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OpenTrials
Completed

NCT Number: NCT02872077

Efficacy of Auricular Acupuncture on Neonatal Abstinence Syndrome

This study will assess the efficacy of needle auricular acupuncture (AA) in neonatal abstinence syndrome (NAS) infants who require pharmacologic therapy at the Tampa General Hospital NICU. The investigators will evaluate efficacy of needle AA as an adjunct treatment for NAS by means of total methadone dose exposure, peak withdrawal scores, and overall length of stay.

This is the first study to evaluate efficacy of needle AA as an adjunct treatment for NAS by means of total methadone dose exposure, peak withdrawal scores, and overall length of stay.

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Key information

Age range

Up to 5 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USF Health

Tampa, Florida, 33606, United States

About this study

Enrolled infants will be randomized to a control group and an acupuncture group.

The control group will receive nonpharmacologic and pharmacologic management as per our current standard of care.

The acupuncture group will additionally receive AA. Once the infant is enrolled, he/she will be randomized to the AA group or the control group. Both groups of randomized infants will be taken daily to a designated treatment room. Infants in the control group will not receive acupuncture, and will only receive observation in the treatment room and will have review of their EMR.

If in the AA group, the investigator will evaluate the infant using an ear point locator to determine active sites prior to each needle placement. Acupuncture infants will have needles placed in any active sites found in one ear (up to 5 needles). Acupuncture sites will be alternated daily between right and left ear.

Acupuncture will be discontinued on the same day as methadone is discontinued, or if infant is cleared to be discharged home on methadone, acupuncture is discontinued when infant reaches the discharge dose of methadone.

Data for both groups will be collected on the day of enrollment, every three days during study participation, and at hospital discharge.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Gestational age ≥ 35 0/7 weeks assessed by the obstetrical team from dating of last menstrual period, ultrasound, or best obstetric estimate
  • Admitted to the TGH Transition Nursery or NICU with a diagnosis of NAS, or maternal / infant positive urine drug screen result
  • May have any of the following additional diagnoses at the time of admission: late prematurity, hyperbilirubinemia, hypoglycemia, sepsis without hypotension, respiratory distress without requiring support, or temperature instability
  • Parents give written consent prior to starting pharmacologic treatment for NAS
  • AA needles are placed within 9 hours of infant's initial NICU Finnegan score >4

Exclusion criteria

  • Helix or antihelix of ear is deformed and needle is unable to be placed
  • Skin condition around the ear
  • A suspected or confirmed genetic or metabolic syndrome
  • Department of Children and Families investigation results in termination of parental rights

Treatment and study plan

Auricular Acupuncture

Other

Primary outcomes

  1. The number of infants requiring / starting methadone

    Time frame: Up to 5 days

Secondary outcomes

  1. cumulative total amount of methadone exposure

    Time frame: up to two months

  2. total length of hospital stay

    Time frame: duration of hospital stay

  3. peak single finnegan score after treatment initiation

    Time frame: within first two weeks

  4. Peak dose of methadone required after initial AA treatment

    Time frame: within the first two weeks

  5. average modified finnegan neonatal abstinence severity score for CNS symptoms

    Time frame: Up to two months

    • Excessive cry
    • Sleep <3 hours after feeding
    • Hyperactive reflexes
    • Tremors
    • Increased muscle tone
    • Excoriation
    • Myoclonic jerks
    • Generalized convulsions

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Official study title

Efficacy of Auricular Acupuncture on Neonatal Abstinence Syndrome: A Randomized Controlled Trial

Acronym: AA NAS

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 18, 2016
Registry last updated
Jul 16, 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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