Neonatal Abstinence SyndromeAA NASNCT02872077
Efficacy of Auricular Acupuncture on Neonatal Abstinence Syndrome
A study testing Auricular acupuncture in people with Neonatal Abstinence Syndrome, run by University of South Florida at 1 site in United States.
Trial summary
This study will assess the efficacy of needle auricular acupuncture (AA) in neonatal abstinence syndrome (NAS) infants who require pharmacologic therapy at the Tampa General Hospital NICU. Read more about this study
- Who is it for?
- Ages Up to 5 days
- Conditions the study is for
- Neonatal Abstinence Syndrome
- What is being tested?
- Auricular acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 9 Oct 2018
- 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 5 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age ≥ 35 0/7 weeks assessed by the obstetrical team from dating of last menstrual period, ultrasound, or best obstetric estimate
- Admitted to the TGH Transition Nursery or NICU with a diagnosis of NAS, or maternal / infant positive urine drug screen result
- May have any of the following additional diagnoses at the time of admission: late prematurity, hyperbilirubinemia, hypoglycemia, sepsis without hypotension, respiratory distress without requiring support, or temperature instability
- Parents give written consent prior to starting pharmacologic treatment for NAS
- AA needles are placed within 9 hours of infant's initial NICU Finnegan score >4
Who cannot join
- Helix or antihelix of ear is deformed and needle is unable to be placed
- Skin condition around the ear
- A suspected or confirmed genetic or metabolic syndrome
- Department of Children and Families investigation results in termination of parental rights
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Auricular Acupuncture on Neonatal Abstinence Syndrome: A Randomized Controlled Trial
This study will assess the efficacy of needle auricular acupuncture (AA) in neonatal abstinence syndrome (NAS) infants who require pharmacologic therapy at the Tampa General Hospital NICU. The investigators will evaluate efficacy of needle AA as an adjunct treatment for NAS by means of total methadone dose exposure, peak withdrawal scores, and overall length of stay.
This is the first study to evaluate efficacy of needle AA as an adjunct treatment for NAS by means of total methadone dose exposure, peak withdrawal scores, and overall length of stay.
Read the detailed description
Enrolled infants will be randomized to a control group and an acupuncture group.
The control group will receive nonpharmacologic and pharmacologic management as per our current standard of care.
The acupuncture group will additionally receive AA. Once the infant is enrolled, he/she will be randomized to the AA group or the control group. Both groups of randomized infants will be taken daily to a designated treatment room. Infants in the control group will not receive acupuncture, and will only receive observation in the treatment room and will have review of their EMR.
If in the AA group, the investigator will evaluate the infant using an ear point locator to determine active sites prior to each needle placement. Acupuncture infants will have needles placed in any active sites found in one ear (up to 5 needles). Acupuncture sites will be alternated daily between right and left ear.
Acupuncture will be discontinued on the same day as methadone is discontinued, or if infant is cleared to be discharged home on methadone, acupuncture is discontinued when infant reaches the discharge dose of methadone.
Data for both groups will be collected on the day of enrollment, every three days during study participation, and at hospital discharge.
- Conditions
- Neonatal Abstinence Syndrome
- Being tested
- Auricular acupuncture
- Keywords
- AA for NAS
- 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
| Study group | Role | What they receive |
|---|---|---|
| Auricular Acupuncture | Active comparator | Study subjects randomized to this group will receive auricular acupuncture: the investigator will evaluate the infant using an ear point locator to determine active sites, and will place acupuncture needles in the active sites found in one ear. Acupuncture sites will be alternated every 3 days between right and left ear. Receives: Other: Auricular acupuncture |
| Control | No intervention | The subjects randomized to the control group will have NO interventions, and will continue to receive routine care for NAS, pharmacologic and non-pharmacologic, per NICU protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of infants requiring / starting methadone
Measured: Up to 5 days
Secondary outcomes (5)
cumulative total amount of methadone exposure
Measured: up to two months
total length of hospital stay
Measured: duration of hospital stay
peak single finnegan score after treatment initiation
Measured: within first two weeks
Peak dose of methadone required after initial AA treatment
Measured: within the first two weeks
average modified finnegan neonatal abstinence severity score for CNS symptoms
- Excessive cry
- Sleep <3 hours after feeding
- Hyperactive reflexes
- Tremors
- Increased muscle tone
- Excoriation
- Myoclonic jerks
- Generalized convulsions
Measured: Up to two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startAug 2016
- Primary completion9 Oct 2018
- Study completion9 Oct 2018
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 University of South FloridaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maya Balakrishnan, MD, Study director, USF Health Pediatrics / Neonatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872077
- Sponsor's protocol ID
- IRB#Pro00025881
- Acronym
- AA NAS
- Status last verified
- Jul 2019
- First submitted
- 15 Aug 2016
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Auricular Acupuncture on Neonatal Abstinence Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02872077
- Acronym / sponsor ID
- AA NAS / IRB#Pro00025881
- Conditions
- Neonatal Abstinence Syndrome
- Keywords
- AA for NAS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- 9 Oct 2018 (actual)
- Study completion
- 9 Oct 2018 (actual)
- First posted
- 18 Aug 2016 (estimated)
- 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 efficacy of needle auricular acupuncture (AA) in neonatal abstinence syndrome (NAS) infants who require pharmacologic therapy at the Tampa General Hospital NICU. The investigators will evaluate efficacy of needle AA as an adjunct treatment for NAS by means of total methadone dose exposure, peak withdrawal scores, and overall length of stay.
