Efficacy of Auricular Acupuncture on Neonatal Abstinence Syndrome

Neonatal Abstinence Syndrome Clinical Trial

— AA NAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02872077
• Other study ID #: IRB#Pro00025881
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: October 9, 2018

Study information

• Verified date: July 2019
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 9, 2018
• Est. primary completion date: October 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Days

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Abstinence Syndrome
• Syndrome

Intervention

Other:
• Auricular acupuncture

Locations

Country	Name	City	State
United States	USF Health	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of infants requiring / starting methadone		Up to 5 days
Secondary	cumulative total amount of methadone exposure		up to two months
Secondary	total length of hospital stay		duration of hospital stay
Secondary	peak single finnegan score after treatment initiation		within first two weeks
Secondary	Peak dose of methadone required after initial AA treatment		within the first two weeks
Secondary	average modified finnegan neonatal abstinence severity score for CNS symptoms	Excessive cry; Sleep <3 hours after feeding; Hyperactive reflexes; Tremors; Increased muscle tone; Excoriation; Myoclonic jerks; Generalized convulsions	Up to two months