NCT05776238已完成不适用
Lateral Position for Premature Babies Undergone Sedation During Magnetic Resonance Imaging: an Observational Study
Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2023年2月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Peripheral oxygen desaturation
研究概览
简要总结
The goal of this observational study is to evaluate safety of sedation in lateral position in premature babies undergone MRI. The main question it aims to answer are:
- number of apneas during sedation
- Maintenance of eupnea during deep sedation
详细描述
Premature babies will be sedated in lateral position during Magnetic Resonance Imaging. During procedure we provide a close control about eupnea maintenance (SaO2 and EtCO2) in order to verify the safety of laying.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 50 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •< 40 weeks Post Conceptional Age (PCA)
排除标准
- •> 50 weeks PCA
- •previous treatment with hypothermia for neonatal asphyxia
- •patients who received invasive positive pressure ventilation within the previous 48 h
- •preexisting cardiac arrhythmias
- •presence or suspicion of oncological pathology
- •neuromuscular or metabolic diseases
- •previous brain or abdominal surgery
- •presence of epicranial venous accesses
- •upper respiratory tract infections
- •refusal of informed consent by parents or inability to express it
结局指标
主要结局
Peripheral oxygen desaturation
时间窗: Through study completion, an average of 7 month
Number of episodes of peripheral oxygen desaturation \< 90% during deep sedation
Apnea
时间窗: Through study completion, an average of 7 month
Number of episodes of apnea \> 20 sec during deep sedation
次要结局
- Post-operative temperature control(Through study completion, an average of 7 month)
- Subjective evaluation of imaging quality(Through study completion, an average of 7 month)
- Objective evaluation of imaging quality(Through study completion, an average of 7 month)
- Time for full enteral feeding(Through study completion, an average of 7 month)
研究者
研究点 (1)
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