A Randomized Crossover Study to Evaluate Differences Between the Bayley-II and the Bayley-III in Very Preterm Infants at 2 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- The primary outcome is the mean difference between BSID-II Mental Development Index (MDI) and Bayley-III Cognitive Score.
研究概览
简要总结
The objective of this randomized study is to test the hypothesis that scores on the Bayley Scales of Infant Development-III (Bayley-III) are higher than scores on the Bayley Scales of Infant Development-II (BSID-II) in the same group of infants who were born very preterm.
详细描述
The objective of this randomized crossover study is to test the hypothesis that scores on the Bayley Scales of Infant Development-III are higher than scores on the Bayley Scales of Infant Development-II in the same group of infants who were born very preterm. First, however, the investigators must demonstrate that significant "learning" does not occur when the tests are administered 4-8 weeks apart. The investigators hypothesize that scores on the Bayley-III will be higher than scores on the BSID-II, irrespective of the order in which the tests are administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Months 至 22 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Birth weight <2000 grams and <32 weeks
- •Corrected age of 18-22 months.
排除标准
- •English is not the primary language in the child's home.
- •Parent is unable to give informed consent for research participation.
- •Parent is unable to commit to returning for follow-up testing in 4-8 weeks.
- •Infant has severe medical illness or disability expected to impact his/her ability to participate in testing (ex: blindness, deafness, severe cerebral palsy, autism, tracheostomy).
- •No exclusion for economic status, gender, race or ethnicity.
- •Participation in a RCT that restricts timing and administration of developmental testing.
结局指标
主要结局
The primary outcome is the mean difference between BSID-II Mental Development Index (MDI) and Bayley-III Cognitive Score.
时间窗: 18-22 months
次要结局
- The mean difference in scores between time point one and time point two (a measure of learning or training).(18-22 months)
- Mean difference between BSID-II Physical Development Index and Bayley-III Composite Motor Score.(18-22 months)
- Proportion of infants classified as having "developmental delay" (MDI <70 on BSID-II or either Language or Cognitive Score <70 on the Bayley-III).(18-22 months)