Effect of Palivizumab Treatment on Subsequent Recurrent Wheezing in Preterm Infants: Case-control Study by Scientific Committee of Recurrent Wheezing (SCREW)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 444
- 试验地点
- 1
- 主要终点
- Cumulative incidence of recurrent wheezing confirmed by physicians
研究概览
简要总结
The hypothesis of the present study is that the prophylaxis with palivizumab to prevent the severe RS virus infection during the infancy among preterm infants may reduce the risk of subsequent recurrent wheezing in childhood.
The infants born between July 1st and December 31st in 2007 with the gestational age between 33 and 35 weeks were enrolled into the study at the end of RS virus infection season, April 2008. The infants were unintentionally divided into two groups, either palivizumab treated or untreated group at the enrollment, because the timing for palivizumab prophylaxis were already ended.
The study infants will be followed up until the age of 3 with recording the incidence of either parent reported or physician diagnosed recurrent wheezing.
The difference of the incidence of the recurrent wheezing between the groups will be analyzed with Kaplan-Meier method.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Months 至 1 Year（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
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).
- •Infants received less than 3 doses of palivizumab during the first 6 months of life
结局指标
主要结局
Cumulative incidence of recurrent wheezing confirmed by physicians
时间窗: two years
次要结局
- Number of hospital/clinic visits and hospitalizations due to respiratory-related diseases(two years)
- Cumulative incidence of recurrent wheezing confirmed by parents(two years)
- Incidence of atopic asthma evaluated by SCREW according to the results of the questionnaire and hematological examination(two years)
- Cumulative incidence of wheezing confirmed by parents(two years)
- Cumulative incidence of wheezing confirmed by physicians(two years)
研究者
Satoshi Kusuda
Professor of Neonatology
Tokyo Women's Medical University