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

C

Centre Hospitalier Universitaire de Nice

Status

Unknown

Conditions

Newborn

Treatments

Procedure: Umbilical cord blood and hair collection

Study type

Interventional

Funder types

Other

Identifiers

NCT03630575
16-PP-01

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

Under 6 months old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Newborns exposed in-utero to psychoactive substances
Experimental group
Treatment:
Procedure: Umbilical cord blood and hair collection

Trial contacts and locations

1

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Central trial contact

André BONGAIN, PU-PH

Data sourced from clinicaltrials.gov

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