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IN UTERO SMOKING AND PREMATURE CELLULAR SENESCENCE

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ClinicalTrials.gov Identifier: NCT01865435
Recruitment Status : Completed
First Posted : May 30, 2013
Last Update Posted : October 1, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:

Actually, there is an increasing number of arguments for a premature origin of chronic adult's diseases, as the chronic obstructive pulmonary disease (COPD). Several factors interacting with the foetal or postnatal lung growth are associated with early and long-lasting respiratory functional changes susceptible to contribute very significantly to the arisen of a COPD in the adulthood. It is possible that these situations reflect phenomena of premature cellular senescence, recently involved in the physiopathology of the COPD. An in utero exposition to cigarette smoking is one of these situations, because it is known to induce, not only functional respiratory changes, but also multiple diseases in the child which could testify of cellular ageing phenomena.

Our project aims to demonstrate that in utero smoking is associated with markers of premature cellular senescence in newborn children

The study will be driven in human newborn child's, with comparison of the length of the telomeres in circulating lymphocytes (umbilical blood is collected), according to the exposure in in utero smoking and also according to the degree of hypotrophy. This study will be a pilot study completed by an animal experimental study.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Genetic: cord blood sample Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: IN UTERO SMOKING AND PREMATURE CELLULAR SENESCENCE
Study Start Date : March 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: new borns Genetic: cord blood sample



Primary Outcome Measures :
  1. cord blood samples [ Time Frame: 12months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 27 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Born weight upper or equal to the 10th percentile and absence of smoking declared by the mother
  • Born weight lower than the 10th percentile and absence of smoking declared by the mother
  • Born weight upper or equal to the 10th percentile and smoking declared by the mother of at least 5 cigarettes a day
  • Born weight lower than the 10th percentile and smoking declared by the mother of at least 5 cigarettes a day

Exclusion Criteria:

  • Gestationnel age 37 LIMITED COMPANIES
  • Low(Weak) declaratory(declarative) maternal smoking (1 in 4 cigarettes a day)
  • Pathologies associated by the newborn child (deformations, foetal suffering, infection maternofœtale, respiratory distress syndrome)

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): NCT01865435


Locations
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France
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: LOIC MONDOLONI Assistance Publique Hopitaux De Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01865435     History of Changes
Other Study ID Numbers: 2012-A01655-38
2012-52 ( Other Identifier: AP HM )
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: October 1, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases