Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 1:19 AM
Study NCT ID:
NCT00333333
Status:
COMPLETED
Last Update Posted:
2008-06-13
First Post:
2006-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mechanism of Thrombocytopenia in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Cord blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-06-12', 'studyFirstSubmitDate': '2006-06-02', 'studyFirstSubmitQcDate': '2006-06-02', 'lastUpdatePostDateStruct': {'date': '2008-06-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the mechanism of thrombocytopenia in small for gestational age infants versus infants with maternal preeclampsia exposure', 'timeFrame': 'Each infant will only be enrolled during the time of birth until cord blood is collected.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Thrombocytopenia', 'Small for Gestational Age (SGA)', 'Preeclampsia'], 'conditions': ['Thrombocytopenia', 'Small for Gestational Age (SGA)', 'Preeclampsia']}, 'descriptionModule': {'briefSummary': 'This research project is studying the causes for low platelet levels in preterm infants. Platelets are a component of blood that helps with clotting. The purpose of this study is to determine whether the cause for low platelet levels is the same in infants who are born to mothers with preeclampsia and infants who are small for gestational age.', 'detailedDescription': 'Thrombocytopenia is a common entity in infants who are born to mothers with preeclampsia and in infants who are small for gestational age. There have been several theories to the mechanism underlying thrombocytopenia in these groups of patients. One mechanism suggests that thrombocytopenia in these populations may be secondary to underproduction of platelets. Other studies have implied that low platelet levels may be due to endothelial activation causing platelet consumption. This study is being performed to help determine the mechanism causing thrombocytopenia in infants born to mothers with preeclampsia and comparing it to the mechanism of thrombocytopenia in infants who are small for gestational age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In utero infants who are small for gestational age or who are exposed to maternal pre-eclampsia', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants who are less than 34 weeks gestation\n* Infants born to mothers with preeclampsia\n* Infants who are born small for gestational age whose mother did not have preeclampsia\n\nExclusion Criteria:\n\n* Infants who are greater than 34 weeks gestation\n* Infants with known congenital anomalies or known congenital infections'}, 'identificationModule': {'nctId': 'NCT00333333', 'briefTitle': 'Mechanism of Thrombocytopenia in Infants', 'organization': {'class': 'OTHER', 'fullName': 'Christiana Care Health Services'}, 'officialTitle': 'Mechanism of Thrombocytopenia in Small for Gestational Age Infants Versus Infants With Maternal Preeclampsia Exposure', 'orgStudyIdInfo': {'id': 'CCC# 26075'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SGA infants', 'description': 'Infants who are thought to be small for gestational age (SGA)', 'interventionNames': ['Procedure: Cord blood']}, {'label': 'Pre-eclampsia exposed', 'description': 'Infants who are born to mothers who had pre-eclampsia', 'interventionNames': ['Procedure: Cord blood']}], 'interventions': [{'name': 'Cord blood', 'type': 'PROCEDURE', 'description': 'Cord blood will be obtained at the time of delivery.', 'armGroupLabels': ['Pre-eclampsia exposed', 'SGA infants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Care Health Systems', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}], 'overallOfficials': [{'name': 'Kelly Zook, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Christiana Care Health Systems; Thomas Jefferson University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christiana Care Health Services', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Cardeza Foundation for Hematologic Research', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Kelly Zook, MD', 'oldOrganization': 'Christiana Hospital'}}}}