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Sponsors and Collaborators: |
Abbott Statistika Consultoria Ltda |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00585481 |
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 |
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Respiratory Syncytial Viruses Respiratory Tract Infection |
Procedure: Samples collection for viral diagnosis |
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 |
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 |
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1
All subjects will perform samples collection for RSV analysis.
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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 |
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.
Ages Eligible for Study: | up to 35 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Study Director: | Jader Baima, MD, PhD | Abbott |
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 |
EPIDEMIOLOGICAL STUDY INCIDENCE OF SEVERE RESPIRATORY SYNCYTIAL VIRUS PRETERM BRAZILIAN CHILDREN |
Virus Diseases Antibodies Paramyxoviridae Infections Respiratory Tract Diseases |
Respiratory Tract Infections Respiratory Syncytial Virus Infections Immunoglobulins |
Communicable Diseases RNA Virus Infections Pneumovirus Infections Infection Mononegavirales Infections |