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

Not Applicable

• Conditions: Newborn
• Interventions: Procedure: Umbilical cord blood and hair collection

• Registration Number: NCT03630575
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-06
• Study First Submitted QC: 2018-08-10
• Study First Posted: 2018-08-15
• Last Update Submitted: 2018-08-30
• Last Update Posted: 2018-08-31
• Study Start: 2018-09-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Newborns exposed in-utero to psychoactive substances	Umbilical cord blood and hair collection	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hôpital Archet 2 - Service de Gynécologie - Obstétrique - Reproduction; 🇫🇷 Nice, France