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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Columbus, Ohio, United States
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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