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

Completed

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

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Hospital Admissions by Respiratory Syncytial Virus Infection	First year of life (up to 12 months)	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.

Secondary Outcome Measures

Name	Time	Method
Number of Hospital Admission Days (All Causes)	Hospital admission to hospital discharge	The mean (average) number days participants were hospitalized.
Number of Intensive Care Unit Days During the Hospital Admissions by Respiratory Syncytial Virus Infection	Hospital admission to hospital discharge	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.
Number of Ventilation Support Days (Supplemental Oxygen and Mechanical Ventilation) During the Hospital Admission	Hospital admission to hospital discharge	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.
Number of Serious Adverse Events	Enrollment until 100 days after the last Synagis (palivizumab) dose	The number participants experiencing a serious adverse event. For additional information see the Reported Adverse Events section.

Locations (4): Site Reference ID/Investigator# 27834
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Arequipa, Peru
Site Reference ID/Investigator# 27836
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Lima, Peru
Site Reference ID/Investigator# 6059
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Callao, Peru
Site Reference ID/Investigator# 27835
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Lima, Peru