Neonatal Abstinence SyndromeNCT03973801
Feasibility of Auricular Acupressure as an Adjunct Treatment for Neonatal Abstinence Syndrome (NAS)
A study testing Auricular acupuncture in people with Neonatal Abstinence Syndrome and Withdrawal, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 24 hours
- Conditions the study is for
- Neonatal Abstinence Syndrome, Withdrawal
- What is being tested?
- Auricular acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2019to 16 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Birth trauma
- Neonatal asphyxia
- Maternal or neonatal infection
- Congenital abnormalities
- Requiring Neonatal Intensive Care Unit (NICU) care
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
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).
Read the 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).
- Conditions
- Neonatal Abstinence Syndrome, Withdrawal
- Being tested
- Auricular acupuncture
- Keywords
- Acupressure
- Medical subject headings
- Neonatal Abstinence Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular acupunctureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Auricular acupressure | Experimental | Not described Receives: Other: Auricular acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of eligible patients enrolled
Measured: end of study enrollment (about 12 weeks)
Percent of patients prematurely terminating treatment
Measured: hospital discharge (about 48-72 hours after delivery)
Percent of participants completing all study assessments
Measured: hospital discharge (about 48-72 hours after delivery)
Percent of data collection procedures completed
Measured: hospital discharge (about 48-72 hours after delivery)
Percent of missing medical record data
Measured: hospital discharge (about 48-72 hours after delivery)
Secondary outcomes (9)
Percent of providers enrolled in 3 day training course for NADA protocol
Measured: Prior to start of study enrollment (May 31, 2019)
Percent of providers completing 3 day training course for NADA protocol
Percent of providers completing 3 day training course for NADA protocol: The training course includes a national, standardized curriculum, clinical demonstration and skills lab. Providers are trained in application of acupuncture needles which are placed at the same location as acupressure stickers.
Measured: Day 3 of training
Percent of providers completing clinical competency with NADA protocol
Percent of providers completing clinical competency with NADA protocol: Following the training course providers must submit pictures to the NADA instructor with a clinical log of 40 appropriately placed acupuncture needles in accordance with the NADA protocol. Training includes
Measured: Prior to start of study enrollment (May 31, 2019)
Percent of providers receiving NADA certification
Percent of providers receiving NADA certification: Once clinical practice is complete and verified by a NADA trainer, providers will receive a NADA certification
Measured: Prior to start of study enrollment (May 31, 2019)
Percent of providers receiving credentialing
Following certification of the providers, competency of acupressure placement on neonates for the specific study protocol will be demonstrated via simulation lab. Providers must perform the acupressure, in accordance with the NADA protocol, on a neonatal manikin, and documentation of the appropriate technique will be completed for credentialing purposes. Providers will submit the NADA certificate, a skills checklist that documents appropriate NADA technique on a neonate manikin, and a neonatal simulation lab certificate for credentialing to perform NADA protocol at VUMC.
Measured: Prior to start of study enrollment (May 31, 2019)
Client Satisfaction Questionnaire (CSQ*) Score
On day of discharge, the parent(s) will receive the Client Satisfaction Questionnaire (CSQ8) to assess parental satisfaction of acupuncture as an additional therapy. The CSQ8 is an 8 item measure of client satisfaction with services. Items are questions inquiring about respondents' opinions and conclusions about services they have received. Response options differ from item to item, but all are based on a four-point scale. The overall score is produced by summing all item responses. CSQ-8 version scores range from 8 to 32, with higher values indicating higher satisfaction.
Measured: Day of discharge (about 48-72 hours after delivery)
Intervention Appropriateness Measure (IAM) Score
Provider and staff acceptability of acupressure as an additional non-pharmacologic treatment will be measured with the Intervention Appropriateness Measure (IAM). The IAM is a four-item measure of the appropriateness of an intervention. Each item of the score is rated on a five point scale where 1 equals completely disagree and 5 equals completely agree. The total score ranges from 5 to 20, with a higher score indicating a higher level of appropriateness.
