Effect of a Vibratory Stimulus on the Mitigation of Nociception-specific Behavioral and Electroencephalographic Responses to Skin Puncture in Neonates: a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Change in Nociception-specific Brain Activity
研究概览
简要总结
The assessment and treatment of pain in neonates remains a challenge. In an effort to improve the quality of care while limiting opioid-related adverse effects, this study aims to determine the efficacy of a non-pharmacological intervention on the mitigation of nociception-specific responses to a skin breaking procedure in term and preterm neonates. Such responses will be measured using behavioral measures as well as with electroencephalography-based methods.
详细描述
Eligible neonates who are 36-56 weeks post-menstrual age and who are scheduled to undergo a clinically required heel lance will be studied after obtaining appropriate verbal and written consent from the respective parents. Subjects will be monitored during a baseline resting state, during vibratory stimuli alone, and during a heel lance that is randomized to be preceded or not preceded by the vibratory stimulus. The sessions will include time-locked video recordings and electroencephalography using a specialized net of 128 electrodes (Electrical Geodesics Inc., EGI; Eugene, OR). Behavioral and cortical responses will be then be analyzed in a blinded fashion to determine the efficacy of the vibratory intervention, as well as to validate what behavioral responses are most correlated with nociception-specific cortical activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Personnel who code the video recording for behavioral measures and analysis of the electroencephalographic readings will be done in a blinded and/or independent fashion.
入排标准
- 年龄范围
- 36 Weeks 至 56 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Neonatal Intensive Care Unit patient
- •Between 36 to 56 weeks post-menstrual age
- •Medically stable
- •Due to have a clinically required bedside heel stick as part of their routine care
排除标准
- •Congenital anomalies or abnormalities affecting the brain
- •Patient is over 4 months corrected age
- •Infants who receive analgesics or sedatives within 72 hours prior to assessment
- •Administration of maternal analgesics or sedatives to which the infant may be exposed
研究组 & 干预措施
No vibratory stimulus before or during heel lance
Baseline measurements and readings after vibration alone will be done, but no vibratory stimulus will be provided immediately preceding or during heel lance.
Vibratory stimulus before and during heel lance
Baseline measurements and readings after vibration alone will be done, as well as a vibratory stimulus that will be provided immediately preceding and during heel lance.
干预措施: Baby GentleStick (Device)
结局指标
主要结局
Change in Nociception-specific Brain Activity
时间窗: EEG-based responses are very brief, so the relevant assessment window is 350-700 ms after stimulus
Electroencephalography (EEG)-based measurements will be done to detect changes in nociception-specific cortical activity. Recordings will be done using a high-density array of 128 electrodes embedded in soft sponges (Electrical Geodesics, Inc. (EGI); Eugene, Oregon, USA) soaked in warm saline and applied to the infant's head to record event-related potentials (ERPs) with a sampling rate of 1000 Hz, filters set to 0.1-400 Hz. As per published protocols, the midline Cz electrode will be used as the reference. Previous studies have also determined the EEG-based nociception-specific response to occur 350-700 ms after the stimulus. Changes in the amplitude of the signal during this time frame is the primary outcome measure.
次要结局
- Change in Facial Expression(Assessment of facial expression is done based on video clips that are synchronized with the ERP window of 350-700ms after stimulus)
研究者
Lance M Relland, MD, PhD
Assistant Professor
Nationwide Children's Hospital