Incidence of Severe Respiratory Syncytial Virus Infections in Preterm Brazilian Children

Respiratory Tract Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00585481
• Other study ID #: A07-006
• Status: Completed
• Phase: N/A
• First received: December 22, 2007
• Last updated: December 15, 2011
• Start date: January 2008
• Est. completion date: December 2010

Study information

• Verified date: November 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 35 Weeks

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Infection
• Respiratory Syncytial Virus Infections
• Respiratory Syncytial Viruses
• Respiratory Tract Infection
• Respiratory Tract Infections
• Virus Diseases

Intervention

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.
• 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).

Locations

Country	Name	City	State
Brazil	Site Ref # / Investigator 6185	Curitiba	PR
Brazil	Site Ref # / Investigator 6189	Ribeirao Preto	SP

Sponsors (2)

Lead Sponsor	Collaborator
Abbott	Statistika Consultoria Ltda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the incidence of severe RSV LRTI requiring hospitalization among infants born <35 weeks gestational age for one year.		1 Year	No
Secondary	To evaluate the risk and protective factors for severe RSV LRTI in preterm Brazilian infants.		1 Year	No
Secondary	To describe the seasonality of RSV infection in three cities in Brazil.		1 Year	No
Secondary	To compare the incidence of wheezing episodes by 12 months after maternity hospital discharge among children with and without RSV LRTI.		1 Year	No
Secondary	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	No

External Links

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