Cohort Study to Evaluate Effects of Prophylactic Treatment for Respiratory Syncytial (RS) Virus Infection in Respiratory Tract During Infancy on Subsequent Atopic Asthma in Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 343
- 主要终点
- The incidence of atopic asthma after three years old in the children who were born as preterm infants and prophylactically treated with palivizumab for RS virus infections during the infancy
研究概览
简要总结
The primary objective of the study is to determine whether the incidence of atopic asthma after three years old may be suppressed in the children who were born as preterm infants and prophylactically treated with palivizumab for respiratory syncytial (RS) virus infections during the infancy.
The secondary objective is to determine whether the incidence of recurrent wheezing after three years old may be suppressed in the children who were born as preterm infants and prophylactically treated with palivizumab for RS virus infections during the infancy.
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
- 3 Years 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born July ~ December 2007 at 33~35 weeks of gestation
- •Infants administered at least 3 doses of palivizumab during the first 6 months of life (Palivizumab treated)
- •Infants not administered any doses of palivizumab during the first 6 months of life (Palivizumab untreated)
排除标准
- •Intrauterine growth retardation (less than -2.5SD)
- •Infants with chronic lung disease (CLD) or other respiratory disease
- •Infants received mechanical ventilation
- •Infants with chronic heart disease (CHD) or congenital anomaly (such as immunodeficiency)
结局指标
主要结局
The incidence of atopic asthma after three years old in the children who were born as preterm infants and prophylactically treated with palivizumab for RS virus infections during the infancy
时间窗: For three years
次要结局
- The incidence of recurrent wheezing after three years old in the children who were born as preterm infants and prophylactically treated with palivizumab for RS virus infections during the infancy(For three years)
研究者
Hiroyuki Mochizuki
Professor, Department of Pediatrics
Tokai University