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Search / Trial NCT04050384

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

Launched by LANCE M RELLAND, MD, PHD · Aug 6, 2019

Trial Information

Current as of May 08, 2025

Completed

Keywords

ClinConnect Summary

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 ...

Gender

ALL

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

About Lance M Relland, Md, Phd

Dr. Lance M. Relland, MD, PhD, is a distinguished clinical trial sponsor with extensive expertise in medical research and drug development. With a robust background in both clinical practice and academic medicine, he is committed to advancing innovative therapeutic solutions through rigorous clinical trials. Dr. Relland's leadership is marked by a strong emphasis on patient safety, ethical research practices, and collaborative partnerships within the scientific community. His dedication to enhancing treatment modalities reflects a deep-seated passion for improving patient outcomes and contributing to the body of medical knowledge.

Locations

Columbus, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Lance Relland, MD, PhD

Principal Investigator

Nationwide Children's Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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