Effectiveness of Synagis (Palivizumab) Immunoprophylaxis in Preterm Infants With High Risk of Severe Respiratory Syncytial Virus (RSV) Infection

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Overview

Published data by the Organización panamericana de la Salud shows that Peru's mortality rate from acute respiratory infections (ARI) in infants less than one year of life is second only to Haiti (14,150/100,000). Government data reports shows a marked increase of RSV infections in Peru. "Instituto Nacional de Salud" (Peru's National Institute of Health) reports between January 1st to February 26th 2006, 62% of their positive samples corresponded to RSV. Epidemiological data from Lima-Peru, demonstrates that there is no specific season for RSV infection although some data suggest an increase in RSV activity during cold months (May to September; INS data). Clinical studies show that giving five doses of Synagis (palivizumab) resulted in serum concentrations \> 30 ug/mL for \>20 weeks. The aim of this post-marketing observational study is to determine the RSV hospitalization rate in high-risk infants who received Synagis (palivizumab) through the Social Security Hospitals in the context of routine clinical practice.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Respiratory Syncytial Virus Infection

Interventions

Synagis (palivizumab), monoclonal antibody for passive immunoprophylaxis against severe RSV disease administered according to usual clinical practice.

Eligibility

Sex: ALLMax age: 6 Months

Medical Language ↔ Plain English

Inclusion Criteria: * Receiving Synagis (palivizumab) immunoprophylaxis during respiratory syncytial virus season, according to the usual clinical practice: * 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: * Major congenital malformation aside from congenital heart disease * 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.

Locations (4)

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

Outcomes

Primary Outcomes

Number of Hospital Admissions by Respiratory Syncytial Virus Infection

The number of participants hospitalized for respiratory syncytial virus infection from the first dose of study drug up to the visit coinciding with the first birthday of the participant. An indirect immunofluorescence test (a laboratory technique used to detect the presence of viruses) was used to determine if hospitalized participants had respiratory syncytial virus infection.

Time frame: First year of life (up to 12 months)

Secondary Outcomes

Number of Hospital Admission Days (All Causes)

The mean (average) number days participants were hospitalized.

Time frame: Hospital admission to hospital discharge

Number of Intensive Care Unit Days During the Hospital Admissions by Respiratory Syncytial Virus Infection

The number of days spent in a hospital intensive care unit (ICU) are summarized for those participants requiring that type of care. An indirect immunofluorescence test (a laboratory technique used to detect the presence of viruses) was used to determine if hospitalized participants had respiratory syncytial virus infection.

Time frame: Hospital admission to hospital discharge

Number of Ventilation Support Days (Supplemental Oxygen and Mechanical Ventilation) During the Hospital Admission

The mean (average) number of days participants required supplemental oxygen during any hospital stay and the mean number of days participants required mechanical ventilation while in the intensive care unit.

Time frame: Hospital admission to hospital discharge

Number of Serious Adverse Events

The number participants experiencing a serious adverse event. For additional information see the Reported Adverse Events section.

Time frame: Enrollment until 100 days after the last Synagis (palivizumab) dose