Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-31 @ 1:30 AM
Study NCT ID:
NCT01912703
Status:
UNKNOWN
Last Update Posted:
2013-07-31
First Post:
2013-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Long-term Neurodevelopmental Outcome After Intraventricular Hemorrhage (IVH)-Grades I-II in Preterm Infants at Ages 1-7 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-07-30', 'studyFirstSubmitDate': '2013-07-29', 'studyFirstSubmitQcDate': '2013-07-30', 'lastUpdatePostDateStruct': {'date': '2013-07-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'General Neurodevelopmental Assessment', 'timeFrame': 'Seven years', 'description': 'Retrospective study of preterm infants born in the years 2007-2011 and suffered IVH Grades 1-2 who have undergone a general neurodevelopmental assessment in the Institute for Child Development in Hillel Yaffe Medical Center at ages 1-7. This assessment will indicate whether IVH Grades 1-2 has any neurodevelopmental effect on these children.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Premature Infants']}, 'descriptionModule': {'briefSummary': 'It is well-known that preterm delivery can be accompanied by complications. One of these complications is Intraventricular Hemorrhage (IVH). There are four degrees of IVH, according to severity. It is known that IVH Grades 3-4 can cause severe neurodevelopmental outcomes, including cerebral palsy (CP), hemiplegia, lower motor and cognitive skills and social difficulties. It is not known whether IVH Grades I-II have any of these effects and the aim of this study is to determine whether they do have any neurodevelopmental outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Preterm infants born in 2007-2011 at the Hillel Yaffe Medical Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All preterm infants born at 35 weeks or less\n* Underwent at least 1 brain ultrasound\n* Diagnosed with IVH Grades 1-2\n* Had no other severe illness in NICU\n* Had neurodevelopmental follow-up\n\nExclusion Criteria:\n\n* All others'}, 'identificationModule': {'nctId': 'NCT01912703', 'briefTitle': 'The Long-term Neurodevelopmental Outcome After Intraventricular Hemorrhage (IVH)-Grades I-II in Preterm Infants at Ages 1-7 Years', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'orgStudyIdInfo': {'id': 'HYMC-297-13'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Preterm infants with IVH Grades I-II', 'description': 'Preterm infants (post-menstrual age 24-35 weeks) who were diagnosed with IVH Grades 1-2 in the neonatal intensive care unit (NICU).', 'interventionNames': ['Other: Telephone interview']}, {'label': 'Control Group', 'description': 'Preterm infants (post-menstrual age 24-35 weeks) who had no imaging evidence of IVH in the neonatal intensive care unit (NICU).', 'interventionNames': ['Other: Telephone interview']}], 'interventions': [{'name': 'Telephone interview', 'type': 'OTHER', 'description': 'Subjects with incomplete data will be asked to complete a telephone interview', 'armGroupLabels': ['Control Group', 'Preterm infants with IVH Grades I-II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'facility': 'Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Roei Abramovitch, MD', 'role': 'CONTACT', 'email': 'roeiabra@gmail.com', 'phone': '972-50-3205548'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}