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临床试验/NCT03097484
NCT03097484已完成3 期

The Effect of Aromatherapy on Neonatal Abstinence Syndrome and Salivary Cortisol Levels

John M. Daniel1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2015年7月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
38
试验地点
1
主要终点
Length of Hospitalization

研究概览

简要总结

Determine the effectiveness of lavender and chamomile aromatherapy of mitigation of symptoms of Neonatal Abstinence Syndrome

详细描述

The United States, Appalachia, Eastern Kentucky in particular, is in the midst of a major opioid abuse epidemic. This current epidemic is driven by misuse of prescription painkillers, i.e. Subutex and Saboxone. As prescription pills become more expensive and harder to acquire, addicts are seeking similar, cheaper drugs; such as heroin. From 1998 to 2011, the prevalence of opioid abuse and dependence amongst pregnant women has increased by 127%, from 1.7 per 1000 to 3.9 per 1000. Neonatal Abstinence Syndrome (NAS) or neonatal opioid withdrawal syndrome is a condition produces gastrointestinal and autonomic neurologic dysfunction. Infants with severe withdrawal experience dysregulation of autonomic functions, resulting in feeding difficulty, diarrhea, excessive sleepiness, and tremors.Nearly two thirds of all babies exposed to opioids during gestation will require admission to a neonatal intensive care unit for management of withdrawal symptoms. During a typical year the Neonatal Intensive Care Unit (NICU) at Kentucky Children's Hospital admits approximately 100-120 infants exhibiting NAS symptoms; these infants have a typical length of stay of 24 days if they require pharmacologic treatment.

The mainstay of treatment for NAS involves opioid replacement therapy with morphine to minimize withdrawal symptoms. Once symptoms are well controlled, the infant is said to have been "captured." At this point a slow weaning of his morphine dose occurs. The infants' clinical status is assessed with the Finnegan Scoring system, which examines symptoms such as crying, excessive sleepiness or difficulty sleeping, insomnia, or tremors along with objective findings such as temperature and respiratory rate.

In addition to pharmacotherapy, alternative and complementary medicine techniques are slowly entering the NAS treatment algorithm. Treatments such as music therapy infant massage, kangaroo care, aromatherapy, and acupressure are now employed in NICUs in addition to traditional opioids replacement. However, few studies exist in the literature to evaluate their effectiveness.

Aromatherapy is the practice of using natural essential oils to achieve a desired effect in an individual. Scents such as lavender and chamomile have been documented to have a soothing calming effect. Studies involving infants shown that lavender not only reduce crying and enhance sleep, but also reduce levels of salivary cortisol, a stress hormone. Additionally, aromatherapy is currently used as an adjunctive therapy at the University of Kentucky's Markey Cancer Center.

Salivary cortisol is a non-invasive biomarker that has proven useful for monitoring stress in neonates. It is a simple and painless method for monitoring the stress hormone cortisol. Salivary cortisol has been used successfully in infants as a method to assess infant stress associated with prone position versus supine positioning.These studies have shown that salivary cortisol levels vary with stressful or soothing stimuli.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 2 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Infants greater than or equal to 36 weeks EGA
  • Intrauterine opioid exposure
  • Primary diagnosis of NAS
  • Parental permission to participate

排除标准

  • Infants less than 36 weeks EGA
  • Major congenital anomalies
  • Latrogenic drug withdrawal
  • Diagnosis of infection or respiratory distress
  • Prior initiation of opioid replacement therapy
  • Non-English speaking
  • Infants with respiratory conditions

研究组 & 干预措施

Standard therapy plus Aromatherapy

Experimental

These infants will receive aromatherapy, consisting of Lavender and Chamomile essential oils, in addition to standard care, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy.

干预措施: lavender and chamomile essential oils (Drug)

结局指标

主要结局

Length of Hospitalization

时间窗: Up to 4 months

How long the infant remains hospitalized.

次要结局

  • Length of Medication Therapy(Up to 4 months)

研究者

发起方
John M. Daniel
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

John M. Daniel

Fellow, Department of Pediatrics, Division of Neonatology

University of Kentucky

研究点 (1)

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