Clinical trial NCT03973801: Feasibility of Auricular Acupressure as an Adjunct Treatment for Neonatal Abstinence Syndrome (NAS)
Official title: Feasibility of Auricular Acupressure as an Adjunct Treatment for Neonatal Abstinence Syndrome (NAS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Abstinence Syndrome
Withdrawal
Keywords: Acupressure
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
First posted: 2019-06-04
Enrollment: 12
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Percent of eligible patients enrolled
timeFrame: end of study enrollment (about 12 weeks)
measure: Percent of patients prematurely terminating treatment
timeFrame: hospital discharge (about 48-72 hours after delivery)
measure: Percent of participants completing all study assessments
timeFrame: hospital discharge (about 48-72 hours after delivery)
measure: Percent of data collection procedures completed
timeFrame: hospital discharge (about 48-72 hours after delivery)
measure: Percent of missing medical record data
timeFrame: hospital discharge (about 48-72 hours after delivery)
Secondary outcomes:
measure: Percent of providers enrolled in 3 day training course for NADA protocol
timeFrame: Prior to start of study enrollment (May 31, 2019)
measure: Percent of providers completing 3 day training course for NADA protocol
timeFrame: Day 3 of training
measure: Percent of providers completing clinical competency with NADA protocol
timeFrame: Prior to start of study enrollment (May 31, 2019)
measure: Percent of providers receiving NADA certification
timeFrame: Prior to start of study enrollment (May 31, 2019)
measure: Percent of providers receiving credentialing
timeFrame: Prior to start of study enrollment (May 31, 2019)
measure: Client Satisfaction Questionnaire (CSQ*) Score
timeFrame: Day of discharge (about 48-72 hours after delivery)
measure: Intervention Appropriateness Measure (IAM) Score
timeFrame: Day of hospital discharge of baby (about 48-72 hours after delivery)
measure: Acceptability of Intervention Measure (AIM)
timeFrame: Day of hospital discharge of baby (about 48-72 hours after delivery)
measure: Feasibility of Intervention Measure (FIM)
timeFrame: Day of hospital discharge of baby (about 48-72 hours after delivery)
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Heather Jackson, MSN
role: PRINCIPAL_INVESTIGATOR
References: