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

NCT01495286 | Completed Results DMC

• 1 other identifier: 114283
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

newborn infant; acupuncture; safety; pain

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Secondary Outcomes (3)

• Blood Pressure During TENS Treatment and Heel Stick

  Duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.

• Pain During TENS Treatment and Routine Heel Stick

  Pain score given during the heel stick process and for 2 minutes afterwards

• Skin Assessment

  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.

Interventions

EMPI Select Transcutaneous Electrical Nerve Stimulation DEVICE

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.

Also known as: Noninvasive electrical stimulation

Eligibility Criteria

• Age: 1 Day - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• University of Arkansas: lead
• Stanford University: collaborator

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This was a small pilot study to determine safety of a TENS unit to deliver NESAP to newborn infants during routine heel sticks. The purpose was not to determine efficacy of NESAP to relieve pain during heel sticks. A large clinical trial will follow.

Results Point of Contact

• Title: Anita Mitchell PhD, coinvestigator
• Organization: University of Arkansas

AMitchell@uams.edu

501-686-7021

Study Officials

• Richard Hall, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2011
• First Posted: December 20, 2011
• Study Start: December 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: November 19, 2012
• Results First Posted: November 19, 2012

Record last verified: 2012-10

Locations

US (1)