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OpenTrials
Completed

NCT Number: NCT03047967

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

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.

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Key information

Age range

2 day–6 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inserm

Paris, 75000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lung Function tests

Diagnostic Test

baby-body plethysmography

Nasal brushing

Diagnostic Test

Epithelial sample collecting for in vitro study

Primary outcomes

  1. α7-nAChR functionnality

    Time frame: 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.

  2. CFTR functionality

    Time frame: 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 outcomes

  1. Lung function test

    Time frame: 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)

  2. ciliary frequency mesurement

    Time frame: 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

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Feb 9, 2017
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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