Feasibility of Auricular Acupressure as an Adjunct Treatment for Neonatal Abstinence Syndrome (NAS)

NCT03973801 | Completed

• 1 other identifier: 191023
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the feasibility of implementing auricular acupressure as an additional non-pharmacologic therapy for neonates at risk for developing neonatal abstinence syndrome (NAS) at Monroe Carrell Jr Children's Hospital at Vanderbilt University Medical Center (VUMC).

Conditions

Neonatal Abstinence Syndrome; Withdrawal

Keywords

Acupressure

Outcome Measures

Primary Outcomes (5)

• Percent of eligible patients enrolled

  end of study enrollment (about 12 weeks)

• Percent of patients prematurely terminating treatment

  hospital discharge (about 48-72 hours after delivery)

• Percent of participants completing all study assessments

  hospital discharge (about 48-72 hours after delivery)

• Percent of data collection procedures completed

  hospital discharge (about 48-72 hours after delivery)

• Percent of missing medical record data

  hospital discharge (about 48-72 hours after delivery)

Secondary Outcomes (9)

• Percent of providers enrolled in 3 day training course for NADA protocol

  Prior to start of study enrollment (May 31, 2019)

• Percent of providers completing 3 day training course for NADA protocol

  Day 3 of training

• Percent of providers completing clinical competency with NADA protocol

  Prior to start of study enrollment (May 31, 2019)

• Percent of providers receiving NADA certification

  Prior to start of study enrollment (May 31, 2019)

• Percent of providers receiving credentialing

  Prior to start of study enrollment (May 31, 2019)

Study Arms (1)

Auricular acupressure

EXPERIMENTAL

Other: Auricular acupuncture

Interventions

Auricular acupuncture OTHER

National Acupuncture Detoxification Association (NADA) protocol for auricular acupressure will be initiated within 24 hours of delivery and continued until withdrawal symptoms measure 6 or less for 12 hours on the modified Finnegan score and/or the morning of expected discharge as in line with standard of care.

Auricular acupressure

Eligibility Criteria

• Age: Up to 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• weeks gestational age or greater
• Maternal age 16 or older
• Substance exposure in utero including opioids, illicit drugs, or other medications that cause neonatal withdrawal

You may not qualify if:

• Birth trauma
• Neonatal asphyxia
• Maternal or neonatal infection
• Congenital abnormalities
• Requiring Neonatal Intensive Care Unit (NICU) care

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Medical University of South Carolina: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Neonatal Abstinence Syndrome

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Study Officials

• Heather Jackson, MSN

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate in Anesthesiology, Division of Pain Medicine

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 4, 2019
• Study Start: August 19, 2019
• Primary Completion: September 16, 2019
• Study Completion: September 16, 2019
• Last Updated: March 10, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)