IN UTERO SMOKING AND PREMATURE CELLULAR SENESCENCE

NCT01865435 | Completed

• 2 other identifiers: 2012-A01655-382012-52
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• cord blood samples

  12months

Study Arms (1)

new borns

EXPERIMENTAL

Genetic: cord blood sample

Interventions

cord blood sample GENETIC

new borns

Eligibility Criteria

• Age: Up to 27 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• LOIC MONDOLONI

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2013
• First Posted: May 30, 2013
• Study Start: March 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: October 1, 2015

Record last verified: 2015-09

Locations

FR (1)