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

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ClinicalTrials.gov Identifier: NCT03630575
Recruitment Status : Not yet recruiting
First Posted : August 15, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Newborn Procedure: Umbilical cord blood and hair collection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Study of Psychoactive Substances in Newborns' Hair Whose Mothers Were Treated and Followed at the Nice University Hospital - New Born Hair Study
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Newborns exposed in-utero to psychoactive substances 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.




Primary Outcome Measures :
  1. Change of psychoactive substances concentration in newborn's hair at 6 months [ Time Frame: 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.



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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630575


Contacts
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Contact: André BONGAIN, PU-PH +33 (0)4.92.03.61.05 bongain.a@chu-nice.fr

Locations
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France
Hôpital Archet 2 - Service de Gynécologie - Obstétrique - Reproduction Not yet recruiting
Nice, France, 06200
Contact: André BONGAIN, PU-PH    +33 (0)4.92.03.61.05      
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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Principal Investigator: André BONGAIN, PU-PH Centre Hospitalier Universitaire de Nice

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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT03630575     History of Changes
Other Study ID Numbers: 16-PP-01
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No