Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-03-12 @ 3:19 PM
Study NCT ID:
NCT00866567
Status:
COMPLETED
Last Update Posted:
2010-02-03
First Post:
2009-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Defects in Opsonophagocytosis in Premature Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D000071074', 'term': 'Neonatal Sepsis'}, {'id': 'D018805', 'term': 'Sepsis'}], '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': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum cDNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-02', 'studyFirstSubmitDate': '2009-03-19', 'studyFirstSubmitQcDate': '2009-03-19', 'lastUpdatePostDateStruct': {'date': '2010-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Leukocyte phenotype, opsonophagocytic function, and whole blood response to pathogens', 'timeFrame': 'at delivery'}], 'secondaryOutcomes': [{'measure': 'Leukocyte phenotype, opsonophagocytic function during neonatal sepsis', 'timeFrame': '1 week after recruitment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prematurity', 'VLBW', 'sepsis', 'innate immunity'], 'conditions': ['Prematurity', 'Neonatal Sepsis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to characterize innate immune function of premature infants, and identify defects that may be responsible for the development of bacterial sepsis.', 'detailedDescription': 'Sepsis is an important problem in preterm infants and carries a significant morbidity and mortality. It is estimated that 20% of premature infants surviving beyond the first three days of life will have one or more culture-proven bacteremic sepsis. There is increasing epidemiologic and biologic evidence suggesting that preterm newborns are more susceptible to infection than term newborns and adults. Immaturity of the immune system, and, in particular, defects in innate responses to pathogens are of foremost importance in the pathogenesis of neonatal sepsis. The aims of the study are the:\n\n1. Determination of the opsonic capacity of plasma from premature infants, vs. term newborns, and identification possible molecular innate immune defect(s) in preterm plasma.\n2. Characterization of the role of TLR2 and TLR4 responses in phagocytes from premature infants using classical TLRs agonists. Determination of the capacity of plasma from premature infants to sustain TLR pathways, with a particular attention paid to the possible role of soluble MD-2 in plasma from premature infants in TLR-dependent opsonophagocytosis.\n3. Determine prognostic factors for neonatal sepsis. The identification of a quantitative and/or qualitative defect in innate plasma protein(s) in premature newborns has the potential of identifying those infants who are likely to develop a neonatal sepsis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All premature infants delivered at the University Hospitals of Geneva', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Premature or term delivery\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT00866567', 'briefTitle': 'Defects in Opsonophagocytosis in Premature Infants', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Defects in Opsonophagocytosis in Premature Infants as a Factor for the Development of Neonatal Sepsis', 'orgStudyIdInfo': {'id': 'MatPed 08-017'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Premature infants of less than 28 weeks of gestational age'}, {'label': '2', 'description': 'Premature infants of more than 28 weeks and less than 32 weeks of gestational age'}, {'label': '3', 'description': 'Term newborns'}, {'label': '4', 'description': 'Adults'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1211', 'city': 'Geneva', 'state': 'Geneva 14', 'country': 'Switzerland', 'facility': 'University Hospitals of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Jerome PUGIN, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospitals of Geneva'}, {'name': 'Michel BERNER, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospitals of Geneva'}, {'name': 'Pierre TISSIERES, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals of Geneva'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gertrude Von Meissner Foundation', 'class': 'OTHER'}, {'name': 'European Society of Intensive Care Medicine', 'class': 'OTHER'}, {'name': 'Swiss National Fund for Scientific Research', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Pierre TISSIERES, MD; MSc', 'oldOrganization': 'University Hospital, Geneva'}}}}