Non-Invasive Pressure Monitor for Neonates & Infants at Risk of Developing Hydrocephalus
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Efficacy of modified smart soft contact lens evaluation of external intracranial pressure before and after shunt surgery (Aim 2)
研究概览
简要总结
The goal of this clinical trial is to test a modified smart soft contact lens in neonates and infants at risk of developing hydrocephalus. The main questions it aims to answer are:
- Can the device distinguish between intracranial pressure variations in neonates and infants diagnosed with hydrocephalus and those without
- Can the device compare pressure dynamics between pre- and post-operative periods in neonates and infants who undergo surgical treatments Participants will undergo standard of care evaluations for hydrocephalus (anterior fontanelle assessment and head circumference measurement) and wear the device during standard of care evaluation; pre- and post- ventricular reservoir taps, as applicable; and/or pre- and post-operatively, as applicable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 0 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being monitored for hydrocephalus, or healthy controls
排除标准
- •Known hypersensitivity to materials used in the contact lens and/or adhesive
- •Open/closed wounds at/near the anterior fontanelle
- •Anterior fontanelle is closed
- •Other conditions deemed relevant by the medical team
结局指标
主要结局
Efficacy of modified smart soft contact lens evaluation of external intracranial pressure before and after shunt surgery (Aim 2)
时间窗: Continuously measured for up to 4 hours prior to shunt surgery and continuously measured for up to 4 hours after shunt surgery
ICP readings from the device will be compared to standard of care assessments and measurements in patients undergoing shunt insertion
Efficacy of modified smart soft contact lens evaluation of external intracranial pressure at single time point (Aim 1)
时间窗: Day 1, continuously measured for up to 4 hours
ICP readings from the device will be compared to standard of care assessments and measurements in healthy control patients and hydrocephalus patients
Efficacy of modified smart soft contact lens evaluation of external intracranial pressure during hydrocephalus evaluation (Aim 3)
时间窗: Continuously measured for up to 4 hours while EVD/ICP monitoring is in place
ICP readings from the device will be compared to standard of care assessments and measurements in patients with an EVD/ICP monitor
Efficacy of modified smart soft contact lens evaluation of external intracranial pressure before and after reservoir taps (Aim 4)
时间窗: Continuously measured for up to 4 hours prior to reservoir tapping and continuously measured for up to 4 hours after reservoir tapping
ICP readings from the device will be compared to standard of care assessments and measurements in patients with a reservoir, pre- and post-tap
次要结局
未报告次要终点
研究者
Jignesh Tailor
Assistant Professor of Neurological Surgery
Indiana University