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 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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Is the Use of Noninvasive Electrical Stimulation of Acupuncture Points (NESAP) During a Routine Heelstick Safe in Infants?|
- Heart Rate During Treatment With TENS Unit [ Time Frame: Duration of the TENS unit treatment and heel stick, an expected average of 20 minutes. ] [ Designated as safety issue: Yes ]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.
- Oxygen Saturation During Treatment With TENS Unit and Routine Heel Stick [ Time Frame: Baseline, duration of the TENS unit treatment and heel stick, an expected average of 20 minutes. ] [ Designated as safety issue: Yes ]Changes in oxygen saturation after an initial baseline oxygen saturation. Oxygen saturation will be measured after TENS unit is initiated, for 10 minutes between TENS initiation and heel stick,during heel stick, and for 5 minutes afterwards. Measurements will be taken at baseline, after 5 minutes of NESAP, and at 5 minutes after end of heel stick.
- Blood Pressure During TENS Treatment and Heel Stick [ Time Frame: Duration of the TENS unit treatment and heel stick, an expected average of 20 minutes. ] [ Designated as safety issue: Yes ]Changes in systolic and diastolic blood pressure after initial baseline. Measurements 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.
- Pain During TENS Treatment and Routine Heel Stick [ Time Frame: Pain score given during the heel stick process and for 2 minutes afterwards ] [ Designated as safety issue: Yes ]Pain scores were measured using the Premature Infant Pain Profile (PIPP). The PIPP is a composite pain tool that measures pain based on behavioral and physiologic parameters and adjusts for gestational age. Differences in pain scores were recorded throughout the heel stick process, using a baseline score as reference. Mean pain scores were calculated before NESAP (baseline), after the TENS unit was turned on, after ten minutes of NESAP but before heel stick, during heel cleaning, during the initial heel stick, during heel squeeze, and during recovery. For term infants, the range of PIPP scores is on a scale of 0 for no pain to 18 for severe pain. A score of 6 indicate mild pain, and a score of 11 -12 indicates moderate pain. An increase in PIPP score of 4 or greater from baseline indicates a significant change in pain level.
- Skin Assessment [ Time Frame: Post procedure monitoring for the duration of the hospital stay, an expected average of 1 day. Follow up phone calls at one week and again at two weeks if needed. ] [ Designated as safety issue: Yes ]Areas of skin where the Stim Care electrodes are placed will be assessed for redness, tenderness, or any other change in skin condition. Assessment will take place at baseline, after the NESAP procedure, upon discharge from the hospital, and after one week. If there is a problem at one week, there will be additional follow-up at two weeks.
|Study Start Date:||December 2011|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Device: EMPI Select Transcutaneous Electrical Nerve Stimulation
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495286
|United States, Arkansas|
|University of Arkansas for Medical Sciences|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||Richard Hall, MD||University of Arkansas|