Feasibility of Auricular Acupressure as an Adjunct Treatment for Neonatal Abstinence Syndrome (NAS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Percent of eligible patients enrolled
研究概览
简要总结
This study will assess the feasibility of implementing auricular acupressure as an additional non-pharmacologic therapy for neonates at risk for developing neonatal abstinence syndrome (NAS) at Monroe Carrell Jr Children's Hospital at Vanderbilt University Medical Center (VUMC).
详细描述
NAS is a condition in which newborns experience withdrawal symptoms as a result of in utero exposure to opioids and/or other substances ingested by the mother. The condition has significantly risen over the past 20 years. First line treatments for NAS involve the maximization of non-pharmacologic therapies. NAS management focuses on reducing or eliminating the need for medication management to prevent further developmental complications, promote maternal bonding, and reduce hospital length of stay.
Auricular acupuncture has been used for the treatment of addiction and has demonstrated efficacy in the adult population. Current evidence suggests that acupuncture is safe and beneficial for multiple conditions that impact neonatal and pediatric populations including NAS. Acupressure is a less invasive therapy and may serve as an additional non-pharmacological adjunct to ease the severe discomfort of withdrawal in neonates at risk for NAS.
This study will assess the feasibility of implementing auricular acupressure as an additional non-pharmacologic therapy for neonates at risk for developing neonatal abstinence syndrome (NAS) at Monroe Carrell Jr Children's Hospital at Vanderbilt University Medical Center (VUMC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •37 weeks gestational age or greater
- •Maternal age 16 or older
- •Substance exposure in utero including opioids, illicit drugs, or other medications that cause neonatal withdrawal
排除标准
- •Birth trauma
- •Neonatal asphyxia
- •Maternal or neonatal infection
- •Congenital abnormalities
- •Requiring Neonatal Intensive Care Unit (NICU) care
结局指标
主要结局
Percent of eligible patients enrolled
时间窗: end of study enrollment (about 12 weeks)
Percent of patients prematurely terminating treatment
时间窗: hospital discharge (about 48-72 hours after delivery)
Percent of missing medical record data
时间窗: hospital discharge (about 48-72 hours after delivery)
Percent of participants completing all study assessments
时间窗: hospital discharge (about 48-72 hours after delivery)
Percent of data collection procedures completed
时间窗: hospital discharge (about 48-72 hours after delivery)
次要结局
- Client Satisfaction Questionnaire (CSQ*) Score(Day of discharge (about 48-72 hours after delivery))
- Percent of providers enrolled in 3 day training course for NADA protocol(Prior to start of study enrollment (May 31, 2019))
- Percent of providers receiving NADA certification(Prior to start of study enrollment (May 31, 2019))
- Percent of providers receiving credentialing(Prior to start of study enrollment (May 31, 2019))
- Intervention Appropriateness Measure (IAM) Score(Day of hospital discharge of baby (about 48-72 hours after delivery))
- Acceptability of Intervention Measure (AIM)(Day of hospital discharge of baby (about 48-72 hours after delivery))
- Feasibility of Intervention Measure (FIM)(Day of hospital discharge of baby (about 48-72 hours after delivery))
- Percent of providers completing 3 day training course for NADA protocol(Day 3 of training)
- Percent of providers completing clinical competency with NADA protocol(Prior to start of study enrollment (May 31, 2019))
研究者
Heather Jackson
Associate in Anesthesiology, Division of Pain Medicine
Vanderbilt University Medical Center