Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT03630575

Study of Psychoactive Substances in Newborns' Hair Whose Mothers Were Treated and Followed at the Nice University Hospital - New Born Hair Study

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Centre Hospitalier Universitaire de Nice · Academic / Other
Sex
All
Age
6 Months
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREUmbilical cord blood and hair collectionAt 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.

Timeline

Start date
2018-09-01
Primary completion
2020-03-01
Completion
2020-03-01
First posted
2018-08-15
Last updated
2025-12-02

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03630575. Inclusion in this directory is not an endorsement.