Feasibility of Auricular Acupressure as an Adjunct Treatment for Neonatal Abstinence Syndrome (NAS)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neonatal Abstinence Syndrome
- Sponsor
- Vanderbilt University Medical Center
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Percent of eligible patients enrolled
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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).
Detailed Description
NAS is a condition in which newborns experience withdrawal symptoms as a result of in utero exposure to opioids and/or other substances ingested by the mother. The condition has significantly risen over the past 20 years. First line treatments for NAS involve the maximization of non-pharmacologic therapies. NAS management focuses on reducing or eliminating the need for medication management to prevent further developmental complications, promote maternal bonding, and reduce hospital length of stay. Auricular acupuncture has been used for the treatment of addiction and has demonstrated efficacy in the adult population. Current evidence suggests that acupuncture is safe and beneficial for multiple conditions that impact neonatal and pediatric populations including NAS. Acupressure is a less invasive therapy and may serve as an additional non-pharmacological adjunct to ease the severe discomfort of withdrawal in neonates at risk for NAS. 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).
Investigators
Heather Jackson
Associate in Anesthesiology, Division of Pain Medicine
Vanderbilt University Medical Center
Eligibility Criteria
Inclusion Criteria
- •37 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
Exclusion Criteria
- •Birth trauma
- •Neonatal asphyxia
- •Maternal or neonatal infection
- •Congenital abnormalities
- •Requiring Neonatal Intensive Care Unit (NICU) care
Outcomes
Primary Outcomes
Percent of eligible patients enrolled
Time Frame: end of study enrollment (about 12 weeks)
Percent of patients prematurely terminating treatment
Time Frame: hospital discharge (about 48-72 hours after delivery)
Percent of missing medical record data
Time Frame: hospital discharge (about 48-72 hours after delivery)
Percent of participants completing all study assessments
Time Frame: hospital discharge (about 48-72 hours after delivery)
Percent of data collection procedures completed
Time Frame: hospital discharge (about 48-72 hours after delivery)
Secondary Outcomes
- Client Satisfaction Questionnaire (CSQ*) Score(Day of discharge (about 48-72 hours after delivery))
- Percent of providers enrolled in 3 day training course for 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))
- Intervention Appropriateness Measure (IAM) Score(Day of hospital discharge of baby (about 48-72 hours after delivery))
- Acceptability of Intervention Measure (AIM)(Day of hospital discharge of baby (about 48-72 hours after delivery))
- Feasibility of Intervention Measure (FIM)(Day of hospital discharge of baby (about 48-72 hours after delivery))
- 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))