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

NCT ID: NCT04050384

Last Updated: 2023-11-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-13

Study Completion Date

2020-01-23

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Baby GentleStick

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

36 Weeks

Maximum Eligible Age

56 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lance M Relland, MD, PhD

OTHER

Sponsor Role lead

Responsible Party

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Lance M Relland, MD, PhD

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lance Relland, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 9718246 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28500064 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30449602 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38479794 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB18-00779

Identifier Type: -

Identifier Source: org_study_id