Study of Psychoactive Substances in Newborns' Hair Whose Mothers Were Treated and Followed at the Nice University Hospital - New Born Hair Study (NBHS)
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|ClinicalTrials.gov Identifier: NCT03630575|
Recruitment Status : Not yet recruiting
First Posted : August 15, 2018
Last Update Posted : August 31, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Newborn||Procedure: Umbilical cord blood and hair collection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Psychoactive Substances in Newborns' Hair Whose Mothers Were Treated and Followed at the Nice University Hospital - New Born Hair Study|
|Estimated Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||March 1, 2020|
|Estimated Study Completion Date :||March 1, 2020|
|Experimental: Newborns exposed in-utero to psychoactive substances||
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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630575
|Contact: André BONGAIN, PU-PH||+33 (0)firstname.lastname@example.org|
|Hôpital Archet 2 - Service de Gynécologie - Obstétrique - Reproduction||Not yet recruiting|
|Nice, France, 06200|
|Contact: André BONGAIN, PU-PH +33 (0)4.92.03.61.05|
|Principal Investigator:||André BONGAIN, PU-PH||Centre Hospitalier Universitaire de Nice|