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NCT01495286 · ClinicalTrials.gov registry record · NA
Safety of Noninvasive Electrical Stimulation of Acupuncture Points (NESAP) in Infants
A NA study, sponsored by University of Arkansas.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT01495286 is a NA study that has completed, run by University of Arkansas. The registered enrollment target is 30 participants.
The verdict
NCT01495286, a NA study, has completed, sponsored by University of Arkansas.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
This research study represents a pilot, open arm study that will evaluate the safety of using Non-invasive Electrical Stimulation of Acupuncture Points (NESAP) in 42 newborn infants less than 3 days of age who require heel sticks for clinical blood sampling. The investigators plan to enroll 51 infants into the study in order to obtain 42 completed infants. Two sub studies will precede the main safety study, with 6 infants in each sub study and 30 infants in the main study. These two sub studies will use electrical stimulation intensities that are a fraction of the planned intensity of electrical stimulation that will be used during the main part of the study. The clinical trial will be performed at the University of Arkansas for Medical Sciences Hospital (Little Rock, AR). The study will evaluate the pain response to heel stick routinely used to obtain This blood from 30 term neonatal infants, ages 37 to 42 weeks Electrical stimulation will be applied at appropriate acupuncture points using a very low current for 10 minutes, routine for procedural pain. The response to pain will be assessed using pain scales and physiologic changes. The investigators hypothesize that the NESAP procedure is safe in newborn infants undergoing a routine heelstick.
Interventions
- DEVICE EMPI Select Transcutaneous Electrical Nerve Stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-12 |
| Est. Completion | 2012-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01495286
The ClinicalTrials.gov registry entry for NCT01495286 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arkansas, which has 318 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which EMPI Select Transcutaneous Electrical Nerve Stimulation is the first listed.
NCT01495286 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01495286 about?
NCT01495286 is a clinical study titled "Safety of Noninvasive Electrical Stimulation of Acupuncture Points (NESAP) in Infants". This research study represents a pilot, open arm study that will evaluate the safety of using Non-invasive Electrical Stimulation of Acupuncture Points (NESAP) in 42 newborn infants less than 3 days of age who require heel sticks for clinical blood sampling. The investigators plan to enroll 51 infan...
What is the current status of trial NCT01495286?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2011-12. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01495286?
The interventions under investigation include: EMPI Select Transcutaneous Electrical Nerve Stimulation (DEVICE).
Who is sponsoring clinical trial NCT01495286?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
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