A One-Year Observational Study of Palivizumab in Infants at Risk for Respiratory Syncytial Virus Infection in Latin America
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 464
- 试验地点
- 24
- 主要终点
- Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Children excluded from receiving palivizumab as per local guidelines
结局指标
主要结局
Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection
时间窗: Baseline
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).
Distribution of Comorbidities in Study Participants
时间窗: Baseline
The percentage of participants with each and combinations of the three comorbidities for which palivizumab is indicated.
次要结局
- Characterization of Hospitalization Episodes Due to Lower Respiratory Tract Infection and RSV(12 months)
- Risk Factors for Hospitalization(Baseline and 12 months)
- Compliance to Prescribed Palivizumab(12 months)
- Mean Number of Doses of Palivizumab Administered(12 months)
- Number of Participants With Hospitalizations for Lower Respiratory Tract Infection and RSV(12 months)