Follow-Up at 6 Years of a Cohort of Children Born Very Prematurely With Respiratory and Neurodevelopmental Impact of Early Treatment With Inhaled Nitric Oxide
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Pulmonary Function testing
研究概览
简要总结
Utilization of nitric oxide (NO) therapy has been related to a trend towards short term improvement in very premature infants. A two year follow-up of children treated soon after birth with NO in the neonatal period, suggests that a significant improvement in neurodevelopmental outcome might occur. This study aims to evaluate follow-up at 6 years, in respiratory and neurodevelopmental outcome, of children born very prematurely, some of them having been treated with nitric oxide in the neonatal period.
详细描述
Utilization of nitric oxide therapy in the neonatal period has been related to a trend towards short term improvements in respiratory and neurological outcome at 28 days postnatal age or 36 weeks postconceptional age. A two year follow-up in children treated soon after birth with NO in the neonatal period, suggests that a significant improvement in neurodevelopmental outcome might occur. No long term evaluation on respiratory outcome has yet been done. This study aims to evaluate respiratory and neurodevelopmental outcome at 6 years of age in children born very prematurely, some of them having had Nitric Oxide as a rescue treatment for respiratory distress syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization in the neonatal period. Blinding maintained at the time of the follow-up study
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All infants included at birth in a randomized controlled trial using early nitric oxide therapy
排除标准
- •Parental refusal
研究组 & 干预措施
Study group
Hypoxemic Respiratory Failure treated by Nitric Oxide;
干预措施: Nitric Oxide (Drug)
Control
Hypoxemic Respiratory Failure control (Placebo);
干预措施: Nitric Oxide (Drug)
结局指标
主要结局
Pulmonary Function testing
时间窗: at 7 years postnatal age
次要结局
- Neurodevelopmental and Cognitive outcomes(at 7 years of age)
研究者
Jean Michel Hascoet
Professor - Head of Division
Maternite Regionale Universitaire