Follow up at School-age of Children Participating in the Nitric Oxide Ventilatory Approach (NOVA) Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Examine school-readiness at school-age in premature infants treated with iNO or placebo in the first week of life
研究概览
简要总结
Our previous data demonstrated that premature infants treated with inhaled nitric oxide at birth had improved neurodevelopmental outcomes at two years corrected age. We now wish to determine whether this benefit continues through school age.
详细描述
Two questionnaires (truncated versions of previously validated surveys), one for parent and another for teacher, for which written consent was previously obtained are being sent to parents. The teacher questionnaires will be delivered via parents. A clinic visit will accompany age appropriate neurodevelopmental examination, administration of the Functional Independence Measure for Children (WeeFIM) survey, and hearing and visual screening exams (if appropriate).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children who participated in NOVA study and are of school age
排除标准
- •Children who participated in NOVA study but deceased post discharge
研究组 & 干预措施
Inhaled nitric oxide
干预措施: Inhaled nitric oxide (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Examine school-readiness at school-age in premature infants treated with iNO or placebo in the first week of life
时间窗: 4-7 years of age (between 2005-2006)
次要结局
- Examine health status at early school-age(4-7 years of age (between 2005-2006))