Pregnancy RelatedNCT03047967
Effects of Prenatal Tobacco Smoke Exposure on Lung Function and Respiratory Epithelium Functionality in Newborns
A study testing lung function tests and Nasal brushing in people with Pregnancy Related and Tobacco Smoking, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Despite public campaigns to prevent cigarette smoking, it's about 20% of women who keep on smoking during pregnancy, exposing their fetus to prenatal tobacco adverse effects. Although environnemental tobacco smoke exposure effects are well known, consequences of prenatal tobacco smoke exposure (PTSE) need better… Read more about this study
- Who is it for?
- Ages 2 to 6 daysHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Tobacco Smoking, Lung Smokers
- What is being tested?
- lung function tests and Nasal brushing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 10 Nov 2017to 9 Feb 2019
- 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 2 to 6 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- inborn full-term neonate
- social security affiliation
- informed consent form signed by parents
Who cannot join
- prematurity < 35GW
- gemellary pregnancy
- Birth weight < 2200 g
- neonatal respiratory distress syndrome (nasal oxygenotherapy > 24 hours, invasive or noninvasive ventilation)
- neonatal malformation with conséquences on lung function
- neonatal liver or renal failure
Show all 12Show fewer
- high risk of heritable lung disease
- contra-indication to saccharose or paracetamol antalgic use
- language barrier,
- mother refusal to declare or precise her tobacco consumption
- no social security cover
- informed consent form not signed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effets du Tabagisme in Utero Sur la fonctionnalité de l'épithelium Respiratoire et Sur la Fonction Ventilatoire du Nouveau-né.
Despite public campaigns to prevent cigarette smoking, it's about 20% of women who keep on smoking during pregnancy, exposing their fetus to prenatal tobacco adverse effects. Although environnemental tobacco smoke exposure effects are well known, consequences of prenatal tobacco smoke exposure (PTSE) need better caracterization. Previous animal study from our group have shown, in prenatal nicotine exposed mouse pups, alterations in tracheal epithelial structure similar to those observed in KO α7-nAChR mouse pups. These findings support the hypothesis that α7-nAChR are involved in the process of deleterious effects of tobacco smoking on respiratory epithelium development. The purpose of the present clinical study is to compare PTSE neonates with controls according to lung function and respiratory epithelial functionality. At the age of 3 days, small respiratory epithelium fragments will be obtained from gentle nasal brushing performed under antalgic premedication according to the method we previously published. Epithelium samples will be used for in vitro studies of α7-nAChR and CFTR functionality. Between the ages of 2 and 6 weeks, lung function testing will be performed, by means of baby-body plethysmography.
- Conditions
- Pregnancy Related, Tobacco Smoking, Lung Smokers, Newborn
- Being tested
- lung function tests, Nasal brushing
- Medical subject headings
- Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung function testsDiagnostic test
baby-body plethysmography
Nasal brushingDiagnostic test
Epithelial sample collecting for in vitro study
| Study group | Role | What they receive |
|---|---|---|
| PTSE | Experimental | Prenatal tobacco smoke exposed newborns. Lung function test Nasal brushing Receives: Diagnostic Test: lung function tests; Diagnostic Test: Nasal brushing |
| control | Experimental | Prenatal tobacco smoke non exposed newborns Lung function test Nasal brushing Receives: Diagnostic Test: lung function tests; Diagnostic Test: Nasal brushing |
What is being measured
The primary outcome is the main question the study is designed to answer.
α7-nAChR functionnality
calcium influx mesurements on epithelial fragments by monitoring changes in Fluo-4 fluorescence intensity.
Fluo-4 is a fluorescent dye which fluorescence is modified by its linkage to Calcium. Its fluorescence changes measurements shows calcium cellular flows.
Measured: day 3
CFTR functionality
chlorid influx study on epithelial fragmentsby monitoring changes in spq fluorescence intensity.
sqp is a fluorescent dye which fluorescence is modified by its linkage to Chlore. Its fluorescence changes measurements shows chlore cellular flows.
