner, more porous and the development phases are not the same.
Nevertheless, it is recognized that the absorption mechanisms of xenobiotics in newborns' hair are similar to those of adults. On the other hand, some difficulties of interpretation and discernment are observed between in utero exposure and environmental exposure after birth.
It is interesting to have data to estimate the absorption of psychoactive substances in newborns' hair following an utero exposure.
The main objective of this project is to study the mechanisms of incorporation of psychoactive substances administered to the mothers during pregnancy in newborns' hair.
Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.
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Procedure: Umbilical cord blood and hair collection
At the birth of the newborn, a first hair sample and a cord blood sample will be taken. A follow-up of the newborn will be performed between 4 and 6 months in order to obtain a second hair sample.
Change of psychoactive substances concentration in newborn's hair at 6 months
The primary outcome measure is the presence of at least one molecule from the following classes of drugs (antidepressants, opioids, cannabinoids, anti-epileptics, benzodiazepines), on at least one of the hair segments studied, at a minimum concentration corresponding to the limit of quantification of the analytical technique.
Time frame: At 6 Months
This study is withdrawn, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nice