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
Verified date | November 2011 |
Source | Abbott |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: National Health Surveillance Agency |
Study type | Observational |
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.
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) |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Brazil | Site Ref # / Investigator 6185 | Curitiba | PR |
Brazil | Site Ref # / Investigator 6189 | Ribeirao Preto | SP |
Lead Sponsor | Collaborator |
---|---|
Abbott | Statistika Consultoria Ltda |
Brazil,
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 |
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