Clinical trial NCT01107535: Effectiveness of Synagis (Palivizumab) Immunoprophylaxis in Preterm Infants With High Risk of Severe Respiratory Syncytial Virus (RSV) Infection
Official title: Observational Study of the Effectiveness of Synagis Immunoprophylaxis in Preterm Infants With High Risk of Severe Respiratory Syncytial Virus Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Syncytial Virus Infection
Keywords: Synagis (palivizumab) immunoprophylaxis
Respiratory syncytial virus infection
Preterm infants
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2010-04-21
Enrollment: 82
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pre term neonates who received Synagis (palivizumab) according to the clinical practice. The study is implemented in 4 hospitals of Peru.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Hospital Admissions by Respiratory Syncytial Virus Infection
timeFrame: First year of life (up to 12 months)
Secondary outcomes:
measure: Number of Hospital Admission Days (All Causes)
timeFrame: Hospital admission to hospital discharge
measure: Number of Intensive Care Unit Days During the Hospital Admissions by Respiratory Syncytial Virus Infection
timeFrame: Hospital admission to hospital discharge
measure: Number of Ventilation Support Days (Supplemental Oxygen and Mechanical Ventilation) During the Hospital Admission
timeFrame: Hospital admission to hospital discharge
measure: Number of Serious Adverse Events
timeFrame: Enrollment until 100 days after the last Synagis (palivizumab) dose
Other outcomes:
Locations:
city: Arequipa
country: Peru
facility: Site Reference ID/Investigator# 27834
city: Callao
country: Peru
facility: Site Reference ID/Investigator# 6059
city: Lima
country: Peru
facility: Site Reference ID/Investigator# 27836
city: Lima
country: Peru
facility: Site Reference ID/Investigator# 27835
Study officials:
affiliation: Abbott
name: Oscar Guerra, MD
role: STUDY_DIRECTOR
References: