Pregnancy Related, Tobacco Smoking, Lung Smokers, Newborn
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTlung function tests
baby-body plethysmography
DIAGNOSTIC_TESTNasal brushing
Epithelial sample collecting for in vitro study
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Days to 6 Days
Healthy volunteers
Yes
Inclusion criteria
* inborn full-term neonate * social security affiliation * informed consent form signed by parents
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| α7-nAChR functionnality | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung function test | between ages 2 and 6 week | baby-body plethysmography that study ventilation in asleep infants (measurement of tidal volumes, respiratory frequency, airway resistances, respiratory system compliance, maximal expiratory flows) |
| ciliary frequency mesurement | day 3 | On epithelial fragments. By using vidéo microscopy and select several delimited zone where ciliary frequency is measured. Then a mean freqeuncy is calculated |
Countries
France
Outcome results
None listed