Incidence of Severe Respiratory Syncytial Virus Infections in Preterm Brazilian Children
|ClinicalTrials.gov Identifier: NCT00585481|
Recruitment Status : Completed
First Posted : January 3, 2008
Last Update Posted : December 19, 2011
|Condition or disease||Intervention/treatment|
|Respiratory Syncytial Viruses Respiratory Tract Infection||Procedure: Samples collection for viral diagnosis Procedure: Lung Function Analysis|
|Study Type :||Observational|
|Actual Enrollment :||310 participants|
|Official Title:||Incidence of Severe Respiratory Syncytial Virus Infections in Preterm Brazilian Children - BREVI (Brazilian Respiratory Virus in Premature Infants) Study|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
All subjects will perform samples collection for RSV analysis. Subject's enrolled in Porto Alegre's site will perform lung function tests.
Procedure: Samples collection for viral diagnosis
Procedure: Lung Function Analysis
At Enrollment and Termination Visits all subjects will have phlebotomy performed for RSV antibody levels (3 mL of blood).
Subjects diagnosed with an LRTI during the study will have a nasopharyngeal lavage (NPL) for viral diagnosis. Phlebotomy for antibody levels will be performed if the current episode represents the first LRTI since study enrollment.
Subjects enrolled in one study site (located in Porto Alegre city) will perform Lung Function Analysis. First measurement will be performed up to Visit 6 and repeated at Termination Visit. Measurements collected in the first analysis will include respiratory compliance and resistance by passive deflation pressure - volume curve, lung volumes by gas dilution method (washout with SF6), lung clearance index with SF6, and maximal flows (rapid thoracic compression from raised volumes).
- To determine the incidence of severe RSV LRTI requiring hospitalization among infants born <35 weeks gestational age for one year. [ Time Frame: 1 Year ]
- To evaluate the risk and protective factors for severe RSV LRTI in preterm Brazilian infants. [ Time Frame: 1 Year ]
- To describe the seasonality of RSV infection in three cities in Brazil. [ Time Frame: 1 Year ]
- To compare the incidence of wheezing episodes by 12 months after maternity hospital discharge among children with and without RSV LRTI. [ Time Frame: 1 Year ]
- To evaluate the difference in lung function among children with and without RSV LRTI within the first year after maternity hospital discharge. Only children enrolled at one participating site will be evaluated with lung function analysis. [ Time Frame: 1 Year ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00585481
|Site Ref # / Investigator 6185|
|Curitiba, PR, Brazil, 80060-900|
|Site Ref # / Investigator 6189|
|Ribeirao Preto, SP, Brazil, 14049-900|
|Study Chair:||Lino Rodrigues, MD||Abbott Laboratórios do Brasil Ltda.|