Trial Outcomes & Findings for Effect of a Vibratory Stimulus on Mitigating Nociception-specific Responses to Skin Puncture in Neonates (NCT NCT04050384)

Last Updated: 2023-11-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

134 participants

Primary outcome timeframe

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

Results posted on

2023-11-29

Participant Flow

Participant milestones

Participant milestones
Measure	No Vibratory Stimulus Before or During Heel Lance 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 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. 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.
Overall Study STARTED	67	67
Overall Study COMPLETED	67	67
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data attrition is due to background noise in EEG signal.

Baseline characteristics by cohort

PRIMARY outcome

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

Population: Subjects who had usable, artifact-free EEG data.

Outcome measures

Outcome measures
Measure	No Vibratory Stimulus Before or During Heel Lance n=40 Participants 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 n=41 Participants 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. 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.
Change in Nociception-specific Brain Activity Frontal	17.9 microvolts*milliseconds Standard Deviation 39.5	9.9 microvolts*milliseconds Standard Deviation 17.1
Change in Nociception-specific Brain Activity Central	11.5 microvolts*milliseconds Standard Deviation 12.1	10.2 microvolts*milliseconds Standard Deviation 6.8
Change in Nociception-specific Brain Activity Central Parietal	12.2 microvolts*milliseconds Standard Deviation 15.4	12.0 microvolts*milliseconds Standard Deviation 12.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	No Vibratory Stimulus Before or During Heel Lance n=40 Participants 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 n=41 Participants 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. 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.
Change in Facial Expression	4 units on a scale Interval 2.75 to 5.0	4 units on a scale Interval 3.0 to 5.0

Adverse Events

No Vibratory Stimulus Before or During Heel Lance

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vibratory Stimulus Before and During Heel Lance

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lance M. Relland

Nationwide Children's Hospital

Phone: 614-722-5971

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	No Vibratory Stimulus Before or During Heel Lance n=67 Participants 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 n=67 Participants 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. 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.	Total n=134 Participants Total of all reporting groups
Age, Continuous	39.5 weeks n=40 Participants • Data attrition is due to background noise in EEG signal.	39.1 weeks n=41 Participants • Data attrition is due to background noise in EEG signal.	39.4 weeks n=81 Participants • Data attrition is due to background noise in EEG signal.
Sex: Female, Male Female	17 Participants n=40 Participants • Analysis was limited to those with a usable EEG signal.	14 Participants n=41 Participants • Analysis was limited to those with a usable EEG signal.	31 Participants n=81 Participants • Analysis was limited to those with a usable EEG signal.
Sex: Female, Male Male	23 Participants n=40 Participants • Analysis was limited to those with a usable EEG signal.	27 Participants n=41 Participants • Analysis was limited to those with a usable EEG signal.	50 Participants n=81 Participants • Analysis was limited to those with a usable EEG signal.
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=40 Participants • Analysis was limited to those with a usable EEG signal.	1 Participants n=41 Participants • Analysis was limited to those with a usable EEG signal.	1 Participants n=81 Participants • Analysis was limited to those with a usable EEG signal.
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=40 Participants • Analysis was limited to those with a usable EEG signal.	40 Participants n=41 Participants • Analysis was limited to those with a usable EEG signal.	80 Participants n=81 Participants • Analysis was limited to those with a usable EEG signal.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=40 Participants • Analysis was limited to those with a usable EEG signal.	0 Participants n=41 Participants • Analysis was limited to those with a usable EEG signal.	0 Participants n=81 Participants • Analysis was limited to those with a usable EEG signal.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=40 Participants • Analysis was limited to those with a usable EEG signal.	0 Participants n=41 Participants • Analysis was limited to those with a usable EEG signal.	0 Participants n=81 Participants • Analysis was limited to those with a usable EEG signal.
Race (NIH/OMB) Asian	2 Participants n=40 Participants • Analysis was limited to those with a usable EEG signal.	2 Participants n=41 Participants • Analysis was limited to those with a usable EEG signal.	4 Participants n=81 Participants • Analysis was limited to those with a usable EEG signal.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=40 Participants • Analysis was limited to those with a usable EEG signal.	0 Participants n=41 Participants • Analysis was limited to those with a usable EEG signal.	0 Participants n=81 Participants • Analysis was limited to those with a usable EEG signal.
Race (NIH/OMB) Black or African American	3 Participants n=40 Participants • Analysis was limited to those with a usable EEG signal.	3 Participants n=41 Participants • Analysis was limited to those with a usable EEG signal.	6 Participants n=81 Participants • Analysis was limited to those with a usable EEG signal.
Race (NIH/OMB) White	29 Participants n=40 Participants • Analysis was limited to those with a usable EEG signal.	31 Participants n=41 Participants • Analysis was limited to those with a usable EEG signal.	60 Participants n=81 Participants • Analysis was limited to those with a usable EEG signal.
Race (NIH/OMB) More than one race	6 Participants n=40 Participants • Analysis was limited to those with a usable EEG signal.	5 Participants n=41 Participants • Analysis was limited to those with a usable EEG signal.	11 Participants n=81 Participants • Analysis was limited to those with a usable EEG signal.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=40 Participants • Analysis was limited to those with a usable EEG signal.	0 Participants n=41 Participants • Analysis was limited to those with a usable EEG signal.	0 Participants n=81 Participants • Analysis was limited to those with a usable EEG signal.
Region of Enrollment United States	40 participants n=40 Participants • Analysis was limited to those with a usable EEG signal.	41 participants n=41 Participants • Analysis was limited to those with a usable EEG signal.	81 participants n=81 Participants • Analysis was limited to those with a usable EEG signal.
Facial Score	0 units on a scale n=67 Participants	0 units on a scale n=67 Participants	0 units on a scale n=134 Participants