Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-01-02 @ 3:10 PM
Study NCT ID:
NCT02082535
Status:
UNKNOWN
Last Update Posted:
2014-03-11
First Post:
2014-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S100B as a Marker of Brain Injury of Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D007969', 'term': 'Leukomalacia, Periventricular'}, {'id': 'D002658', 'term': 'Developmental Disabilities'}], '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'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D004678', 'term': 'Encephalomalacia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'lastUpdateSubmitDate': '2014-03-08', 'studyFirstSubmitDate': '2014-02-11', 'studyFirstSubmitQcDate': '2014-03-07', 'lastUpdatePostDateStruct': {'date': '2014-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MRI at term age', 'timeFrame': '2-3 month after recruitment', 'description': 'MRI description according to the protocol suggested by woodward et. al. (2006)'}, {'measure': 'S100b and GFAP', 'timeFrame': '2-3 months after recruitment', 'description': 'The level of S100b in a sample of 0.5 cc saliva will collected every 2 days and GFAP every week from the day of birth to discharge'}], 'secondaryOutcomes': [{'measure': 'Developmental assessment at 18 month', 'timeFrame': '21 month after recruitment', 'description': 'Neurological examination Griffith mental developmental scales (GMD-2) Vineland adaptive behavioral scale (VinelandTM-II) Clinical Adaptive Test/Clinical Linguistic and Auditory Milestone Scale'}, {'measure': 'Developmental assessment at 3 month corrected age', 'timeFrame': '5-6 months after recuitment', 'description': 'Neurological examination General Movements assessment Griffith mental developmental scales (GMD-2) Clinical Adaptive Test/Clinical Linguistic and Auditory Milestone Scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Premature Birth', 'Brain Injuries', 'Leukomalacia Periventricular', 'S100B protein human', 'Glial Fibrillary Acidic Protein', 'Magnetic Resonance Imaging', 'Developmental Disabilities'], 'conditions': ['Premature Birth', 'Brain Injuries', 'Leukomalacia Periventricular', 'Developmental Disabilities']}, 'descriptionModule': {'briefSummary': 'The improvement of treatment of preterm neonates improved their survival, however there is still significant portion of preterm infants (specifically very preterm infants) that suffers from brain insults and as a result developmental deficits. The brain injury is a consequence of hypoxic ischemic events, intracranial hemorrhages, as well as, infections and metabolic crisis. The brain injury is a combination of abnormal myelination, axonal damage and neuronal death. Although there is reduction in focal brain injury, diffuse brain injury is still abundant. Several treatments has been suggested and tested in animal models to prevent the brain insults including glutamate receptor blockers, allopurinol, xenon and different types of stem cells. However, two main obstacles prevent the use of these medication, first the uncertainty of their effect on the developing brain and second the difficulty to time the brain insult. Unlike neonatal asphyxia, when the delivery time and clinical signs are used to time and grade the brain injury, in preterm infants there is no real time tool to indicate severity and timing of brain injury. The disability point out a beneficial therapeutic window is a major obstacle in the acute treatment of brain injury in preterm infants. The aim of this study is to try and delineate such therapeutic window by using brain injury biomarkers.\n\nS100b and GFAP are well recognized biomarkers of brain injury in adults, children and infants. Serial measurements of S100b in saliva (every 2 days) and GFAP in serum (weekly) will be sampled. A database of the clinical status of the infants will be collected, as well as, head ultra sound weekly and head MRI a term age. Development will be assessed by at 18 months. Two hypotheses are stated: One, increase in the levels of S100b and GFAP in their timing will be correlated with the severity of the clinical status, Two the duration of increased level of S100b and GFAP will be associated with abnormal MRI at term findings and abnormal developmental assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Days', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Very early preterm infants born before 30 weeks gestational age', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Preterm delivery before 30 week gestational age\n\nExclusion Criteria:\n\n* Dysmorphic features in initial neurological examination\n* Antenatal brain injury on fetal MRI or ultrasound\n* Brain malformation\n* Maternal drug abuse\n* Maternal use of teratogenic medications'}, 'identificationModule': {'nctId': 'NCT02082535', 'acronym': 'PTS100B', 'briefTitle': 'S100B as a Marker of Brain Injury of Preterm Infants', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'S100B as a Marker of Brain Injury of Preterm Infants', 'orgStudyIdInfo': {'id': 'SHEBA-13-0044-0B-CTIL'}}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Ramat Gan', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Omer Bar-Yosef, Dr.', 'role': 'CONTACT', 'email': 'omerbary@gmail.com', 'phone': '972-52-6667344'}, {'name': 'Omer Bar-Yosef, M.D. PH.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Leah Leibovitch, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tzipi Strauss, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Iris Morag, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Sheba medical center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'centralContacts': [{'name': 'Omer Bar Yosef, M.D. Ph.D.', 'role': 'CONTACT', 'email': 'omer.baryosef@sheba.health.gov.il', 'phone': '972-526667344'}, {'name': 'Leah Leibovitch, M.D.', 'role': 'CONTACT', 'email': 'Leah.Leibovitch@sheba.health.gov.il', 'phone': '972-52-6667325'}], 'overallOfficials': [{'name': 'Omer Bar Yosef, M.D. Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center, Ramat Gan, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Dr. Omer Bar-Yosef', 'investigatorAffiliation': 'Sheba Medical Center'}}}}