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Trial record 65 of 1204 for:    acupuncture

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

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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

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.

Condition or disease Intervention/treatment Phase
Neonatal Abstinence Syndrome Other: Acupuncture Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Acupuncture Use in Infants Treated for Neonatal Abstinence Syndrome: a Pilot Study
Study Start Date : February 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: NAS babies
Acupuncture for NAS
Other: Acupuncture
Acupuncture




Primary Outcome Measures :
  1. Number of Participants With Skin Breakdown and / or Cellulitis [ Time Frame: up to 57 days ]
  2. Percentage of Dislodged Needles [ Time Frame: Within three days of placement ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02062151


Locations
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United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
Sponsors and Collaborators
University of South Florida
Investigators
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Principal Investigator: Laura Weathers, MD University of South Florida

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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT02062151     History of Changes
Other Study ID Numbers: Acupuncture for NAS
First Posted: February 13, 2014    Key Record Dates
Results First Posted: January 16, 2019
Last Update Posted: July 17, 2019
Last Verified: July 2019
Keywords provided by University of South Florida:
Acupuncture
Additional relevant MeSH terms:
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Neonatal Abstinence Syndrome
Syndrome
Disease
Pathologic Processes
Infant, Newborn, Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders