Newborn
Conditions
Brief summary
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.
Interventions
PROCEDUREUmbilical 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.
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No
Inclusion criteria
* Newborns of mothers treated with known doses of psychoactive drugs during pregnancy or exposed to cannabinoids during pregnancy * Full-term newborns (≥37 weeks) * Informed consent signed by the child's legal representatives * Affiliation to Social Security
Exclusion criteria
* Newborns of mothers exposed to unknown doses of psychoactive substances (excluding cannabis) during pregnancy * One of the child's legal representatives hasn't signed the informed consent * Premature delivery \<37 weeks of amenorrhea * Newborns who can't be followed at T 4-6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of psychoactive substances concentration in newborn's hair at 6 months | 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. |
Countries
France
Outcome results
None listed