Measured: day 3
Secondary outcomes (2)
Lung function test
baby-body plethysmography that study ventilation in asleep infants (measurement of tidal volumes, respiratory frequency, airway resistances, respiratory system compliance, maximal expiratory flows)
Measured: between ages 2 and 6 week
ciliary frequency mesurement
On epithelial fragments. By using vidéo microscopy and select several delimited zone where ciliary frequency is measured. Then a mean freqeuncy is calculated
Measured: day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start10 Nov 2017
- Primary completion9 Feb 2018
- Study completion9 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pierre MAURAN, MD PHD, Study director, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047967
- Sponsor's protocol ID
- C15-60
- Status last verified
- Feb 2025
- First submitted
- 26 Jan 2017
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effets du Tabagisme in Utero Sur la fonctionnalité de l'épithelium Respiratoire et Sur la Fonction Ventilatoire du Nouveau-né.
- ClinicalTrials.gov ID
- NCT03047967
- Acronym / sponsor ID
- C15-60
- Conditions
- Pregnancy Related, Tobacco Smoking, Lung Smokers, Newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 9 Feb 2018 (actual)
- Study completion
- 9 Feb 2019 (actual)
- First posted
- 9 Feb 2017 (estimated)
- 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.
Despite public campaigns to prevent cigarette smoking, it's about 20% of women who keep on smoking during pregnancy, exposing their fetus to prenatal tobacco adverse effects. Although environnemental tobacco smoke exposure effects are well known, consequences of prenatal tobacco smoke exposure (PTSE) need better caracterization. Previous animal study from our group have shown, in prenatal nicotine exposed mouse pups, alterations in tracheal epithelial structure similar to those observed in KO α7-nAChR mouse pups. These findings support the hypothesis that α7-nAChR are involved in the process of deleterious effects of tobacco smoking on respiratory epithelium development. The purpose of the present clinical study is to compare PTSE neonates with controls according to lung function and respiratory epithelial functionality. At the age of 3 days, small respiratory epithelium fragments will be obtained from gentle nasal brushing performed under antalgic premedication according to the method we previously published. Epithelium samples will be used for in vitro studies of α7-nAChR and CFTR functionality. Between the ages of 2 and 6 weeks, lung function testing will be performed, by means of baby-body plethysmography.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTSE | Experimental | Diagnostic Test: lung function tests, Diagnostic Test: Nasal brushingPrenatal tobacco smoke exposed newborns. Lung function test Nasal brushing |
| control | Experimental | Diagnostic Test: lung function tests, Diagnostic Test: Nasal brushingPrenatal tobacco smoke non exposed newborns Lung function test Nasal brushing |
Who may qualify
- Ages
- 2 to 6 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- inborn full-term neonate
- social security affiliation
- informed consent form signed by parents
Key exclusion criteria (12 listed)
- prematurity < 35GW
- gemellary pregnancy
- Birth weight < 2200 g
- neonatal respiratory distress syndrome (nasal oxygenotherapy > 24 hours, invasive or noninvasive ventilation)
- neonatal malformation with conséquences on lung function
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 |
|---|---|---|
| lung function testsbaby-body plethysmography | Diagnostic test | PTSE, control |
| Nasal brushingEpithelial sample collecting for in vitro study | Diagnostic test | PTSE, control |
Primary outcome
α7-nAChR functionnality
Time frame: day 3
calcium influx mesurements on epithelial fragments by monitoring changes in Fluo-4 fluorescence intensity. Fluo-4 is a fluorescent dye which fluorescence is modified by its linkage to Calcium. Its fluorescence changes measurements shows calcium cellular flows.
CFTR functionality
Time frame: day 3
chlorid influx study on epithelial fragmentsby monitoring changes in spq fluorescence intensity. sqp is a fluorescent dye which fluorescence is modified by its linkage to Chlore. Its fluorescence changes measurements shows chlore cellular flows.
2 secondary outcomes
Lung function test
Time frame: between ages 2 and 6 week
ciliary frequency mesurement
Time frame: day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
Pierre MAURAN, MD PHD study director
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lung function tests and Nasal brushing in people with Pregnancy Related and Tobacco Smoking, run by Institut National de la Santé Et de la Recherche Médicale, France 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 3 inclusion and 12 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: finished, as of the sponsor's last update on 20 Feb 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
α7-nAChR functionnality (time frame: day 3). The study lists 2 primary outcomes in all. 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 20 Feb 2025.