NCT02872077

Efficacy of Auricular Acupuncture on Neonatal Abstinence Syndrome

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 5 Days
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Neonatal Abstinence Syndrome

Interventions

Type	Name	Description
OTHER	Auricular acupuncture

Timeline

• Start date: 2016-08-01
• Primary completion: 2018-10-09
• Completion: 2018-10-09
• First posted: 2016-08-18
• Last updated: 2019-07-16

Locations

1 site across 1 country: United States