Clinical trial NCT01495286: Safety of Noninvasive Electrical Stimulation of Acupuncture Points (NESAP) in Infants
Official title: Is the Use of Noninvasive Electrical Stimulation of Acupuncture Points (NESAP) During a Routine Heelstick Safe in Infants?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: newborn infant
acupuncture
safety
pain
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2011-12-20
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Heart Rate During Treatment With TENS Unit
timeFrame: Duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.
measure: Oxygen Saturation During Treatment With TENS Unit and Routine Heel Stick
timeFrame: Baseline, duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.
Secondary outcomes:
measure: Blood Pressure During TENS Treatment and Heel Stick
timeFrame: Duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.
measure: Pain During TENS Treatment and Routine Heel Stick
timeFrame: Pain score given during the heel stick process and for 2 minutes afterwards
measure: Skin Assessment
timeFrame: 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.
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Richard Hall, MD
role: PRINCIPAL_INVESTIGATOR
References: