Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No vibratory stimulus before or during heel lance | No Intervention | 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 | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lance Relland, MD, PhD | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9718246 | Background | 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. | |
| 28500064 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Vibratory Stimulus Before and During Heel Lance |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 19, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
Personnel who code the video recording for behavioral measures and analysis of the electroencephalographic readings will be done in a blinded and/or independent fashion.
|
| Assessment of facial expression is done based on video clips that are synchronized with the ERP window of 350-700ms after stimulus |
| 30449602 | Background | 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. |
| 38479794 | Derived | Relland LM, Kjeldsen CP, Jeanvoine A, Emery L, Adderley K, Srinivas R, McLoughlin M, Maitre NL. Vibration-based mitigation of noxious-evoked responses to skin puncture in neonates and infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2024 Oct 18;109(6):622-627. doi: 10.1136/archdischild-2023-326588. |
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. |
| COMPLETED |
|
| NOT COMPLETED |
|
Total number of final analysis patients may be lower due to attrition of data.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Post-conceptional | Data attrition is due to background noise in EEG signal. | Median | Inter-Quartile Range | weeks |
| |||||||||||||
| Sex: Female, Male | Analysis was limited to those with a usable EEG signal. | Count of Participants | Participants |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Analysis was limited to those with a usable EEG signal. | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | Analysis was limited to those with a usable EEG signal. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Analysis was limited to those with a usable EEG signal. | Number | participants |
| |||||||||||||||
| Facial Score | The Facial Score in this study is an adaptation of the established Neonatal Facial Coding System (NFCS) such that seven predetermined components of NFCS are assessed to generate a score that could range from 0 to 7 and for which lower to higher values represent better to worse outcomes, respectively. Of note, a zero value score is meaningful and valid in this case, which makes it possible to yield a median value of zero. | Median | Inter-Quartile Range | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Subjects who had usable, artifact-free EEG data. | Posted | Mean | Standard Deviation | microvolts*milliseconds | 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. | Posted | Median | Inter-Quartile Range | units on a scale | Assessment of facial expression is done based on video clips that are synchronized with the ERP window of 350-700ms after stimulus |
|
From the time of the clinically required lab draw session to the time the lab results were obtained, all occurred within the same day.
This study involved only placing a soft sponge cap on the head +/- applying a vibratory stimulus to the surface of the skin while performing a standard heel stick for clinically required lab draws.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 67 | 0 | 67 | 0 | 67 |
| EG001 | 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. | 0 | 67 | 0 | 67 | 0 | 67 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lance M. Relland | Nationwide Children's Hospital | 614-722-5971 | lance.relland@nationwidechildrens.org |
| Oct 16, 2023 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 19, 2018 | Oct 17, 2022 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
|
|
|
|
|
| Central Parietal |
|
|
|
|