Neonatal Abstinence Syndrome Clinical Trial
Official title:
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01965704 -
Can Ondansetron Prevent Neonatal Abstinence Syndrome (NAS) in Babies Born to Narcotic-dependent Women
|
Phase 2 | |
| Completed |
NCT03890562 -
Assessing the Effects of Auricular Acupressure on Newborns With NAS
|
N/A | |
| Completed |
NCT01958476 -
Improving Outcomes in Neonatal Abstinence Syndrome
|
Phase 3 | |
| Active, not recruiting |
NCT01734551 -
NAS Treatment - Opiate Versus Non-Opiate
|
Phase 4 | |
| Completed |
NCT00496951 -
Vagal Tone and Neonatal Abstinence Syndrome
|
N/A | |
| Completed |
NCT02851303 -
Morphine Versus Methadone for Opiate Exposed Infants With Neonatal Abstinence Syndrome
|
Phase 4 | |
| Recruiting |
NCT05226624 -
The Alberta Neonatal Abstinence Syndrome Mother-Baby Care ImprovEmeNT Program
|
N/A | |
| Completed |
NCT03670160 -
Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome
|
Phase 2 | |
| Not yet recruiting |
NCT04611659 -
Averting NAS Among Opioid-Using Young Women Receiving MAT Using Buprenorphine
|
N/A | |
| Completed |
NCT01452789 -
Blinded Trial of Buprenorphine or Morphine in the Treatment of the Neonatal Abstinence Syndrome
|
Phase 3 | |
| Completed |
NCT04588519 -
tAN to Mitigate Withdrawal Behaviors in Neonates
|
N/A | |
| Completed |
NCT02797990 -
Conflict Between Maternal Autonomy and Child Health in Substance-use
|
N/A | |
| Completed |
NCT02801331 -
Efficacy and Outcomes of a Non-Pharmacological Intervention for Neonatal Abstinence Syndrome
|
N/A | |
| Terminated |
NCT03246243 -
Quantitative Assessment of Sucking for Early Diagnosis of Brain Injury in Infants at High Risk
|
||
| Completed |
NCT03567603 -
Sound Processing Changes in Babies With Opioid Exposure
|
||
| Recruiting |
NCT06303986 -
Study to Collect Data for Neonatal Abstinence Syndrome (NAS) and Evaluate the Automated Data Collection Process
|
||
| Active, not recruiting |
NCT03725332 -
The PATH Home Trial: A Comparative Effectiveness Study of Peripartum Opioid Use Disorder in Rural Kentucky
|
N/A | |
| Recruiting |
NCT04983563 -
Actigraphy and Neonatal Abstinence Syndrome of Hospitalized Newborn in Intensive Care Units
|
N/A | |
| Completed |
NCT04298853 -
Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome
|
Phase 4 | |
| Completed |
NCT02182973 -
Donor Human Milk in Neonatal Abstinence Syndrome
|