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

University of South Florida

Status: Completed

Conditions: Neonatal Abstinence Syndrome

Treatments: Other: Auricular acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02872077

IRB#Pro00025881

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: Under 5 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

Auricular Acupuncture

Active Comparator group

Description:

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.

Treatment:

Other: Auricular acupuncture

Control

No Intervention group

Description:

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.