Measured: Day of hospital discharge of baby (about 48-72 hours after delivery)
Acceptability of Intervention Measure (AIM)
Provider and staff acceptability of acupressure as an additional non-pharmacologic treatment will be measured with the Acceptability of Intervention Measure (AIM). The AIM is a four-item measure of the acceptability of an intervention. Each item of the score is rated on a five point scale where 1 equals completely disagree and 5 equals completely agree. The total score ranges from 5 to 20, with a higher score indicating a higher level of acceptability.
Measured: Day of hospital discharge of baby (about 48-72 hours after delivery)
Feasibility of Intervention Measure (FIM)
Provider and staff acceptability of acupressure as an additional non-pharmacologic treatment will be measured with the Feasibility of Intervention Measure (FIM). The FIM is a four-item measure of the feasibility of an intervention. Each item of the score is rated on a five point scale where 1 equals completely disagree and 5 equals completely agree. The total score ranges from 5 to 20, with a higher score indicating a higher level of feasibility.
Measured: Day of hospital discharge of baby (about 48-72 hours after delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start19 Aug 2019
- Primary completion16 Sep 2019
- Study completion16 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Abstinence SyndromeStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of South Carolina
- Responsible party
- Principal investigator, Heather Jackson, Vanderbilt University Medical Center
- Investigators
- Heather Jackson, MSN, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973801
- Sponsor's protocol ID
- 191023
- Status last verified
- Mar 2020
- First submitted
- 3 Jun 2019
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Auricular Acupressure as an Adjunct Treatment for Neonatal Abstinence Syndrome (NAS)
- ClinicalTrials.gov ID
- NCT03973801
- Acronym / sponsor ID
- 191023
- Conditions
- Neonatal Abstinence Syndrome, Withdrawal
- Keywords
- Acupressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Medical University of South Carolina
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 16 Sep 2019 (actual)
- Study completion
- 16 Sep 2019 (actual)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Auricular acupressure | Experimental | Other: Auricular acupuncture |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Birth trauma
- Neonatal asphyxia
- Maternal or neonatal infection
- Congenital abnormalities
- Requiring Neonatal Intensive Care Unit (NICU) care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular acupunctureNational 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. | Other | Auricular acupressure |
Primary outcome
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 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)
Percent of missing medical record data
Time frame: hospital discharge (about 48-72 hours after delivery)
9 secondary outcomes
Percent of providers enrolled in 3 day training course for NADA protocol
Time frame: Prior to start of study enrollment (May 31, 2019)
Percent of providers completing 3 day training course for NADA protocol
Time frame: Day 3 of training
Percent of providers completing clinical competency with NADA protocol
Time frame: Prior to start of study enrollment (May 31, 2019)
Percent of providers receiving NADA certification
Time frame: Prior to start of study enrollment (May 31, 2019)
Percent of providers receiving credentialing
Time frame: Prior to start of study enrollment (May 31, 2019)
Client Satisfaction Questionnaire (CSQ*) Score
Time frame: Day of discharge (about 48-72 hours after delivery)
Intervention Appropriateness Measure (IAM) Score
Time frame: Day of hospital discharge of baby (about 48-72 hours after delivery)
Acceptability of Intervention Measure (AIM)
Time frame: Day of hospital discharge of baby (about 48-72 hours after delivery)
Feasibility of Intervention Measure (FIM)
Time frame: Day of hospital discharge of baby (about 48-72 hours after delivery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Neonatal Abstinence Syndrome
Active, not recruiting
Effective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk Pregnant Women
Neonatal Abstinence Syndrome, Opioid-use Disorder
Not yet recruiting
Recorded Parent/Caregiver Voice for Infants With Neonatal Opioid Withdrawal Syndrome
Neonatal Opioid Withdrawal Syndrome, Prenatal Opioid Exposure
Recruiting
Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome
NAS
Recruiting
An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)
Opioid Use Disorder, Neonatal Abstinence Syndrome
Active, not recruiting
Neurostimulation to Improve NOWS Outcomes
Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Jackson, MSN principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular acupuncture in people with Neonatal Abstinence Syndrome and Withdrawal, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of eligible patients enrolled (time frame: end of study enrollment (about 12 weeks)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.