NewbornNBHSNCT03630575
Study of Psychoactive Substances in Newborns' Hair Whose Mothers Were Treated and Followed at the Nice University Hospital - New Born Hair Study
A study testing Umbilical cord blood and hair collection in people with Newborn, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Newborn
- What is being tested?
- Umbilical cord blood and hair collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2018to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site
Hôpital Archet 2 - Service de Gynécologie - Obstétrique - Reproduction
Nice, 06200
About this study
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.
Read more
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
- Being tested
- Umbilical cord blood and hair collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord blood and hair collectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Newborns exposed in-utero to psychoactive substances | Experimental | Not described Receives: Procedure: Umbilical cord blood and hair collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start1 Sep 2018 (estimated)
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Mar 2020 (estimated)
Why it stopped: The investigator never responded to requests for changes from the ethics committee.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NewbornStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- André BONGAIN, PU-PH, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630575
- Sponsor's protocol ID
- 16-PP-01
- Acronym
- NBHS
- Status last verified
- Nov 2025
- First submitted
- 6 Aug 2018
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Psychoactive Substances in Newborns' Hair Whose Mothers Were Treated and Followed at the Nice University Hospital - New Born Hair Study
- ClinicalTrials.gov ID
- NCT03630575
- Acronym / sponsor ID
- NBHS / 16-PP-01
- Conditions
- Newborn
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The investigator never responded to requests for changes from the ethics committee.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newborns exposed in-utero to psychoactive substances | Experimental | Procedure: Umbilical cord blood and hair collection |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Umbilical cord blood and hair collectionAt 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. | Procedure or surgery | Newborns exposed in-utero to psychoactive substances |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
André BONGAIN, PU-PH principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Umbilical cord blood and hair collection in people with Newborn, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of psychoactive substances concentration in newborn's hair at 6 months (time frame: At 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.