Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT01167660
Status:
UNKNOWN
Last Update Posted:
2013-02-12
First Post:
2010-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non Invasive Measurement of Coagulation in Term and Preterm Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-02-11', 'studyFirstSubmitDate': '2010-07-05', 'studyFirstSubmitQcDate': '2010-07-21', 'lastUpdatePostDateStruct': {'date': '2013-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reliability of the non-invasive ThM device.', 'timeFrame': 'From birth up to 1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Coagulation tests', 'Neonates', 'Non invasive'], 'conditions': ['Blood Coagulation Tests']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the reliability of a new non-invasive device to assess the blood coagulation status among term and preterm babies.', 'detailedDescription': "Coagulation abnormalities among neonates aren't common - but can be life threatening. Testing the coagulation system in small babies involves drawing significant amounts of blood (especially in premature babies). Non-invasive testing can help assess and treat term and preterm neonates at risk. Recently, a non-invasive device to assess the blood coagulation status was developed - The Thrombo-Monitor (ThM). The objective of this study is to assess the reliability of this new non-invasive device among term and preterm babies by comparing the result of the ThM reading to coagulation analysis from blood."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Term and preterm babies born in Meir Medical Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newborn babies - term and preterm\n* Written parental informed consent\n\nExclusion Criteria:\n\n* Congenital anomalies / chromosomal abnormalities'}, 'identificationModule': {'nctId': 'NCT01167660', 'briefTitle': 'Non Invasive Measurement of Coagulation in Term and Preterm Neonates', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'Non Invasive Measurement of Coagulation in Term and Preterm Neonates', 'orgStudyIdInfo': {'id': 'Pag-ThM2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy newborn babies', 'description': 'Healthy newborn babies immediately after birth.', 'interventionNames': ['Device: The Thrombo-Monitor (ThM)']}, {'label': 'Sick newborn babies', 'description': 'Sick newborn babies whose medical condition indicates performing coagulation tests.', 'interventionNames': ['Device: The Thrombo-Monitor (ThM)']}], 'interventions': [{'name': 'The Thrombo-Monitor (ThM)', 'type': 'DEVICE', 'description': 'Non-invasive measurement of coagulation status and comparison to standard blood coagulation tests. In healthy neonates - immediately after birth, before the administration of vitamin K. Coagulation tests will be done on an umbilical cord blood sample. In sick neonates, coagulation studies will be done according to the medical condition.', 'armGroupLabels': ['Healthy newborn babies', 'Sick newborn babies']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kfar Saba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Ita Litmanovitz Litmanovitz, MD', 'role': 'CONTACT', 'email': 'litmani@clalit.org.il', 'phone': '09-7471554'}, {'name': 'Ita Litmanovits, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}], 'centralContacts': [{'name': 'Ita Litmanovitz, MD', 'role': 'CONTACT', 'email': 'litmani@clalit.org.il', 'phone': '+972-9-7471554'}, {'name': 'Gisela Laura Sirota, MD', 'role': 'CONTACT', 'email': 'gisela.sirota@clalit.org.il', 'phone': '+972-9-7471554'}], 'overallOfficials': [{'name': 'Ita Litmanovitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meir Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}