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Completed

NCT Number: NCT04050384

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

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.

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Key information

Conditions

Infant, Newborn Agnosia Electroencephalography Female Urogenital Diseases and Pregnancy Complications Infant, Premature Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Obstetric Labor Complications Obstetric Labor, Premature Pain Management Pain Measurement Pain Perception Pathological Conditions, Signs and Symptoms Perceptual Disorders Pregnancy Complications Premature Birth Signs and Symptoms Urogenital Diseases

Age range

36 week–56 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baby GentleStick

Device

The Baby GentleStick is a handheld device that fits and provides vibration to an Owen Mumford Unistik3 Dual lancet. The gentle vibration occurs at 178 Hertz with a free-hanging 0.24 mm range of motion. The device may provide vibration alone and also allow for simultaneous vibration and deployment of the lancet.

Primary outcomes

  1. 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

  1. Change in Facial Expression

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

    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.

Sponsors and collaborators

Lead sponsor

Lance M Relland, MD, PhD

Other

Registry information

Official study title

Effect of a Vibratory Stimulus on the Mitigation of Nociception-specific Behavioral and Electroencephalographic Responses to Skin Puncture in Neonates: a Randomized Control Trial

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 8, 2019
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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