Clinical trial NCT04050384: Effect of a Vibratory Stimulus on Mitigating Nociception-specific Responses to Skin Puncture in Neonates
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Newborn
Infant, Premature
Pain Perception
Pain Measurement
Pain Management
Electroencephalography
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2019-08-08
Enrollment: 134
Sex: ALL
Minimum age (years): 36
Maximum age (years): 56
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Nociception-specific Brain Activity
timeFrame: EEG-based responses are very brief, so the relevant assessment window is 350-700 ms after stimulus
Secondary outcomes:
measure: Change in Facial Expression
timeFrame: Assessment of facial expression is done based on video clips that are synchronized with the ERP window of 350-700ms after stimulus
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Lance Relland, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grunau RE, Oberlander T, Holsti L, Whitfield MF. Bedside application of the Neonatal Facial Coding System in pain assessment of premature neonates. Pain. 1998 Jun;76(3):277-286. doi: 10.1016/S0304-3959(98)00046-3.
citation: Maitre NL, Stark AR, McCoy Menser CC, Chorna OD, France DJ, Key AF, Wilkens K, Moore-Clingenpeel M, Wilkes DM, Bruehl S. Cry presence and amplitude do not reflect cortical processing of painful stimuli in newborns with distinct responses to touch or cold. Arch Dis Child Fetal Neonatal Ed. 2017 Sep;102(5):F428-F433. doi: 10.1136/archdischild-2016-312279. Epub 2017 May 12.
citation: Relland LM, Gehred A, Maitre NL. Behavioral and Physiological Signs for Pain Assessment in Preterm and Term Neonates During a Nociception-Specific Response: A Systematic Review. Pediatr Neurol. 2019 Jan;90:13-23. doi: 10.1016/j.pediatrneurol.2018.10.001. Epub 2018 Oct 10.