Effects of Prenatal Tobacco Smoke Exposure on Lung Function and Respiratory Epithelium Functionality in Newborns

Institut National de la Santé Et de la Recherche Médicale, France

Status: Completed

Conditions: Lung Smokers; Pregnancy Related; Tobacco Smoking; Newborn

Treatments: Diagnostic Test: lung function tests; Diagnostic Test: Nasal brushing

Study type: Interventional

Funder types: Other

Identifiers

NCT03047967

C15-60

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 2 to 6 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

PTSE

Experimental group

Description:

Prenatal tobacco smoke exposed newborns. Lung function test Nasal brushing

Treatment:

Diagnostic Test: Nasal brushing

Diagnostic Test: lung function tests

control

Experimental group

Description:

Prenatal tobacco smoke non exposed newborns Lung function test Nasal brushing

Treatment:

Diagnostic Test: Nasal brushing

Diagnostic Test: lung function tests