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

NCT03630575 | Withdrawn

• 1 other identifier: 16-PP-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Newborn

Outcome Measures

Primary Outcomes (1)

• Change of psychoactive substances concentration in newborn's hair 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.

  At 6 Months

Study Arms (1)

Newborns exposed in-utero to psychoactive substances

EXPERIMENTAL

Procedure: Umbilical cord blood and hair collection

Interventions

Umbilical cord blood and hair collection 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.

Newborns exposed in-utero to psychoactive substances

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Hôpital Archet 2 - Service de Gynécologie - Obstétrique - Reproduction

Nice, 06200, France

Location

Study Officials

• André BONGAIN, PU-PH

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 15, 2018
• Study Start: September 1, 2018
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

FR (1)