Incidence of Severe Respiratory Syncytial Virus Infections in Preterm Brazilian Children

CompletedOBSERVATIONAL
Enrollment

310

Participants

Timeline

Start Date

January 31, 2008

Primary Completion Date

December 31, 2010

Study Completion Date

December 31, 2010

Conditions
Respiratory Syncytial VirusesRespiratory Tract Infection
Interventions
PROCEDURE

Samples collection for viral diagnosis

"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."

PROCEDURE

Lung Function Analysis

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).

Trial Locations (2)

80060-900

Site Ref # / Investigator 6185, Curitiba

14049-900

Site Ref # / Investigator 6189, Ribeirão Preto

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Statistika Consultoria Ltda

INDUSTRY

lead

Abbott

INDUSTRY