Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 11:58 PM
Study NCT ID:
NCT00524394
Status:
TERMINATED
Last Update Posted:
2015-12-14
First Post:
2007-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Characteristics of Cord Blood Immunologic Parameters of Infants <32 Weeks Gestation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D004194', 'term': 'Disease'}], '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': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'james.r.murphy@uth.tmc.edu', 'phone': '713-500-5714', 'title': 'James Murphy, PhD', 'organization': 'University of Texas Health Science Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Early termination leading to small numbers of subjects analyzed'}}, 'adverseEventsModule': {'timeFrame': 'From begining to the end of the study period.', 'eventGroups': [{'id': 'EG000', 'title': 'Infants0-3 Days of Life >1500g or >32 Weeks GA', 'description': 'Infants born at 32 weeks of gestacional age or \\>1500 mg at 0-3 days of life .', 'otherNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Immunological Homeostasis', 'timeFrame': '0 to 30 days of life.', 'description': 'Describe changes in immunological homeostasis that indicate the "normal" function vs. presence of sepsis in newborn infants of various gestational ages', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Cytokines', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INFANTS 0 to 3 Days of Life (DOL) >1500 G OR >32 WEEKS GA', 'description': 'INFANTS 0 to 3 days of life born with \\>1500 gm OR \\>32 WEEKS gestational age'}], 'timeFrame': 'O TO 30 DAYS OF LIFE', 'description': 'IL2 IL6 IL8 IL13 MIP1B MCP1 IL1B IL4 IL5 IL7 IL10 IL12P70 Measure of Cytokines presence and level .', 'reportingStatus': 'POSTED', 'populationDescription': 'zero participant analyzed'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Infants 0 to 3 Days of Life >1500 g or >32 Weeks GA', 'description': 'Infants born at \\>32 weeks of gestagional age or \\> 1500gm between 0 to 3 Days of Life'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment using NICU ADMISSION LIST.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'INFANTS', 'description': 'INFANTS 0 to 3 days of life \\>1500 G OR \\>32 WEEKS GA'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum only'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'recruitment not possible', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-05', 'studyFirstSubmitDate': '2007-08-30', 'resultsFirstSubmitDate': '2013-07-17', 'studyFirstSubmitQcDate': '2007-08-31', 'lastUpdatePostDateStruct': {'date': '2015-12-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-05', 'studyFirstPostDateStruct': {'date': '2007-09-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immunological Homeostasis', 'timeFrame': '0 to 30 days of life.', 'description': 'Describe changes in immunological homeostasis that indicate the "normal" function vs. presence of sepsis in newborn infants of various gestational ages'}, {'measure': 'Cytokines', 'timeFrame': 'O TO 30 DAYS OF LIFE', 'description': 'IL2 IL6 IL8 IL13 MIP1B MCP1 IL1B IL4 IL5 IL7 IL10 IL12P70 Measure of Cytokines presence and level .'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['VLBW', 'sepsis', 'diagnosis', 'suspected sepsis'], 'conditions': ['Premature Birth', 'Sepsis']}, 'descriptionModule': {'briefSummary': "Infants in the NICU are at high risk for morbidity and mortality from infections of any onset. Diagnosis of these infections is imperfect at best. Patterns of inflammatory and regulatory proteins (cytokines \\& chemokines, in addition to antigen detection on antibody secreting cells (ASC's)may provide a more accurate and rapid approach to diagnosis of infections in these high-risk patients.", 'detailedDescription': "Sampling methods/Data collection\n\nSamples: Serum (1-2ml) from enrolled infants will be collected from cord blood (T0). Serial samples (0.5-1ml) will be collected at 3 other times: T1= 4-7 days, T2=10-14 days, T3= 20-30 days. These can be drawn at initiation of any sepsis work-up, or prior to any transfusion of PRBC's or when any blood ≥0.5ml will be wasted. These collections are intended to analyze the immunologic milieu in infants at various stages of natal and post-natal immune adaptation:\n\n1. baseline levels from a relatively privileged environment (cord blood T0)\n2. peak of immunogenic response after prenatal exposure (T1)\n3. plateau of immunogenic response after perinatal exposure (T2)\n4. relative state of equilibrium with surrounding flora (T3)\n\nData collection:\n\nBaseline statistics at enrollment: Birth weight, obstetrical assessment of gestational age, mode of delivery, presence of labor, presence of IAI, ROM, intrapartum antibiotics type and length, With each sampling, data will be gathered via chart review on each infant. We will also gather data at 60 DOL, discharge, or death on any infant enrolled.\n\nMeasurements:\n\nExperimental laboratory:\n\nCytokines- Each sample will have plasma analyzed by Luminex (Biorad) to determine profiles of cytokines: IL-2, IL-6, IL-8, IL-13, MIP1b, MCP1, IL-1b, IL-4, IL-5, IL-7, IL-10, IL-12p70, IL-17, GMCSF, IFN-gamma, and TNF-alpha. Standard curves for each cytokine measurement were run to determine upper and lower limits of detection.\n\nASC- will be quantified by enzyme-linked immunospot assay (ELISPOT) for specific isotypes IgA, IgM, and IgG. They will also be linked to 3 particular immunogenic agents: GBS, Candida, and CoNS.\n\nClinical laboratory:\n\nTotal WBC and band ratio will be run in the routine course of care for these infants. This is not an additional sample.\n\nserious bacterial infections other than sepsis (meningitis, UTI)\n\n* Course of Study- 0-30 days of life for sampling. 0-60 days of life for data collection.\n* Enrollment- consecutive admissions of NICU under the following criteria\n\nInclusion:\n\nAdmitted to NICU at MHCH\n\n* 1500gm or ≤ 32 wk GA Birth to \\<31 days of life at time of enrollment\n\nExclusion:\n\nKnown or suspected immunodeficiency (including maternal HIV or other known congenital infection) Known major congenital anomaly\n\n* Recruitment Will include each eligible infant by the primary investigator or co-investigators. Assuming an incidence of LOS of \\~25% and EOS of \\~1-3%, a power of 80%, we should enroll 50 infants. This coincides with prior studies evaluating ASC's response in neonates, and those evaluating cytokines in cord blood and post-natally.\n* Known Risks There will be no additional blood draws. There will be collection of a greater volume of blood (additional 0.5ml-1.0ml depending on size of infant) during clinical indications for blood draws. No clinical decisions will be made based on the data obtained."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Premature infants', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Infants born at Children's Memorial Hermann Hospital with cord blood available \\< 1500gm or \\< 32 weeks gestation by OB estimate\n\nExclusion Criteria:\n\n* Outborn infants transferred to CMHH without cord blood available\n* Parents to not consent\n* \\> 1500gm or \\> 32 weeks gestation by OB estimate"}, 'identificationModule': {'nctId': 'NCT00524394', 'acronym': 'AOS', 'briefTitle': 'Characteristics of Cord Blood Immunologic Parameters of Infants <32 Weeks Gestation', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Characteristics of Cord Blood Immunologic Parameters of Infants < 32 Weeks Gestation', 'orgStudyIdInfo': {'id': 'HSC-MS-07-0021'}}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Children's Memorial Hermann Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'James R Murphy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas at Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}