Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT03019692
Status:
RECRUITING
Last Update Posted:
2017-01-12
First Post:
2017-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longterm Outcome of Children With Neonatal Intra-Ventricular or Intra-Cranial Hemorrhage
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-11', 'studyFirstSubmitDate': '2017-01-11', 'studyFirstSubmitQcDate': '2017-01-11', 'lastUpdatePostDateStruct': {'date': '2017-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'need for surgery related to neonatal hemorrhage', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'normal schooling according to age', 'timeFrame': '6 years'}, {'measure': 'need for ADL assistance beyond acceptable per age', 'timeFrame': '6 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Neonates Premature']}, 'descriptionModule': {'briefSummary': "Intraventricular hemorrhage (IVH) is the most commonly recognized cerebral lesion on ultrasound in extremely preterm infants. Papile classification is commonly used to grade the severity of IVH. Grade III-IV IVH and other lesions noted on ultrasound including periventricular leukomalacia (pvl) porencephaly, and ventriculomegaly are well Documented to be associated with adverse neurodevelopmental outcomes.\n\nHowever, the true impact of lower-grade IVH on the neurodevelopment of these extreme preterm infants has not been well described.\n\nAlso Neurodevelopmental outcome for neonatal non-traumatic Intra Cranial Hemorrhage (ICH) is not well established.\n\nThe aim of this study is to look retrospectively at babies with neonatal IVH or ICH and follow their radiological, cognitive, motor and functional outcomes.\n\nThe study will focus on postnatal files, and on images performed as part of the child's follow-up during hospitalization and after discharge.", 'detailedDescription': 'The study will be performed as a Retrospective chart review with key words : IVH, ICH of babies discharged from Laniado Hospital Neonatal care service or ICU, or being followed in the pediatric neurosurgical clinic and prematurity/neonatology clinic of the hospital.\n\nAll charts of such children will be included, to review clinical, and radiological available data.\n\nRegistration of Clinical, Radiological data as presented or submitted by the parents on Neurosurgical neonatology and Neurological Followups will be performed by PI or CI and coded in the data anonymously.\n\nFollow up will be performed as clinically indicated without addition of any specific studies due to the research.\n\nThe endpoints of the study:\n\nprimary endpoint:\n\n1. How many children needed surgical intervention related to the hemorrhage (ICH, IVH) secondary endpoints:\n2. Clinical and functional outcome of children - REGARDING normal schooling, need for assistance in ADL in difference from the parallel normal child.\n\ncorrelation between the type of hemorrhage, clinical data related to gestational age and weight at birth, and outcomes will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'minimumAge': '1 Hour', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'newborns or premature babies who suffered intra-cranial or intra-ventricular hemorrhage within the first 3 months after birth or before discharge after delivery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nnewborns or premature babies who suffered intra-cranial or intra-ventricular hemorrhage children who are followed by PI in the neurosurgical clinic in Laniado hospital and suffered from ICH or IVH and were treated elsewhere after birth -\n\nExclusion Criteria:\n\nloss to followup within the first year after birth\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03019692', 'acronym': 'NEONATAL ICH', 'briefTitle': 'Longterm Outcome of Children With Neonatal Intra-Ventricular or Intra-Cranial Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Laniado Hospital'}, 'officialTitle': 'Longterm Outcome of Children With Neonatal Intra-Ventricular or Intra-Cranial Hemorrhage (IVH, ICH)', 'orgStudyIdInfo': {'id': '0148-16-LND-2016121'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'enrolled babies with neonatal intracranial bleed', 'description': 'all babies who suffered from intra cranial or intraventricular bleed during neonatal period'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Netanya', 'state': 'Israel', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Nechama Sharone, MD', 'role': 'CONTACT', 'email': 'nsharon@laniado.org.il', 'phone': '972-544303356'}, {'name': 'Nechama Sharon, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Sharon Nechama, Laniado Hospital', 'geoPoint': {'lat': 32.33291, 'lon': 34.85992}}], 'centralContacts': [{'name': 'LIANA ADANI BENI, MD', 'role': 'CONTACT', 'email': 'DRLIANA.PEDNS@GMAIL.COM', 'phone': '97298609336'}, {'name': 'INA FURMAN', 'role': 'CONTACT', 'email': 'IFURMAN@LANIADO.ORG.IL', 'phone': '97298609127'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laniado Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Liana.Adani', 'investigatorFullName': 'Laniado Hospital', 'investigatorAffiliation': 'Laniado Hospital'}}}}