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

Pain Clinical Trial

Official title:

Is the Use of Noninvasive Electrical Stimulation of Acupuncture Points (NESAP) During a Routine Heelstick Safe in Infants?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01495286
• Other study ID #: 114283
• Status: Completed
• Phase: N/A
• First received: December 9, 2011
• Last updated: October 18, 2012
• Start date: December 2011
• Est. completion date: July 2012

Study information

• Verified date: October 2012
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Days

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• EMPI Select Transcutaneous Electrical Nerve Stimulation
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.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate During Treatment With TENS Unit	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.	Duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.	Yes
Primary	Oxygen Saturation During Treatment With TENS Unit and Routine Heel Stick	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.	Baseline, duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.	Yes
Secondary	Blood Pressure During TENS Treatment and Heel Stick	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.	Duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.	Yes
Secondary	Pain During TENS Treatment and Routine Heel Stick	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.	Pain score given during the heel stick process and for 2 minutes afterwards	Yes
Secondary	Skin Assessment	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.	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.	Yes