An Evaluation of the Neuromuscular Junction in Neonates Using the TetraGraph

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Joseph D. Tobias
Study ID
NCT07133412
Status
Not Yet Recruiting

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Conditions

  • Surgery

Eligibility Criteria

Sex
ALL
Age
28 Days - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • TetraGraph — DEVICE
    TetraGraph is a unique, EMG-based portable device for quantitative (objective) monitoring of neuromuscular function. It is a precise and easy to use tool for monitoring depth of block, ensuring adequate recovery of muscle function, and aiding the clinician to reduce the incidence of residual block.

Study Details

The goal of this study is to use electromyography-based train-of-four monitoring (TetraGraph™ Neuromuscular Transmission Monitor) as a means of evaluating differences in neuromuscular transmission between infants ≤ 3 months of age and adolescent and older patients (≥ 12 years of age).

Key Dates

Start date
Jul 31, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Infants
    Infants 28 days to 3 months old undergoing surgery.
  • Active Comparator: Adolescents
    Adolescents/young adults 12 years of age or above undergoing surgery.

Primary Outcome Measure

Amplitude [ Time Frame: First 30 minutes of surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nationwide Children's HospitalColumbusOhio43205
Julie Rice-Weimer, RN
614-355-3142
Joseph Tobias, MD (PRINCIPAL_INVESTIGATOR)

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