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

Pain Management Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04050384
• Other study ID #: IRB18-00779
• Status: Completed
• Phase: N/A
• Start date: November 13, 2018
• Est. completion date: January 23, 2020

Study information

• Verified date: November 2023
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: January 23, 2020
• Est. primary completion date: January 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 36 Weeks to 56 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Electroencephalography
• Infant, Newborn
• Infant, Premature
• Pain Management
• Pain Measurement
• Pain Perception

Intervention

Device:
• Baby GentleStick
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.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Lance M Relland, MD, PhD

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	EEG-based responses are very brief, so the relevant assessment window is 350-700 ms after stimulus
Secondary	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.	Assessment of facial expression is done based on video clips that are synchronized with the ERP window of 350-700ms after stimulus