Incidence of Severe Respiratory Syncytial Virus Infections in Preterm Brazilian Children - Full Text View

Sponsors and Collaborators:	Abbott Statistika Consultoria Ltda
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00585481

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

MedlinePlus related topics: Respiratory Syncytial Virus Infections

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Open Label, Single Group Assignment
Official Title:	Incidence of Severe Respiratory Syncytial Virus Infections in Preterm Brazilian Children - BREVI (Brazilian Respiratory Virus in Premature Infants) Study

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 ]

Estimated Enrollment:	350
Study Start Date:	January 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 All subjects will perform samples collection for RSV analysis.	Procedure: Samples collection for viral diagnosis At enrollment 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

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 PRIOR TO 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 WEEKLY 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

Criteria

Inclusion Criteria:

Male and female infants that were born <35 weeks gestational age
The inclusion must be done at the same day of maternity hospital discharge
Less than 6 months of age at the time of hospital discharge
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 must voluntarily sign and date the Informed Consent Form, in the format approved by the EC (Ethics Committee), after the nature of the study is explained. The Informed Consent Form must be signed before any study procedure is performed.

Exclusion Criteria:

> 35 weeks of gestational age
Discharged into community prior to enrollment
RSV infection during primary hospitalization (hospital-acquired RSV)
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

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

Contacts

Contact: SUELY KUMAGAI INQUE, Pharm D	(55 11) 5536-7008	suely.kumagai@abbott.com
Contact: Paulo Edwardo Muniz Covizzi, Pharm D	(55 11) 5536-7231	paulo.covizzi@abbott.com

Locations

Brazil, PR
Hospital de Clínicas - Federal University of Paraná	Recruiting
Curitiba, PR, Brazil
Contact: Nelson Augusto R Filho, Physician (55 41) 3360-1800 ext 6216 nelson.rosario@ufpr.br
Principal Investigator: Nelson Augusto R Filho, Physician
Brazil, RS
Hospital São Lucas - Catholic University of Rio Grande do Sul	Recruiting
Porto Alegre, RS, Brazil
Contact: Renato T. Stein, Physician (55 51) 3384-5104 rstein@pucrs.br
Principal Investigator: Renato T. Stein, Physician
Brazil, SP
Hospital das Clínicas University of São Paulo	Recruiting
Ribeirao Preto, SP, Brazil
Contact: Otavio Augusto L Cintra, Physician (55 16) 3602-2925 oacintra@uol.br
Principal Investigator: Otavio Augusto L Cintra, Physician

Sponsors and Collaborators

Abbott

Statistika Consultoria Ltda

Investigators

Study Director:

Jader Baima, MD, PhD

Abbott

More Information

Responsible Party:	Abbott ( Jader Baima )
Study ID Numbers:	A07-006
Study First Received:	December 22, 2007
Last Updated:	July 14, 2008
ClinicalTrials.gov Identifier:	NCT00585481
Health Authority:	Brazil: National Health Surveillance Agency

Keywords provided by Abbott:

EPIDEMIOLOGICAL STUDY
INCIDENCE OF SEVERE RESPIRATORY SYNCYTIAL VIRUS
PRETERM BRAZILIAN CHILDREN

Study placed in the following topic categories:

Virus Diseases
Antibodies
Paramyxoviridae Infections
Respiratory Tract Diseases

Respiratory Tract Infections
Respiratory Syncytial Virus Infections
Immunoglobulins

Additional relevant MeSH terms:

Communicable Diseases
RNA Virus Infections
Pneumovirus Infections
Infection
Mononegavirales Infections

ClinicalTrials.gov processed this record on January 16, 2009