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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Viruses; Respiratory Tract Infection
• Intervention / Treatment: Procedure: Samples collection for viral diagnosis; Procedure: Lung Function Analysis

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.

• Study Type: Observational
• Enrollment (Actual): 310

Contacts and Locations

Study Locations

• Brazil
  • PR
    • Curitiba, PR, Brazil, 80060-900
      • Site Ref # / Investigator 6185
  • SP
    • Ribeirao Preto, SP, Brazil, 14049-900
      • Site Ref # / Investigator 6189

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 8 months (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• Male and female infants that were born <35 weeks gestational age

• The inclusion must be done during the following period:

  • 24 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the incidence of severe RSV LRTI requiring hospitalization among infants born <35 weeks gestational age for one year.	1 Year

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Abbott
• Collaborators: Statistika Consultoria Ltda
• Investigators: Study Chair: Lino Rodrigues, MD, Abbott Laboratórios do Brasil Ltda.

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: December 22, 2007
• First Submitted That Met QC Criteria: January 2, 2008
• First Posted (ESTIMATE): January 3, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): December 19, 2011
• Last Update Submitted That Met QC Criteria: December 15, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Epidemiological Study; Incidence of severe Respiratory Syncytial Virus; Preterm Brazilian children
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Respiratory Tract Diseases; Disease Attributes; Paramyxoviridae Infections; Mononegavirales Infections; Pneumovirus Infections; Infections; Communicable Diseases; Virus Diseases; Respiratory Tract Infections; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: A07-006