Safety of Noninvasive Electrical Stimulation of Acupuncture Points (NESAP) in Infants
Condition: Pain
Study type: Interventional

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.
    

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 main safety study, with 6 infants in each sub study and 30 infants
      in the main study. These sub studies will use electrical stimulation intensities that are a
      fraction of the planned intensity of the electrical stimulation that will be used for the
      main part of the study.

      As part of routine neonatal screening, blood will be collected from a heel stick(s) by
      qualified nursing staff in the hospital nursery or in the patient's room. Less than one ml of
      blood will be drawn over 1-2 minutes. Study infants will be watched more carefully with heart
      rate, respiratory rate, and oxygen saturation performed as part of this study. Infants not
      participating in the study will be watched as per usual unit protocol.

      Electrical stimulation at acupuncture sites will be administered via an EMPI Select
      Transcutaneous Electrical Nerve Stimulation (TENS) unit. To produce analgesia, small
      electrodes will be placed on the baby's legs at specific acupuncture points: ZuSanLi (ST36)
      just below the knee, triggers release of endorphins; SanYinJiao (SP6) just above the inner
      ankle, important point for energy balance; Kun Lun (BL60) depression behind lateral
      malleolus, protects local tissue trauma to heel; and Tai Xi (Ki3) behind the inner ankle, an
      important energy meridian. 25, 39, 48-50, StimCare self-adhesive electrodes with a gel base
      will be applied to the skin; the skin will not be punctured by these procedures. For the main
      part of the study, a low continuous current will be provided with minimal voltage of 3.5
      milliamps (mA). The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes
      prior to the heelstick, with continued stimulation during and for 5±1 min after the
      heelstick. This paradigm is based on the basic animal research developed by Dr. Han and other
      research groups. Two sub studies will precede the main safety study, with 6 infants in each
      sub study, using electrical stimulation intensities that are a fraction of the planned
      intensity. Infants in sub study 1 will receive electrical stimulation at 1 mA and 2 Hz.
      Infants in sub study 2 will receive electrical stimulation at 2 mA and 10 Hz.
    

Intervention name(s): EMPI Select Transcutaneous Electrical Nerve Stimulation
Intervention type(s): Device
Intervention description(s): Experimental: EMPI Select TENS unit For analgesia, StimCare electrodes will be placed on the baby's legs at specific acupuncture points and electrical stimulation will be administered via a standard EMPI Select TENS unit. For the main study, a low continuous current will be provided with voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 5±1 min after the heel stick. Two sub studies will precede the main safety study, with 6 infants in each, using electrical stimulation intensities that are a fraction of the planned intensity. Infants in sub study 1 will receive electrical stimulation at 1 mA and 2 Hz. Infants in sub study 2 will receive electrical stimulation at 2 mA and 10 Hz.
Other intervention name(s): Noninvasive electrical stimulation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: newborn infant; acupuncture; safety; pain