A Pilot Study to Evaluate Patient Tolerance and Nursing Ease-of-Use of a Novel Hearing Protection Device to Reduce Exposure to Excessive Noise Among Patients Undergoing Neonatal Intensive Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Number of Participants With Skin Erythema After Device Application
研究概览
简要总结
Before they are born, babies are protected from hearing very loud noises by their mother's bodies. After delivery, they are exposed to many loud noises that are potentially harmful. These noises happen in the neonatal intensive care unit (NICU). The purpose of this research project is to test the fit and the ease-of-use of a new device that may protect infant's hearing in the NICU.
详细描述
Despite the best efforts of Neonatal Intensive Care Unit (NICU) caregivers, vulnerable and fragile NICU patients are frequently exposed to noxious levels of noise from monitoring and respiratory equipment alarms, as well as from routine NICU care practices. Particularly detrimental to sleep and auditory development are patient exposures to high frequency noises that are specifically designed to alert NICU caregivers to important changes in patient status. This pilot study will help evaluate the fit, ergonomic design and the ease-of-use of a novel hearing protection system (special ear-muffs along with a unique attachment mechanism) specifically designed top diminish the transmission of high frequency noises to patients within the NICU, while allowing some transmission of low frequency sounds, such as a mother's voice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Hours 至 2 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonate admitted to the Neonatal Intensive Care Unit
- •Age greater than 12 hours and less than 2 weeks
- •Informed consent from the parent(s)
排除标准
- •Significant cranial trauma noted on admission
- •Congenital anomalies of the head and/or neck
- •Hemodynamic instability requiring pharmacologic intervention
- •Recommendation by the attending neonatologist not to enroll the patient
研究组 & 干预措施
Neonates
Neonates admitted to the NICU will be fitted for NEATCAP, non-invasive novel hearing protection device.
干预措施: NEATCAP (Device)
结局指标
主要结局
Number of Participants With Skin Erythema After Device Application
时间窗: Skin erythema was evaluated at the time of device removal after 1 hour of application in phase #1 and after 3 daily 8 hour periods of application in phase #2.
Skin will be assessed for adverse effects such as any device-related adverse events, including evidence of skin redness, rash and/or bruising or discomfort at the site of device application. Skin erythema was described as none, mild, moderate or severe as evaluated by the NICU nursing staff.
次要结局
- Number of Participants With Specific Responses to the Ease of Use Questionnaire for NICU Staff.(After 1 hour in phase #1 / After 3 x 8 hours in phase #2)
研究者
Michael Balsan, MD
Associate Professor of Pediatrics
University of Pittsburgh