Efficacy of Auricular Acupuncture on Neonatal Abstinence Syndrome (AA NAS)
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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Florida
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Tampa、Florida、美国、33606
- USF Health
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Auricular Acupuncture
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.
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无干预：Control
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.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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The number of infants requiring / starting methadone
大体时间：Up to 5 days
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Up to 5 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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cumulative total amount of methadone exposure
大体时间：up to two months
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up to two months
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total length of hospital stay
大体时间：duration of hospital stay
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duration of hospital stay
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peak single finnegan score after treatment initiation
大体时间：within first two weeks
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within first two weeks
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Peak dose of methadone required after initial AA treatment
大体时间：within the first two weeks
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within the first two weeks
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average modified finnegan neonatal abstinence severity score for CNS symptoms
大体时间：Up to two months
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Up to two months
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合作者和调查者
调查人员
- 研究主任：Maya Balakrishnan, MD、USF Health Pediatrics / Neonatology
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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