NL-OMON51712尚未招募不适用
The COllaborative Neonatal NEtwork for the first CPAM Trial, the CONNECT - CONNECT trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 11（—）
入选标准
- •- Lesion detected during routine prenatal ultrasound screening
- •- Delivery at term: gestational age >=37 weeks
- •- Birthweight > -2SD or >P10
- •- Asymptomatic at birth defined as no prolonged respiratory distress or oxygen
- •support (< 24 hours)
- •- Asymptomatic up to the moment of inclusion
- •- Confirmation of CPAM on postnatal chest CT-scan at 3-9 months of age,
- •according to structured report form
- •- Unilateral lesion occupying no more than one lung lobe as assessed on chest
- •CT-scan at 3-9 months of age
排除标准
- •- Bilateral lesion
- •- Development of symptoms before randomization, considered by treating
- •physician as caused by CPAM with reasonable certainty
- •- Complicated pregnancy defined as (pre-)eclampsia, pregnancy diabetes in
- •mother, foetal hydrops or severe polyhydramnios on prenatal ultrasound
- •- Syndrome associated anomalies on genetic analysis confirmed by genetic expert
- •- Major associated malformations. Anomalies include cardiac malformations
- •requiring surgical correction or follow-up by a paediatric cardiologist,
- •congenital malformations requiring major surgical intervention, and anomalies
- •that affect normal lung growth and development.
- •- Suspicion of malignancy on chest CT scan evaluation at the age of 3-9 months
- •- Participation in another randomised controlled trial
研究者
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