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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