Acupuncture Use in Infants Treated for Neonatal Abstinence Syndrome: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Number of Participants With Skin Breakdown and / or Cellulitis
研究概览
简要总结
This pilot study is intended to assess feasibility of auricular acupuncture in NAS infants who require pharmacologic therapy. We intend to evaluate acceptability of auricular acupuncture, infant tolerance, recruitment strategies, and methodological issues. We plan to also test and generate hypotheses in preparation to apply for funding a larger randomized controlled trial.
详细描述
Objectives:
Primary: To establish feasibility of a protocol for auricular acupuncture in infants suffering from NAS admitted to the NICU receiving pharmacologic therapy.
Secondary: In infants suffering from NAS admitted to the Neonatal Intensive Care Unit (NICU) receiving pharmacologic therapy:
- Determine parent and staff acceptability of auricular acupuncture
- Determine infant tolerance to auricular acupuncture
- Evaluate the effect of auricular acupuncture on individual items of the Modified Finnegan Neonatal Abstinence Severity score associated with sympathetic nervous system responses
- Evaluate the effect of auricular acupuncture on time to return to birth weight
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age ≥37.0 wks assessed by the obstetrical team from dating of last menstrual period, ultrasound, or best obstetric estimate
- •Admitted to NICU with diagnosis of NAS requiring pharmacologic therapy
- •Parents give written consent within 72 hours of infant receiving first dose of methadone
排除标准
- •Helix or antihelix of ear is deformed and needle is unable to be placed
- •A suspected or confirmed genetic or metabolic syndrome
- •Custody retained by the Department of Children and Families
- •Any skin condition involving the ear(s)
- •Suspected or documented infection at the time of enrollment
研究组 & 干预措施
NAS babies
Acupuncture for NAS
干预措施: Acupuncture (Other)
结局指标
主要结局
Number of Participants With Skin Breakdown and / or Cellulitis
时间窗: up to 57 days
Percentage of Dislodged Needles
时间窗: Within three days of placement
次要结局
未报告次要终点