Effectiveness of Synagis (Palivizumab) Immunoprophylaxis in Preterm Infants With High Risk of Severe Respiratory Syncytial Virus (RSV) Infection
NCT ID: NCT01107535
Last Updated: 2012-10-31
Study Results
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View full resultsBasic Information
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COMPLETED
82 participants
OBSERVATIONAL
2007-09-30
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Infants receiving Synagis (palivizumab) immunoprophylaxis
Infants born \<= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
Synagis (palivizumab), monoclonal antibody for passive immunoprophylaxis against severe RSV disease administered according to usual clinical practice.
Synagis (palivizumab) administered according to usual clinical practice. After the enrollment visit, subjects will have monthly visits until they have received the complete Synagis immunization regimen of their hospital, then they will have 2 follow up visits, one of them 30 days after the fifth dose of Synagis and the other visit at one year of age.
Interventions
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Synagis (palivizumab), monoclonal antibody for passive immunoprophylaxis against severe RSV disease administered according to usual clinical practice.
Synagis (palivizumab) administered according to usual clinical practice. After the enrollment visit, subjects will have monthly visits until they have received the complete Synagis immunization regimen of their hospital, then they will have 2 follow up visits, one of them 30 days after the fifth dose of Synagis and the other visit at one year of age.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Infants born \< or = 32 weeks of gestation and are younger than 6 months of age at the beginning of the respiratory syncytial virus season.
* Children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months, until the first year of life.
* Children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment).
Exclusion Criteria
* Chronic pulmonary disease other than bronchopulmonary dysplasia
* Active infections
* Contraindication to Synagis
* Receipt of another immunoglobulin preparation including but not restricted to polyclonal intravenous immunoglobulin, cytomegalovirus hyperimmunoglobulin (Cytogam), or respiratory syncytial virus hyperimmunoglobulin (Respigam).
* Any other condition that according deemed an obstacle for study conduction or representing an unacceptable risk by the participating investigator.
6 Months
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Principal Investigators
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Oscar Guerra, MD
Role: STUDY_DIRECTOR
Abbott
Locations
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Site Reference ID/Investigator# 27834
Arequipa, , Peru
Site Reference ID/Investigator# 6059
Callao, , Peru
Site Reference ID/Investigator# 27836
Lima, , Peru
Site Reference ID/Investigator# 27835
Lima, , Peru
Countries
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Related Links
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Other Identifiers
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PMOS-PERU 07-01
Identifier Type: -
Identifier Source: org_study_id