This is the first study to evaluate efficacy of needle AA as an adjunct treatment for NAS by means of total methadone dose exposure, peak withdrawal scores, and overall length of stay.
Detailed description
Enrolled infants will be randomized to a control group and an acupuncture group.
The control group will receive nonpharmacologic and pharmacologic management as per our current standard of care.
The acupuncture group will additionally receive AA. Once the infant is enrolled, he/she will be randomized to the AA group or the control group. Both groups of randomized infants will be taken daily to a designated treatment room. Infants in the control group will not receive acupuncture, and will only receive observation in the treatment room and will have review of their EMR.
If in the AA group, the investigator will evaluate the infant using an ear point locator to determine active sites prior to each needle placement. Acupuncture infants will have needles placed in any active sites found in one ear (up to 5 needles). Acupuncture sites will be alternated daily between right and left ear.
Acupuncture will be discontinued on the same day as methadone is discontinued, or if infant is cleared to be discharged home on methadone, acupuncture is discontinued when infant reaches the discharge dose of methadone.
Data for both groups will be collected on the day of enrollment, every three days during study participation, and at hospital discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular Acupuncture | Active comparator | Other: Auricular acupunctureStudy subjects randomized to this group will receive auricular acupuncture: the investigator will evaluate the infant using an ear point locator to determine active sites, and will place acupuncture needles in the active sites found in one ear. Acupuncture sites will be alternated every 3 days between right and left ear. |
| Control | No intervention | –The subjects randomized to the control group will have NO interventions, and will continue to receive routine care for NAS, pharmacologic and non-pharmacologic, per NICU protocol. |
Who may qualify
- Ages
- Up to 5 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Gestational age ≥ 35 0/7 weeks assessed by the obstetrical team from dating of last menstrual period, ultrasound, or best obstetric estimate
- Admitted to the TGH Transition Nursery or NICU with a diagnosis of NAS, or maternal / infant positive urine drug screen result
- May have any of the following additional diagnoses at the time of admission: late prematurity, hyperbilirubinemia, hypoglycemia, sepsis without hypotension, respiratory distress without requiring support, or temperature instability
- Parents give written consent prior to starting pharmacologic treatment for NAS
- AA needles are placed within 9 hours of infant's initial NICU Finnegan score >4
Key exclusion criteria (4 listed)
- Helix or antihelix of ear is deformed and needle is unable to be placed
- Skin condition around the ear
- A suspected or confirmed genetic or metabolic syndrome
- Department of Children and Families investigation results in termination of parental rights
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 acupuncture | Other | Auricular Acupuncture |
Primary outcome
The number of infants requiring / starting methadone
Time frame: Up to 5 days
5 secondary outcomes
cumulative total amount of methadone exposure
Time frame: up to two months
total length of hospital stay
Time frame: duration of hospital stay
peak single finnegan score after treatment initiation
Time frame: within first two weeks
Peak dose of methadone required after initial AA treatment
Time frame: within the first two weeks
average modified finnegan neonatal abstinence severity score for CNS symptoms
Time frame: Up to two months
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 16 Jul 2019.
- 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.
Maya Balakrishnan, MD study director
USF Health Pediatrics / Neonatology
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, run by University of South Florida 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 5 inclusion and 4 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 16 Jul 2019. 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?
The number of infants requiring / starting methadone (time frame: Up to 5 days). 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 16 Jul 2019.