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

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ClinicalTrials.gov Identifier: NCT03047967
Recruitment Status : Completed
First Posted : February 9, 2017
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

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.

Condition or disease Intervention/treatment Phase
Pregnancy Related Tobacco Smoking Lung Smokers Newborn Diagnostic Test: lung function tests Diagnostic Test: Nasal brushing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effets du Tabagisme in Utero Sur la fonctionnalité de l'épithelium Respiratoire et Sur la Fonction Ventilatoire du Nouveau-né.
Actual Study Start Date : November 10, 2017
Actual Primary Completion Date : February 9, 2018
Actual Study Completion Date : February 9, 2019

Arm Intervention/treatment
Experimental: PTSE
Prenatal tobacco smoke exposed newborns. Lung function test Nasal brushing
Diagnostic Test: lung function tests
baby-body plethysmography

Diagnostic Test: Nasal brushing
Epithelial sample collecting for in vitro study

Experimental: control
Prenatal tobacco smoke non exposed newborns Lung function test Nasal brushing
Diagnostic Test: lung function tests
baby-body plethysmography

Diagnostic Test: Nasal brushing
Epithelial sample collecting for in vitro study




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   up to 6 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03047967


Locations
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France
Inserm
Paris, France, 75000
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Study Director: Pierre MAURAN, MD PHD Institut National de la Santé Et de la Recherche Médicale, France

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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT03047967     History of Changes
Other Study ID Numbers: C15-60
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No