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Incidence of Severe Respiratory Syncytial Virus Infections in Preterm Brazilian Children

NCT00585481 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 310

Last updated 2011-12-19

No results posted yet for this study

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.

Conditions

  • Respiratory Syncytial Viruses
  • Respiratory Tract Infection

Interventions

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).

Sponsors & Collaborators

  • Statistika Consultoria Ltda

    collaborator INDUSTRY

  • Abbott

    lead INDUSTRY

Principal Investigators

  • Lino Rodrigues, MD · Abbott Laboratórios do Brasil Ltda.

Eligibility

Max Age
35 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Brazil

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00585481 on ClinicalTrials.gov