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

NCT03047967 | Completed

• 1 other identifier: C15-60
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Tobacco Smoking; Lung Smokers; Newborn

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  day 3

Secondary Outcomes (2)

• Lung function test

  between ages 2 and 6 week

• ciliary frequency mesurement

  day 3

Study Arms (2)

PTSE

EXPERIMENTAL

Prenatal tobacco smoke exposed newborns. Lung function test Nasal brushing

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

control

EXPERIMENTAL

Prenatal tobacco smoke non exposed newborns Lung function test Nasal brushing

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

Interventions

lung function tests DIAGNOSTIC_TEST

baby-body plethysmography

PTSE; control

Nasal brushing DIAGNOSTIC_TEST

Epithelial sample collecting for in vitro study

PTSE; control

Eligibility Criteria

• Age: 2 Days - 6 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• inborn full-term neonate
• social security affiliation
• informed consent form signed by parents

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Inserm

Paris, 75000, France

Location

MeSH Terms

Conditions

Tobacco Smoking

Interventions

Respiratory Function Tests

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Pierre MAURAN, MD PHD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: February 9, 2017
• Study Start: November 10, 2017
• Primary Completion: February 9, 2018
• Study Completion: February 9, 2019
• Last Updated: February 20, 2025

Record last verified: 2025-02

Locations

FR (1)