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

Newborn Clinical Trial

— NBHS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03630575
• Other study ID #: 16-PP-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire de Nice
• Contact: André BONGAIN, PU-PH
• Phone: +33 (0)4.92.03.61.05
• Email: bongain.a[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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.

Related Conditions & MeSH terms

• Newborn

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Archet 2 - Service de Gynécologie - Obstétrique - Reproduction	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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