Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auricular acupuncture | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of infants requiring / starting methadone | Up to 5 days |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Maya Balakrishnan, MD | USF Health Pediatrics / Neonatology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USF Health | Tampa | Florida | 33606 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009357 | Neonatal Abstinence Syndrome |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D020831 | Acupuncture, Ear |
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D055097 | Auriculotherapy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| D001523 | Mental Disorders |