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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2020-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Newborn

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Newborns exposed in-utero to psychoactive substances

Group Type EXPERIMENTAL

Umbilical cord blood and hair collection

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No