Status:
COMPLETED
Safety of Noninvasive Electrical Stimulation of Acupuncture Points (NESAP) in Infants
Lead Sponsor:
University of Arkansas
Collaborating Sponsors:
Stanford University
Conditions:
Pain
Eligibility:
All Genders
1-3 years
Phase:
NA
Brief 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 o...
Detailed Description
The investigators propose an open label trial to assess the safety of using electrical stimulation at acupuncture sites in 42 infants receiving a routine heel stick. Two sub studies will precede the m...
Eligibility Criteria
Inclusion
- Newborn infants born at 37-42 weeks gestational age and less than 3 days of age requiring a heelstick for clinically indicated blood sampling.
- A normal neurological assessment
Exclusion
- Newborns who have received any analgesic treatment
- Infants exposed to chronic opiates in utero (excluding opiates given only at the time of delivery) or with a positive drug screen based on review of medical records
- Infants exposed to birth asphyxia (5-minute Apgar scores of \<5 or cord pH \<7.0).
- Infants on mechanical ventilation.
- Newborns with suspected or confirmed neuromuscular diseases, congenital anomalies, or sepsis.
- Infants with birth trauma to the lower extremities (bruising or other) or those exposed multiple heelsticks in the previous 24 hours (e.g. requiring frequent glucose or bilirubin measurements).
- Infants born from mothers with drug addiction, diabetes, pre-eclampsia, or systemic inflammatory conditions.
- Infants with abnormal neurological exams
- Infants with congenital heart defects
- Any condition the investigator determines will put the subject at risk if participating in the study.
- Enrollment / participation in other studies
- Dermatological condition(s) in the area of electrode placement or elsewhere
- Local or systemic infection documented or suspected
- Allergy to the gel or adhesive
- Bleeding abnormalities
- Connection to other medical equipment or devices that may interfere with the workings or functioning of the TENS unit
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01495286
Start Date
December 1 2011
End Date
July 1 2012
Last Update
November 19 2012
Active Locations (1)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205