Incidence of Severe Respiratory Syncytial Virus Infections in Preterm Brazilian Children

This study has been completed.
Sponsor:
Collaborator:
Statistika Consultoria Ltda
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00585481
First received: December 22, 2007
Last updated: December 15, 2011
Last verified: November 2011
  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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.

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).

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
Study Population

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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585481

Locations
Brazil
Site Ref # / Investigator 6185
Curitiba, PR, Brazil, 80060-900
Site Ref # / Investigator 6189
Ribeirao Preto, SP, Brazil, 14049-900
Sponsors and Collaborators
Abbott
Statistika Consultoria Ltda
Investigators
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 August 28, 2014