Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2026-01-10 @ 4:16 AM
Study NCT ID:
NCT00983606
Status:
COMPLETED
Last Update Posted:
2012-11-14
First Post:
2009-09-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study to Assess Respiratory Syncytial Virus (RSV) Respiratory Events Among Premature Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum (frozen)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-13', 'studyFirstSubmitDate': '2009-09-23', 'studyFirstSubmitQcDate': '2009-09-23', 'lastUpdatePostDateStruct': {'date': '2012-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint is the incidence rate of outpatient RSV LRI during the RSV season, with RSV LRI determined by real time RT-PCR', 'timeFrame': 'Sep. 2009-Feb. 2010; Sep. 2010-Feb. 2011'}], 'secondaryOutcomes': [{'measure': 'Rate of RSV-associated emergency department (ED) visits during the RSV season', 'timeFrame': '2009-2010; 2010- 2011'}, {'measure': 'Rate of RSV-associated hospitalization during the RSV season', 'timeFrame': '2009-2010; 2010-2011'}, {'measure': 'Rate of risk factors for RSV-associated outpatient LRI, hospitalization, and ED visits', 'timeFrame': '2009-2010; 2010-2011'}, {'measure': 'Rate of risk factors for RSV infection', 'timeFrame': '2009-2010; 2010-2011'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '27898687', 'type': 'DERIVED', 'citation': 'Simoes EA, Anderson EJ, Wu X, Ambrose CS. Effects of Chronologic Age and Young Child Exposure on Respiratory Syncytial Virus Disease among US Preterm Infants Born at 32 to 35 Weeks Gestation. PLoS One. 2016 Nov 29;11(11):e0166226. doi: 10.1371/journal.pone.0166226. eCollection 2016.'}, {'pmid': '24622396', 'type': 'DERIVED', 'citation': 'Ambrose CS, Anderson EJ, Simoes EA, Wu X, Elhefni H, Park CL, Sifakis F, Groothuis JR. Respiratory syncytial virus disease in preterm infants in the U.S. born at 32-35 weeks gestation not receiving immunoprophylaxis. Pediatr Infect Dis J. 2014 Jun;33(6):576-82. doi: 10.1097/INF.0000000000000219.'}]}, 'descriptionModule': {'briefSummary': "The primary objective is to assess the burden of respiratory disease in outpatient settings among 32 to 35 weeks' gestational age (wGA) infants in the USA who did not receive RSV prophylaxis during the infants' first RSV season.", 'detailedDescription': "The primary objective is to determine the burden of RSV disease in outpatient settings among 32 to 35 wGA infants in the USA who did not receive RSV prophylaxis, as measured by rate of RSV-associated outpatient lower respiratory tract illness (LRI) during the infants' first RSV season."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Premature babies at birth - (32-35 WGA)', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Premature at birth (from 32 weeks and 0 days to 35 weeks and 6 days GA)\n* Age 6 months or less at the time of screening, and born in May 2009 through January 2010 for Season 1, or May 2010 through February 2011 for Season 2\n* Written informed consent and any locally required authorization (eg, HIPAA), obtained from the subject's parent/or guardian prior to performing any protocol-related procedures.\n\nExclusion Criteria:\n\n* Receipt of any RSV prophylactic agent: at any time prior to study participation\n* Participation in studies of investigational RSV prophylaxis or RSV therapeutic agents\n* Presence of bronchopulmonary dysplasia,hemodynamically significant congenital heart disease, congenital neuromuscular or congenital airway defects\n* Any condition that, in the opinion of the investigator, would limit life expectancy to less than 6 months"}, 'identificationModule': {'nctId': 'NCT00983606', 'briefTitle': 'An Observational Study to Assess Respiratory Syncytial Virus (RSV) Respiratory Events Among Premature Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'An Observational Prospective Study to Assess Respiratory Syncytial Virus (RSV) Respiratory Events Among Premature Infants (32 to 35 Week Gestational Age) - Outcomes and Risk Tracking Study (The Report Study)', 'orgStudyIdInfo': {'id': 'MI-MA213'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': '32 to 35 WGA Infants less than six months of age by RSV season peak.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35235', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36305', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '36037', 'city': 'Greenville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 31.8296, 'lon': -86.61775}}, {'zip': '36604', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '36066', 'city': 'Prattville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.46402, 'lon': -86.4597}}, {'zip': '35768', 'city': 'Scottsboro', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.67231, 'lon': -86.03415}}, {'zip': '36701', 'city': 'Selma', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.40736, 'lon': -87.0211}}, {'zip': '35150', 'city': 'Sylacauga', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.17317, 'lon': -86.25164}}, {'zip': '35401', 'city': 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