An interventional study of lung function tests and Nasal brushing in Pregnancy Related, Tobacco Smoking and Lung Smokers, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Completed at 1 site in France. Open to participants aged 2 Days to 6 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-20.
Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Not applicable, Interventional, and Diagnostic
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.
Institut National de la Santé Et de la Recherche Médicale, France is the lead sponsor of 375 studies on the registry; 82 are open to participants now.
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Prenatal tobacco smoke exposed newborns. Lung function test Nasal brushing
Diagnostic Test: lung function tests · Diagnostic Test: Nasal brushing
Prenatal tobacco smoke non exposed newborns Lung function test Nasal brushing
Diagnostic Test: lung function tests · Diagnostic Test: Nasal brushing
baby-body plethysmography
Epithelial sample collecting for in vitro study
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.
Time frame: 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.
Time frame: day 3
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)
Time frame: 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
Time frame: day 3
Plan to share: Undecided
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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Institut National de la Santé Et de la Recherche Médicale, France