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

Lance M Relland, MD, PhD

Status: Completed

Conditions: Electroencephalography; Pain Perception; Infant, Newborn; Pain Management; Pain Measurement; Infant, Premature

Treatments: Device: Baby GentleStick

Study type: Interventional

Funder types: Other

Identifiers

NCT04050384

IRB18-00779

Details and patient eligibility

About

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.

Full 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.

Enrollment: 134 patients

Sex: All

Ages: 36 to 56 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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134 participants in 2 patient groups

No vibratory stimulus before or during heel lance

No Intervention group

Description:

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

Experimental group

Description:

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.

Treatment:

Device: Baby GentleStick