Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-02-17 @ 6:25 PM
Study NCT ID:
NCT02060994
Status:
COMPLETED
Last Update Posted:
2014-05-02
First Post:
2014-02-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Respiratory Morbidity Among Children Who Were Born by Elective Cesarean Section After 37-38 Weeks vs. 39 Weeks and More
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-01', 'studyFirstSubmitDate': '2014-02-08', 'studyFirstSubmitQcDate': '2014-02-11', 'lastUpdatePostDateStruct': {'date': '2014-05-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'There are respiratory complications.', 'timeFrame': 'Age 4-8 years', 'description': 'Respiratory complications are defined as any of: asthma, inhalation therapy, systemic steroids therapy, consultation by a pulmonologist'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Respiratory Complications']}, 'referencesModule': {'references': [{'pmid': '22758608', 'type': 'BACKGROUND', 'citation': 'Nir V, Nadir E, Feldman M. Late better than early elective term Cesarean section. Acta Paediatr. 2012 Oct;101(10):1054-7. doi: 10.1111/j.1651-2227.2012.02772.x. Epub 2012 Jul 16.'}]}, 'descriptionModule': {'briefSummary': "Background: It is known that after Cesarean section is correlated with respiratory complication more, if done after 37-38 week of gestation than if done after 39 weeks or more.\n\nGoal: The aim of the current study is to find out if these respiratory complications extend to later life.\n\nMethode: Reviewing the patients' medical file, and collecting data about respiratory complication.", 'detailedDescription': "Background: It is known that after Cesarean section is correlated with respiratory complication more, if done after 37-38 week of gestation than if done after 39 weeks or more. We have already conducted a study about this topic, and published our results.\n\nGoal: The aim of the current study is to find out if these respiratory complications extend to later life.\n\nMethod: Reviewing the patients' medical file, and collecting data about respiratory complication. We will use the same patients we used at the first study. Respiratory complications are defined as diagnosis of asthma, treatment by inhalations or systemic steroids, or consultation by pulmonologist."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children born in 2007-2009 in "Hillel Yaffe" medical center by elective Cesarean section according to a list of IDs we have.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children born in 2007-2009 our medical center by elective Cesarean section according to a list of IDs we have.\n\nExclusion Criteria:\n\n* Children with respiratory congenital defect that was not known at the first week of life.'}, 'identificationModule': {'nctId': 'NCT02060994', 'briefTitle': 'Respiratory Morbidity Among Children Who Were Born by Elective Cesarean Section After 37-38 Weeks vs. 39 Weeks and More', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Respiratory Morbidity Among Children Who Were Born by Elective Cesarean Section After 37-38 Weeks vs. 39 Weeks and More', 'orgStudyIdInfo': {'id': 'HYMC-0088-13-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': '37-38 weeks', 'description': 'Children who were born by elective Cesarean section after 37-38 gestational weeks.\n\nIntervention: No intervention.', 'interventionNames': ['Other: No intervention']}, {'label': '39 week or more', 'description': 'Children who were born by elective Cesarean section after 39 gestational weeks or more Intervention: No intervention.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['37-38 weeks', '39 week or more']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'state': 'North', 'country': 'Israel', 'facility': 'Hillel Yaffe medical center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'overallOfficials': [{'name': 'Erez Nadir, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hillle Yaffe medical center, Hadera, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Neonatologist', 'investigatorFullName': 'Erez Nadir, MD', 'investigatorAffiliation': 'Hillel Yaffe Medical Center'}}}}