Safety of Noninvasive Electrical Stimulation of Acupuncture Points (NESAP) in Infants

Completed · Not applicable

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT01495286

Run by

University of Arkansas

People needed

30

Starts

2011-12-01

Expected to finish

2012-07-01

Last updated by the study team

2012-11-19

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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