Acupuncture in Neonatal Abstinence Syndrome (NAS) Babies

N/ACompletedNCT02062151

University of South Florida21 enrolled

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.

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

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Neonatal Abstinence Syndrome

Interventions

AcupunctureOTHER

Acupuncture

Eligibility

Sex: ALLMin age: 1 DayMax age: 3 Months

Medical Language ↔ Plain English

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

Locations (1)

Tampa General Hospital

Tampa, Florida, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.