Incidence of Severe Respiratory Syncytial Virus Infections in Preterm Brazilian Children
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Respiratory Syncytial Viruses Respiratory Tract Infection |
Procedure: Samples collection for viral diagnosis Procedure: Lung Function Analysis |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Incidence of Severe Respiratory Syncytial Virus Infections in Preterm Brazilian Children - BREVI (Brazilian Respiratory Virus in Premature Infants) Study |
- To determine the incidence of severe RSV LRTI requiring hospitalization among infants born <35 weeks gestational age for one year. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
- To evaluate the risk and protective factors for severe RSV LRTI in preterm Brazilian infants. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
- To describe the seasonality of RSV infection in three cities in Brazil. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
- To compare the incidence of wheezing episodes by 12 months after maternity hospital discharge among children with and without RSV LRTI. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
- 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. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
white cells and nasopharyngal aspirate
| Enrollment: | 310 |
| Study Start Date: | January 2008 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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. 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).
|
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.
Eligibility| Ages Eligible for Study: | up to 35 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
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)
Contacts and Locations| Brazil | |
| Site Ref # / Investigator 6185 | |
| Curitiba, PR, Brazil, 80060-900 | |
| Site Ref # / Investigator 6189 | |
| Ribeirao Preto, SP, Brazil, 14049-900 | |
| Study Chair: | Lino Rodrigues, MD | Abbott Laboratórios do Brasil Ltda. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00585481 History of Changes |
| Other Study ID Numbers: | A07-006 |
| Study First Received: | December 22, 2007 |
| Last Updated: | December 15, 2011 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Keywords provided by Abbott:
|
Epidemiological Study Incidence of severe Respiratory Syncytial Virus Preterm Brazilian children |
Additional relevant MeSH terms:
|
Respiratory Syncytial Virus Infections Respiratory Tract Infections Virus Diseases Pneumovirus Infections Paramyxoviridae Infections |
Mononegavirales Infections RNA Virus Infections Infection Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013