N/A
N=134
Effect of a Vibratory Stimulus on Mitigating Nociception-specific Responses to Skin Puncture in Neonates
Infant, Newborn · Infant, Premature · Pain Perception · Pain Measurement · Pain Management
Bottom Line
View on ClinicalTrials.gov: NCT04050384 ↗Enrolled (actual)
134
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Change in Nociception-specific Brain Activity — 17.9; 9.9; 11.5; 10.2 microvolts*milliseconds — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Baby GentleStick (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Lance M Relland, MD, PhD
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Nociception-specific Brain Activity |
17.9; 9.9; 11.5; 10.2; 12.2; 12.0 | <0.001 sig |
| SECONDARY Change in Facial Expression |
4; 4 | 0.38 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04050384). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.