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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: Completed NA study, sponsored by University of Arkansas.
NCT01495286 is a NA study that has completed, run by University of Arkansas. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Changes in heart rate will be recorded after an initial baseline heart rate. Heart rate will be taken at baseline, after 5 minutes of NESAP, at 5 minutes after end of heel stick, and upon return to infant's room.
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 |
What the finished NCT01495286 record still lists
NCT01495286 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which EMPI Select Transcutaneous Electrical Nerve Stimulation is the first listed.
NCT01495286 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01495286's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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