Efficacy of Auricular Acupuncture on Neonatal Abstinence Syndrome

NCT02872077 | Completed

• 1 other identifier: IRB#Pro00025881
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neonatal Abstinence Syndrome

Keywords

AA for NAS

Outcome Measures

Primary Outcomes (1)

• The number of infants requiring / starting methadone

  Up to 5 days

Secondary Outcomes (5)

• 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

  Up to two months

Study Arms (2)

Auricular Acupuncture

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

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.

Interventions

Auricular acupuncture OTHER

Auricular Acupuncture

Eligibility Criteria

• Age: Up to 5 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

USF Health

Tampa, Florida, 33606, United States

Location

MeSH Terms

Conditions

Neonatal Abstinence Syndrome

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Study Officials

• Maya Balakrishnan, MD

  USF Health Pediatrics / Neonatology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2016
• First Posted: August 18, 2016
• Study Start: August 1, 2016
• Primary Completion: October 9, 2018
• Study Completion: October 9, 2018
• Last Updated: July 16, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)