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

Pregnancy Related Clinical Trial

Official title:

Effets du Tabagisme in Utero Sur la fonctionnalité de l'épithelium Respiratoire et Sur la Fonction Ventilatoire du Nouveau-né.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03047967
• Other study ID #: C15-60
• Status: Completed
• Phase: N/A
• Start date: November 10, 2017
• Est. completion date: February 9, 2019

Study information

• Verified date: April 2019
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: February 9, 2019
• Est. primary completion date: February 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 6 Days

Eligibility

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

Related Conditions & MeSH terms

• Lung Smokers
• Newborn
• Pregnancy Related
• Tobacco Smoking

Intervention

Diagnostic Test:
• lung function tests
baby-body plethysmography
• Nasal brushing
Epithelial sample collecting for in vitro study

Locations

Country	Name	City	State
France	Inserm	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a7-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.	day 3
Primary	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.	day 3
Secondary	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)	between ages 2 and 6 week
Secondary	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	day 3