Effects of Prenatal Tobacco Smoke Exposure on Lung Function and Respiratory Epithelium Functionality in Newborns
NCT ID: NCT03047967
Last Updated: 2025-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1 participants
INTERVENTIONAL
2017-11-10
2019-02-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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PTSE
Prenatal tobacco smoke exposed newborns. Lung function test Nasal brushing
lung function tests
baby-body plethysmography
Nasal brushing
Epithelial sample collecting for in vitro study
control
Prenatal tobacco smoke non exposed newborns Lung function test Nasal brushing
lung function tests
baby-body plethysmography
Nasal brushing
Epithelial sample collecting for in vitro study
Interventions
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lung function tests
baby-body plethysmography
Nasal brushing
Epithelial sample collecting for in vitro study
Eligibility Criteria
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Inclusion Criteria
* social security affiliation
* informed consent form signed by parents
Exclusion Criteria
* 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
* 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
2 Days
6 Days
ALL
Yes
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Responsible Party
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Principal Investigators
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Pierre MAURAN, MD PHD
Role: STUDY_DIRECTOR
Institut National de la Santé Et de la Recherche Médicale, France
Locations
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Inserm
Paris, , France
Countries
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Other Identifiers
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C15-60
Identifier Type: -
Identifier Source: org_study_id
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