Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
Study NCT ID:
NCT01430832
Status:
TERMINATED
Last Update Posted:
2018-07-02
First Post:
2011-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Developmental Outcomes of Extreme Prematurity, 5-15 Years Postpartum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Recruitment Status', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-09-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-28', 'studyFirstSubmitDate': '2011-09-07', 'studyFirstSubmitQcDate': '2011-09-07', 'lastUpdatePostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Not relevant', 'timeFrame': 'Not relevant'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PTSD', 'Preterm', 'Premature', 'VLBW'], 'conditions': ['Preterm Infants', 'Post Traumatic Stress Disorder', 'Emotional Stress', 'Infant, Very Low Birth Weight']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to assess the emotional well being of mothers to preterm infants with ELBW 5-15 years after the birth. Post-traumatic symptoms and parental stress levels will be taken into consideration. In addition, the correlation between the infant's development and the mother's emotional state will be analyzed.", 'detailedDescription': "Medical records of the children will be used for information in four categories: prenatal, birth, development,and demographic information. Parents will be contacted and interviewed regarding the child's development. In addition, they will complete the following questionnaires: PPQ-II Perinatal PTSD Questionnaire- modified, PTGI -The Posttraumatic Growth Inventory,Parental Stress Index- Short Form- PSI-SF, and Life Events questionnaire."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants are children born at Sheba Medical center between the years 1995-2006.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm Infant\n* Very low birth weight or extremely low birth weight\n\nExclusion Criteria:\n\n* Missing information regarding birth week and weight'}, 'identificationModule': {'nctId': 'NCT01430832', 'briefTitle': 'Developmental Outcomes of Extreme Prematurity, 5-15 Years Postpartum', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'The Long-Term Developmental Outcomes of Extreme Prematurity: Correlations With Maternal Post-Traumatic Symptoms, Parental Stress and Post-Traumatic Growth, 5-15 Years Postpartum', 'orgStudyIdInfo': {'id': 'SHEBA-10-8121-LG-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal Development', 'description': "The infant's development level will be assessed using a phone interview with parents"}, {'label': 'Abnormal Development', 'description': "The infant's level of development will be assessed using a phone interview with parents"}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'overallOfficials': [{'name': 'Lidia Gabis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}, {'name': 'Gabi Zerach, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ariel University'}, {'name': 'Shefer Shahar, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sheba Medical Center'}, {'name': 'Adi Elsing, BA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sheba Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}