Neonatal Abstinence SyndromeAA NASNCT02062151
Acupuncture in Neonatal Abstinence Syndrome (NAS) Babies
A study testing Acupuncture in people with Neonatal Abstinence Syndrome, run by University of South Florida at 1 site in United States.
Trial summary
This pilot study is intended to assess feasibility of auricular acupuncture in NAS infants who require pharmacologic therapy. We intend to evaluate acceptability of auricular acupuncture, infant tolerance, recruitment strategies, and methodological issues. Read more about this study
- Who is it for?
- Ages 1 day to 3 months
- Conditions the study is for
- Neonatal Abstinence Syndrome
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 day to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age ≥37.0 wks assessed by the obstetrical team from dating of last menstrual period, ultrasound, or best obstetric estimate
- Admitted to NICU with diagnosis of NAS requiring pharmacologic therapy
- Parents give written consent within 72 hours of infant receiving first dose of methadone
Who cannot join
- Helix or antihelix of ear is deformed and needle is unable to be placed
- A suspected or confirmed genetic or metabolic syndrome
- Custody retained by the Department of Children and Families
- Any skin condition involving the ear(s)
- Suspected or documented infection at the time of enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acupuncture Use in Infants Treated for Neonatal Abstinence Syndrome: a Pilot Study
This pilot study is intended to assess feasibility of auricular acupuncture in NAS infants who require pharmacologic therapy. We intend to evaluate acceptability of auricular acupuncture, infant tolerance, recruitment strategies, and methodological issues. We plan to also test and generate hypotheses in preparation to apply for funding a larger randomized controlled trial.
Read the detailed description
Objectives:
Primary: To establish feasibility of a protocol for auricular acupuncture in infants suffering from NAS admitted to the NICU receiving pharmacologic therapy.
Secondary: In infants suffering from NAS admitted to the Neonatal Intensive Care Unit (NICU) receiving pharmacologic therapy:
- Determine parent and staff acceptability of auricular acupuncture
- Determine infant tolerance to auricular acupuncture
- Evaluate the effect of auricular acupuncture on individual items of the Modified Finnegan Neonatal Abstinence Severity score associated with sympathetic nervous system responses
- Evaluate the effect of auricular acupuncture on time to return to birth weight
- Conditions
- Neonatal Abstinence Syndrome
- Being tested
- Acupuncture
- Keywords
- Acupuncture
- 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.
AcupunctureOther
Acupuncture
| Study group | Role | What they receive |
|---|---|---|
| NAS babies | Experimental | Acupuncture for NAS Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Skin Breakdown and / or Cellulitis
Measured: up to 57 days
Percentage of Dislodged Needles
Measured: Within three days of placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Weathers, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062151
- Sponsor's protocol ID
- Acupuncture for NAS
- Acronym
- AA NAS
- Status last verified
- Jul 2019
- First submitted
- 5 Feb 2014
- Last updated
- 17 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Use in Infants Treated for Neonatal Abstinence Syndrome: a Pilot Study
- ClinicalTrials.gov ID
- NCT02062151
- Acronym / sponsor ID
- AA NAS / Acupuncture for NAS
- Conditions
- Neonatal Abstinence Syndrome
- Keywords
- Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 13 Feb 2014 (estimated)
- Results
- Posted 16 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study is intended to assess feasibility of auricular acupuncture in NAS infants who require pharmacologic therapy. We intend to evaluate acceptability of auricular acupuncture, infant tolerance, recruitment strategies, and methodological issues. We plan to also test and generate hypotheses in preparation to apply for funding a larger randomized controlled trial.
Detailed description
Objectives:
Primary: To establish feasibility of a protocol for auricular acupuncture in infants suffering from NAS admitted to the NICU receiving pharmacologic therapy.
Secondary: In infants suffering from NAS admitted to the Neonatal Intensive Care Unit (NICU) receiving pharmacologic therapy:
- Determine parent and staff acceptability of auricular acupuncture
- Determine infant tolerance to auricular acupuncture
- Evaluate the effect of auricular acupuncture on individual items of the Modified Finnegan Neonatal Abstinence Severity score associated with sympathetic nervous system responses
- Evaluate the effect of auricular acupuncture on time to return to birth weight
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NAS babies | Experimental | Other: AcupunctureAcupuncture for NAS |
Who may qualify
- Ages
- 1 day to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Gestational age ≥37.0 wks assessed by the obstetrical team from dating of last menstrual period, ultrasound, or best obstetric estimate
- Admitted to NICU with diagnosis of NAS requiring pharmacologic therapy
- Parents give written consent within 72 hours of infant receiving first dose of methadone
Key exclusion criteria (5 listed)
- Helix or antihelix of ear is deformed and needle is unable to be placed
- A suspected or confirmed genetic or metabolic syndrome
- Custody retained by the Department of Children and Families
- Any skin condition involving the ear(s)
- Suspected or documented infection at the time of enrollment
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 |
|---|---|---|
| AcupunctureAcupuncture | Other | NAS babies |
Primary outcome
Number of Participants With Skin Breakdown and / or Cellulitis
Time frame: up to 57 days
Percentage of Dislodged Needles
Time frame: Within three days of placement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)
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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.
Laura Weathers, MD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 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 17 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?
Yes. Results are posted in the registry (first posted 16 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Skin Breakdown and / or Cellulitis (time frame: up to 57 days). The study lists 2 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 17 Jul 2019.