Clinical trial NCT02872077: Efficacy of Auricular Acupuncture on Neonatal Abstinence Syndrome
Official title: Efficacy of Auricular Acupuncture on Neonatal Abstinence Syndrome: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Abstinence Syndrome
Keywords: AA for NAS
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2016-08-18
Enrollment: 26
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The number of infants requiring / starting methadone
timeFrame: Up to 5 days
Secondary outcomes:
measure: cumulative total amount of methadone exposure
timeFrame: up to two months
measure: total length of hospital stay
timeFrame: duration of hospital stay
measure: peak single finnegan score after treatment initiation
timeFrame: within first two weeks
measure: Peak dose of methadone required after initial AA treatment
timeFrame: within the first two weeks
measure: average modified finnegan neonatal abstinence severity score for CNS symptoms
timeFrame: Up to two months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: USF Health
state: Florida
Study officials:
affiliation: USF Health Pediatrics / Neonatology
name: Maya Balakrishnan, MD
role: STUDY_DIRECTOR
References: