A One-Year Observation of Palivizumab in Infants at Risk for Respiratory Syncytial Virus Infection in Latin America

AbbVie (prior sponsor, Abbott)464 enrolled

Overview

The study was designed to gather information regarding the use of palivizumab for the prophylaxis for respiratory syncytial virus (RSV) infection in high-risk infants in selected countries within Latin America.

RSV causes significant disease. There is a paucity of data from developing countries even though existing data clearly indicate that RSV accounts for a high proportion of acute respiratory illnesses (ARIs) in children. This is a multi-center study in a cohort of infants at risk for RSV infection in Latin America who have received palivizumab in the usual manner in accordance with the terms of marketing authorization with regard to dose, population and indication. Enrolled participants were followed for one year after their first dose of palivizumab. Epidemiological and clinical data as well as information about compliance, hospitalizations and safety was collected.

Study Type

OBSERVATIONAL

Enrollment

464

Conditions

Respiratory Syncytial Virus Infection

Eligibility

Sex: ALLMax age: 2 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Children with a history of bronchopulmonary dysplasia, infants with a history of prematurity (less than or equal to 35 weeks gestational age), or children with hemodynamically significant congenital heart disease who received the first dose of palivizumab within the 2 weeks prior to the signature of the Informed Consent Form. * Parent or legal guardian of child provides written Informed Consent Exclusion Criteria: * Children excluded from receiving palivizumab as per local guidelines

Locations (24)

Site Reference ID/Investigator# 52185

Buenos Aires, Argentina

Outcomes

Primary Outcomes

Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection

Study participants were characterized at Baseline by history of bronchopulmonary dysplasia, history of prematurity (less than or equal to 35 weeks gestational age), children with hemodynamically significant congenital heart disease (CHD), the presence of cohabitants less than 6 years old, possible exposure to indoor tobacco smoke, day care attendance, asthmatic or atopic mother, smoking during pregnancy, breastfeeding, prenatal assistance (4 or more visits during pregnancy), neonatal hospitalization care, history of neonatal assisted ventilation, and mother education level (completed primary school).

Time frame: Baseline

Distribution of Comorbidities in Study Participants

The percentage of participants with each and combinations of the three comorbidities for which palivizumab is indicated.

Time frame: Baseline

Secondary Outcomes

Number of Participants With Hospitalizations for Lower Respiratory Tract Infection and RSV

The number of participants with hospitalizations due to lower respiratory tract infection (LRTI) and hospitalizations due to lower respiratory tract infection caused by RSV.

Time frame: 12 months

Characterization of Hospitalization Episodes Due to Lower Respiratory Tract Infection and RSV

Time frame: 12 months

Risk Factors for Hospitalization

Variables that could act as risk factors for hospitalization for lower respiratory tract infection were tested in univariate and multivariate Poisson regression models. Baseline characteristics, such as age, gender, birth weight and comorbidities were included as covariates in the Poisson regression model. Variables for multivariate analysis were added applying forward selection. Gestational age and birth weight were included as continuous variables, considering that the higher they were the better they could act as a protection factor for hospitalization due to respiratory infection.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.