CompletedNot Applicable

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

United States134 participantsStarted 2018-11-13

Plain-language 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.

Who can participate

Age range

36 Weeks – 56 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Nociception-specific Brain Activity

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

Trial details

NCT IDNCT04050384

SponsorLance M Relland, MD, PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-01-23

Results submitted2023-09-05

View on ClinicalTrials.gov More Infant, Newborn trials