Effect of a Vibratory Stimulus on the Mitigation of Nociception-specific Behavioral and Electroencephalographic Responses to Skin Puncture in Neonates: a Randomized Control Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Infant, Newborn
- Sponsor
- Lance M Relland, MD, PhD
- Enrollment
- 134
- Locations
- 1
- Primary Endpoint
- Change in Nociception-specific Brain Activity
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Lance M Relland, MD, PhD
Assistant Professor
Nationwide Children's Hospital
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change in Nociception-specific Brain Activity
Time Frame: 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.
Secondary Outcomes
- 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)