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Acupuncture in Neonatal Abstinence Syndrome (NAS) Babies (AA NAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02062151
Recruitment Status : Completed
First Posted : February 13, 2014
Results First Posted : January 16, 2019
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
University of South Florida

Tracking Information
First Submitted Date  ICMJE February 5, 2014
First Posted Date  ICMJE February 13, 2014
Results First Submitted Date  ICMJE August 11, 2016
Results First Posted Date  ICMJE January 16, 2019
Last Update Posted Date July 17, 2019
Study Start Date  ICMJE February 2014
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 10, 2014)
Utilizing auricular acupuncture as an adjunctive treatment in NAS infants requiring pharmacologic therapy will be feasible. [ Time Frame: 1 year ]
Change History Complete list of historical versions of study NCT02062151 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acupuncture in Neonatal Abstinence Syndrome (NAS) Babies
Official Title  ICMJE Acupuncture Use in Infants Treated for Neonatal Abstinence Syndrome: a Pilot Study
Brief 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. 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:

  1. Determine parent and staff acceptability of auricular acupuncture
  2. Determine infant tolerance to auricular acupuncture
  3. Evaluate the effect of auricular acupuncture on individual items of the Modified Finnegan Neonatal Abstinence Severity score associated with sympathetic nervous system responses
  4. Evaluate the effect of auricular acupuncture on time to return to birth weight
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Neonatal Abstinence Syndrome
Intervention  ICMJE Other: Acupuncture
Acupuncture
Study Arms  ICMJE Experimental: NAS babies
Acupuncture for NAS
Intervention: Other: Acupuncture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 23, 2018)
21
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2014)
40
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Gestational age ≥37.0 wks assessed by the obstetrical team from dating of last menstrual period, ultrasound, or best obstetric estimate
  2. Admitted to NICU with diagnosis of NAS requiring pharmacologic therapy
  3. Parents give written consent within 72 hours of infant receiving first dose of methadone

Exclusion Criteria:

  1. Helix or antihelix of ear is deformed and needle is unable to be placed
  2. A suspected or confirmed genetic or metabolic syndrome
  3. Custody retained by the Department of Children and Families
  4. Any skin condition involving the ear(s)
  5. Suspected or documented infection at the time of enrollment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 3 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02062151
Other Study ID Numbers  ICMJE Acupuncture for NAS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of South Florida
Study Sponsor  ICMJE University of South Florida
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Laura Weathers, MD University of South Florida
PRS Account University of South Florida
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP