Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-02-20 @ 3:33 PM
Study NCT ID:
NCT01865435
Status:
COMPLETED
Last Update Posted:
2015-10-01
First Post:
2013-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IN UTERO SMOKING AND PREMATURE CELLULAR SENESCENCE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-29', 'studyFirstSubmitDate': '2013-05-27', 'studyFirstSubmitQcDate': '2013-05-27', 'lastUpdatePostDateStruct': {'date': '2015-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cord blood samples', 'timeFrame': '12months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': "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.\n\nOur project aims to demonstrate that in utero smoking is associated with markers of premature cellular senescence in newborn children\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '27 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Born weight upper or equal to the 10th percentile and absence of smoking declared by the mother\n* Born weight lower than the 10th percentile and absence of smoking declared by the mother\n* Born weight upper or equal to the 10th percentile and smoking declared by the mother of at least 5 cigarettes a day\n* Born weight lower than the 10th percentile and smoking declared by the mother of at least 5 cigarettes a day\n\nExclusion Criteria:\n\n* Gestationnel age 37 LIMITED COMPANIES\n* Low(Weak) declaratory(declarative) maternal smoking (1 in 4 cigarettes a day)\n* Pathologies associated by the newborn child (deformations, foetal suffering, infection maternofœtale, respiratory distress syndrome)'}, 'identificationModule': {'nctId': 'NCT01865435', 'briefTitle': 'IN UTERO SMOKING AND PREMATURE CELLULAR SENESCENCE', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'IN UTERO SMOKING AND PREMATURE CELLULAR SENESCENCE', 'orgStudyIdInfo': {'id': '2012-A01655-38'}, 'secondaryIdInfos': [{'id': '2012-52', 'type': 'OTHER', 'domain': 'AP HM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'new borns', 'interventionNames': ['Genetic: cord blood sample']}], 'interventions': [{'name': 'cord blood sample', 'type': 'GENETIC', 'armGroupLabels': ['new borns']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13354', 'city': 'Marseille', 'country': 'France', 'facility': 'Assistance Publique Hopitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'LOIC MONDOLONI', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique Hopitaux De Marseille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}