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临床试验/NCT03047967
NCT03047967已完成不适用

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

Institut National de la Santé Et de la Recherche Médicale, France2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2017年11月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1
试验地点
2
主要终点
α7-nAChR functionnality

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
2 Days 至 6 Days(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

PTSE

Experimental

Prenatal tobacco smoke exposed newborns. Lung function test Nasal brushing

干预措施: lung function tests (Diagnostic Test)

PTSE

Experimental

Prenatal tobacco smoke exposed newborns. Lung function test Nasal brushing

干预措施: Nasal brushing (Diagnostic Test)

control

Experimental

Prenatal tobacco smoke non exposed newborns Lung function test Nasal brushing

干预措施: lung function tests (Diagnostic Test)

control

Experimental

Prenatal tobacco smoke non exposed newborns Lung function test Nasal brushing

干预措施: Nasal brushing (Diagnostic Test)

结局指标

主要结局

α7-nAChR functionnality

时间窗: 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.

CFTR functionality

时间窗: 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.

次要结局

  • Lung function test(between ages 2 and 6 week)
  • ciliary frequency mesurement(day 3)

研究者

发起方
Institut National de la Santé Et de la Recherche Médicale, France
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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