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Incidence of Severe Respiratory Syncytial Virus Infections in Preterm Brazilian Children

NCT ID: NCT00585481

Last Updated: 2011-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

310 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Respiratory Syncytial Viruses Respiratory Tract Infection

Keywords

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Epidemiological Study Incidence of severe Respiratory Syncytial Virus Preterm Brazilian children

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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1

All subjects will perform samples collection for RSV analysis. Subject's enrolled in Porto Alegre's site will perform lung function tests.

Samples collection for viral diagnosis

Intervention Type 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.

Lung Function Analysis

Intervention Type 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).

Interventions

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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.

Intervention Type 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).

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Maximum Eligible Age

35 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Statistika Consultoria Ltda

INDUSTRY

Sponsor Role collaborator

Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lino Rodrigues, MD

Role: STUDY_CHAIR

Abbott Laboratórios do Brasil Ltda.

Locations

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Site Ref # / Investigator 6185

Curitiba, Paraná, Brazil

Site Status

Site Ref # / Investigator 6189

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

Related Links

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http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=23151&CFID

Related Info

Other Identifiers

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A07-006

Identifier Type: -

Identifier Source: org_study_id