NCT00585481

Incidence of Severe Respiratory Syncytial Virus Infections in Preterm Brazilian Children

Incidence of Severe Respiratory Syncytial Virus Infections in Preterm Brazilian Children - BREVI (Brazilian Respiratory Virus in Premature Infants) Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 310 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 35 Weeks
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to determine the incidence of severe RSV LRTI requiring hospitalization among infants born \< 35 weeks gestational age for one year of follow-up.

Detailed description

This is an epidemiologic study of the incidence of severe RSV LRTI among Brazilian children born \<35WGA. The study will enroll competitively 350 subjects from 3 sites in Brazil. Preterm children will be identified after birth and up to 72 hours after hospital discharge and followed for one year after the enrollment. Subjects will be seen monthly for the first 6 months and bimonthly until one year of follow-up. At each visit, a medical and social history will be updated and a physical examination will be performed. Legal representative will notify study personnel in the event of a respiratory illness or hospital admission at which time the subject will be seen by an investigator. Children with LRTI diagnosed by physical examination will have viral diagnostic tests performed. Subjects with a LRTI not requiring hospitalization will be followed by telephone weekly until illness resolution. Hospitalized children with a LRTI will be followed daily while hospitalized and followed by telephone until illness resolution. All medical interventions and outcomes will be recorded.

Conditions

• Respiratory Syncytial Viruses
• Respiratory Tract Infection

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2008-01-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2008-01-03
• Last updated: 2011-12-19

Locations

2 sites across 1 country: Brazil