Incidence of Severe Respiratory Syncytial Virus Infections in Preterm Brazilian Children

NCT00585481 | Completed

• 1 other identifier: A07-006
• Study Type: observational
• Target: 310
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Respiratory Syncytial Viruses; Respiratory Tract Infection

Keywords

Epidemiological Study; Incidence of severe Respiratory Syncytial Virus; Preterm Brazilian children

Outcome Measures

Primary Outcomes (1)

• To determine the incidence of severe RSV LRTI requiring hospitalization among infants born <35 weeks gestational age for one year.

  1 Year

Secondary Outcomes (4)

• To evaluate the risk and protective factors for severe RSV LRTI in preterm Brazilian infants.

  1 Year

• To describe the seasonality of RSV infection in three cities in Brazil.

  1 Year

• To compare the incidence of wheezing episodes by 12 months after maternity hospital discharge among children with and without RSV LRTI.

  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.

  1 Year

Study Arms (1)

1

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

Interventions

Samples collection for viral diagnosis PROCEDURE

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.

1

Lung Function Analysis PROCEDURE

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).

1

Eligibility Criteria

• Age: Up to 35 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants \< 35 wGA born into or transferred to a participating hospital meeting all of the inclusion criteria and none of the exclusion criteria specified in the protocol will be selected to participate. Subjects will be identified in the NICU or newborn nursery and enrolled in the study 24 hours prior to confirmed hospital discharge or up to 72 hours after maternity hospital discharge date.

You may qualify if:

• Male and female infants that were born \<35 weeks gestational age
• hours prior confirmed maternity hospital discharge date, or
• Up to 72 hours after documented maternity hospital discharge date. In this case, RSV rapid test must be performed and subjects should be enrolled only if the results is negative.
• Less than 6 months of age at screening
• Born into or transferred to a participating hospital
• Able to receive follow-up medical care at the participating site and provide information during the follow-up period
• The legal representative is capable of understanding and complying with parameters as outlined in the protocol and able and willing to participate in this study, by signing the informed consent approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), after all the aspects of the study that might be relevant for his/her decision to participate are explained and all his/her questions and doubts are elucidated, and prior to the initiation of any screening or study-specific procedures.

You may not qualify if:

• Receipt of palivizumab or other immunoglobulin preparation containing RSV specific antibodies (i.e. RSV hyperimmunoglobulin, polyclonal intravenous immunoglobulin, cytomegalovirus hyperimmunoglobulin, varicella-zoster hyperimmunoglobulin)

Sponsors & Collaborators

• Abbott: lead
• Statistika Consultoria Ltda: collaborator

Study Sites (2)

Site Ref # / Investigator 6185

Curitiba, Paraná, 80060-900, Brazil

Location

Site Ref # / Investigator 6189

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

white cells and nasopharyngal aspirate

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Lino Rodrigues, MD

  Abbott Laboratórios do Brasil Ltda.

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2007
• First Posted: January 3, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 19, 2011

Record last verified: 2011-11

Locations

BR (2)