Efficacy of Auricular Acupuncture on Neonatal Abstinence Syndrome
Completed · Not applicable
Conditions studied: Neonatal Abstinence Syndrome
In brief
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.
Key facts
- Study ID
- NCT02872077
- Run by
- University of South Florida
- People needed
- 26
- Starts
- 2016-08-01
- Expected to finish
- 2018-10-09
- Last updated by the study team
- 2019-07-16
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Gestational age ≥ 35 0/7 weeks assessed by the obstetrical team from dating of last menstrual period, ultrasound, or best obstetric estimate
- Admitted to the TGH Transition Nursery or NICU with a diagnosis of NAS, or maternal / infant positive urine drug screen result
- 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
- Parents give written consent prior to starting pharmacologic treatment for NAS
- AA needles are placed within 9 hours of infant's initial NICU Finnegan score >4
You may not qualify if…
- Helix or antihelix of ear is deformed and needle is unable to be placed
- Skin condition around the ear
- A suspected or confirmed genetic or metabolic syndrome
- Department of Children and Families investigation results in termination of parental rights
Where it is running
- USF Health — Tampa, Florida, United States
Full record on ClinicalTrials.gov
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