Improving the Measurement of Neonatal High Blood Pressure Using the Boppli Device
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility and agreement of Boppli to cuff based measurements
研究概览
简要总结
This study evaluates a new, non-invasive device (Boppli™) that continuously measures blood pressure in newborn infants. The study compares Boppli measurements to standard blood pressure cuff measurements to determine how well the device works and whether it improves identification of high blood pressure in infants in the neonatal intensive care unit (NICU). The study also includes follow-up through 1 year of age to understand longer-term outcomes.
详细描述
High blood pressure in newborn infants (neonatal hypertension) is increasingly recognized but remains difficult to diagnose. There is no single standard definition, and current blood pressure measurements rely on intermittent cuff-based methods. These cuff measurements can be affected by infant movement, agitation, and measurement technique, which may lead to inaccurate classification of blood pressure.
The Boppli™ device is a non-invasive monitoring system that uses a soft band placed on the infant to continuously measure blood pressure using pulse wave signals. Unlike standard cuffs, the device does not inflate and may reduce measurement-related variability.
This is a prospective observational study conducted in infants admitted to the NICU who are less than 5 kg and are at risk for high blood pressure or have clinical concern for elevated blood pressure. The study does not change clinical care, and Boppli measurements will not be used for medical decision-making.
The study has three parts:
Part 1: Feasibility and Comparison of Measurements Infants will wear the Boppli device for up to 72 hours while standard blood pressure cuff measurements are collected as part of routine care. Measurements from the two methods will be compared to evaluate how closely they agree. The study will also assess how easy the device is to use and how well it is tolerated by infants, families, and clinical staff.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Care teams and providers will be aware of the infant's participation, as the Boppli device will be visible. However, as the Boppli measurements will not be used to impact clinical care, the device screen will be covered to minimize distraction. Nursing staff will periodically confirm proper connection and functioning of the device, without removing the screen cover except as necessary. The devices waveform is visible to ensure measurements are taken.
入排标准
- 年龄范围
- 0 Months 至 9 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to the neonatal intensive care unit (NICU)
- •Age 0 to 9 months at time of enrollment
- •Weight less than 5 kg
- •At risk for elevated blood pressure or with clinical concern for hypertension, -including but not limited to:
- •History of acute kidney injury or kidney disease
- •History of extracorporeal membrane oxygenation (ECMO)
- •Parent or legal guardian able to provide informed consent
排除标准
- •Currently receiving extracorporeal membrane oxygenation (ECMO)
- •Currently receiving any form of extracorporeal dialysis (e.g., continuous renal -replacement therapy)
- •Presence of a ventricular assist device
- •Congenital anomalies or clinical conditions that prevent placement of the Boppli™ device
- •For Part 2 only: infants not expected to survive hospitalization
结局指标
主要结局
Feasibility and agreement of Boppli to cuff based measurements
时间窗: 72 hours
Feasibility will be assessed by the proportion of successful blood pressure measurements obtained using the Boppli™ device during the monitoring period and user-reported ease of use. Agreement will be assessed by comparing measurements obtained from the Boppli™ device to those obtained from standard cuff-based measurements using paired measurements.
次要结局
- Diagnostic accuracy of Boppli™ device for identification of elevated blood pressure(72 hours)
- Agreement in classification of elevated blood pressure between Boppli™ and cuff measurements(72 hours)
- User-reported feasibility and acceptability of the Boppli™ device(72-144 hours)
研究者
Cara Slagle
Associate Professor
Indiana University