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Completed

NCT Number: NCT02062151

Acupuncture in Neonatal Abstinence Syndrome (NAS) Babies

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.

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Key information

Conditions

Neonatal Abstinence Syndrome Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Mental Disorders Substance-Related Disorders

Age range

1 day–3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tampa General Hospital

Tampa, Florida, 33606, United States

About this study

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:

  • Determine parent and staff acceptability of auricular acupuncture
  • Determine infant tolerance to auricular acupuncture
  • Evaluate the effect of auricular acupuncture on individual items of the Modified Finnegan Neonatal Abstinence Severity score associated with sympathetic nervous system responses
  • Evaluate the effect of auricular acupuncture on time to return to birth weight

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Helix or antihelix of ear is deformed and needle is unable to be placed
  • A suspected or confirmed genetic or metabolic syndrome
  • Custody retained by the Department of Children and Families
  • Any skin condition involving the ear(s)
  • Suspected or documented infection at the time of enrollment

Treatment and study plan

Acupuncture

Other

Acupuncture

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Official study title

Acupuncture Use in Infants Treated for Neonatal Abstinence Syndrome: a Pilot Study

Acronym: AA NAS

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 13, 2014
Registry last updated
Jul 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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