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

NCT04050384 | Completed Results FDA Device

• 1 other identifier: IRB18-00779
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Facial Expression

  Assessment of facial expression is done based on video clips that are synchronized with the ERP window of 350-700ms after stimulus

Study Arms (2)

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.

Device: Baby GentleStick

Interventions

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.

Vibratory stimulus before and during heel lance

Eligibility Criteria

• Age: 36 Weeks - 56 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lance M Relland, MD, PhD: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (4)

• 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.

  PMID: 9718246 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.

  PMID: 28500064 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.

  PMID: 30449602 BACKGROUND

• 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.

  PMID: 38479794 DERIVED

MeSH Terms

Conditions

Premature Birth; Agnosia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Lance M. Relland
• Organization: Nationwide Children's Hospital

lance.relland@nationwidechildrens.org

614-722-5971

Study Officials

• Lance Relland, MD, PhD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: August 8, 2019
• Study Start: November 13, 2018
• Primary Completion: January 23, 2020
• Study Completion: January 23, 2020
• Last Updated: November 29, 2023
• Results First Posted: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)