Acupuncture in Neonatal Abstinence Syndrome (NAS) Babies

Overview

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.

Full Title of Study: “Acupuncture Use in Infants Treated for Neonatal Abstinence Syndrome: a Pilot Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2015

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

Interventions

  • Other: Acupuncture
    • Acupuncture

Arms, Groups and Cohorts

  • Experimental: NAS babies
    • Acupuncture for NAS

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 1 Day

Maximum Age: 3 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of South Florida
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Laura Weathers, MD, Principal Investigator, University of South Florida

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