NCT03066895已完成不适用
Development and Testing of BabyGentleStick™ Vibrated Needle System for Heel Lance- Neonatal Pilot Study
Actuated Medical, Inc.2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年11月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Adverse events
研究概览
简要总结
This is a pilot, randomized, safety and efficacy study of an investigational device (i.e. BabyGentleStick™; BGS, Actuated Medical, Inc). The primary study objectives are to obtain subject feedback, assess device performance; and ascertain potential harm in healthy adult volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Weeks 至 42 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically stable late preterm/term neonates with a gestational age at birth of > 35 weeks gestation at birth
- •Sex: male or female
排除标准
- •Congenital anomalies or conditions at birth impacting central nervous system functioning and autonomic measurements
- •Known risk for bleeding (i.e. Hemophilia, blood clotting or protein disorders)
- •Prolonged labor or delayed birth with evidence of perinatal depression (e.g. Infant Apgar scores below 5)
- •Identified maternal opiate dependency during pregnancy placing the infant at risk for opiate withdrawal, also known as neonatal abstinence syndrome (NAS)
- •Critical illness in the mother preventing the ability to obtain informed consent from parents
结局指标
主要结局
Adverse events
时间窗: Up to 8 days
No device-attributable adverse events.
次要结局
- Pain Response(2 minute intervals, starting at 15 minutes before procedure and continuing until 10 minutes post procedure)
研究者
研究点 (2)
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