Effect of a Vibratory Stimulus on Mitigating Nociception-specific Responses to Skin Puncture in Neonates

Lance M Relland, MD, PhD134 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

134

Conditions

Infant, Newborn

Eligibility

Sex: ALLMin age: 36 WeeksMax age: 56 WeeksHealthy volunteers:

Medical Language ↔ Plain English

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

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.

Time frame: EEG-based responses are very brief, so the relevant assessment window is 350-700 ms after stimulus

Secondary Outcomes

Change in Facial Expression

Components from the Neonatal Facial Coding System (NFCS) use facial actions to monitor pain in newborn infants. Facial actions that occur each score 1 point, while those that do not occur each score 0 points (better outcome). This study applied 7 facial actions and may therefore score between 0 and 7. A higher score (worse outcome) is interpreted as a higher pain intensity. Comparison of median scores between groups will determine the effect of the intervention, which should result in a lower score to represent mitigation of pain.

Time frame: Assessment of facial expression is done based on video clips that are synchronized with the ERP window of 350-700ms after stimulus