Efficacy of Auricular Acupuncture on Neonatal Abstinence Syndrome (AA NAS)

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

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.

Study Overview

• Status: Completed
• Conditions: Neonatal Abstinence Syndrome
• Intervention / Treatment: Other: Auricular acupuncture

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • USF Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Gestational age ≥ 35 0/7 weeks assessed by the obstetrical team from dating of last menstrual period, ultrasound, or best obstetric estimate
2. Admitted to the TGH Transition Nursery or NICU with a diagnosis of NAS, or maternal / infant positive urine drug screen result
3. 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
4. Parents give written consent prior to starting pharmacologic treatment for NAS
5. AA needles are placed within 9 hours of infant's initial NICU Finnegan score >4

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Auricular Acupuncture; Study subjects randomized to this group will receive auricular acupuncture: the investigator will evaluate the infant using an ear point locator to determine active sites, and will place acupuncture needles in the active sites found in one ear. Acupuncture sites will be alternated every 3 days between right and left ear.	Other: Auricular acupuncture
No Intervention: Control; The subjects randomized to the control group will have NO interventions, and will continue to receive routine care for NAS, pharmacologic and non-pharmacologic, per NICU protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of infants requiring / starting methadone	Up to 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cumulative total amount of methadone exposure		up to two months
total length of hospital stay		duration of hospital stay
peak single finnegan score after treatment initiation		within first two weeks
Peak dose of methadone required after initial AA treatment		within the first two weeks
average modified finnegan neonatal abstinence severity score for CNS symptoms	Excessive cry; Sleep <3 hours after feeding; Hyperactive reflexes; Tremors; Increased muscle tone; Excoriation; Myoclonic jerks; Generalized convulsions	Up to two months

Collaborators and Investigators

• Sponsor: University of South Florida
• Investigators: Study Director: Maya Balakrishnan, MD, USF Health Pediatrics / Neonatology

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): October 9, 2018
• Study Completion (Actual): October 9, 2018

Study Registration Dates

• First Submitted: August 15, 2016
• First Submitted That Met QC Criteria: August 17, 2016
• First Posted (Estimate): August 18, 2016

Study Record Updates

• Last Update Posted (Actual): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 15, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: AA for NAS
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Disease; Infant, Newborn, Diseases; Syndrome; Neonatal Abstinence Syndrome
• Other Study ID Numbers: IRB#Pro00025881

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO