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

NCT ID: NCT03047967

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-10

Study Completion Date

2019-02-09

Brief Summary

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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.

Detailed Description

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Conditions

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Pregnancy Related Tobacco Smoking Lung Smokers Newborn

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PTSE

Prenatal tobacco smoke exposed newborns. Lung function test Nasal brushing

Group Type EXPERIMENTAL

lung function tests

Intervention Type DIAGNOSTIC_TEST

baby-body plethysmography

Nasal brushing

Intervention Type DIAGNOSTIC_TEST

Epithelial sample collecting for in vitro study

control

Prenatal tobacco smoke non exposed newborns Lung function test Nasal brushing

Group Type EXPERIMENTAL

lung function tests

Intervention Type DIAGNOSTIC_TEST

baby-body plethysmography

Nasal brushing

Intervention Type DIAGNOSTIC_TEST

Epithelial sample collecting for in vitro study

Interventions

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lung function tests

baby-body plethysmography

Intervention Type DIAGNOSTIC_TEST

Nasal brushing

Epithelial sample collecting for in vitro study

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

2 Days

Maximum Eligible Age

6 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre MAURAN, MD PHD

Role: STUDY_DIRECTOR

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

Locations

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Inserm

Paris, , France

Site Status

Countries

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France

Other Identifiers

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C15-60

Identifier Type: -

Identifier Source: org_study_id

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