Trials / Completed
CompletedNCT03047967
Effects of Prenatal Tobacco Smoke Exposure on Lung Function and Respiratory Epithelium Functionality in Newborns
Effets du Tabagisme in Utero Sur la fonctionnalité de l'épithelium Respiratoire et Sur la Fonction Ventilatoire du Nouveau-né.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France · Other Government
- Sex
- All
- Age
- 2 Days – 6 Days
- Healthy volunteers
- Accepted
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 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
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | lung function tests | baby-body plethysmography |
| DIAGNOSTIC_TEST | Nasal brushing | Epithelial sample collecting for in vitro study |
Timeline
- Start date
- 2017-11-10
- Primary completion
- 2018-02-09
- Completion
- 2019-02-09
- First posted
- 2017-02-09
- Last updated
- 2025-02-20
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03047967. Inclusion in this directory is not an endorsement.