Clinical Trial: The Effect of Aromatherapy on Neonatal Abstinence Syndrome and Salivary Cortisol Levels
Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional
Official Title: The Effect of Aromatherapy on Neonatal Abstinence Syndrome and Salivary Cortisol Levels
Brief Summary: Determine the effectiveness of lavender and chamomile aromatherapy of mitigation of symptoms of Neonatal Abstinence Syndrome
Detailed Summary:
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 algorit
Sponsor: John M. Daniel
Current Primary Outcome: Length of Hospitalization [ Time Frame: Up to 4 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Length of medication therapy [ Time Frame: Up to 4 months ]
Original Secondary Outcome: Same as current
Information By: University of Kentucky
Dates:
Date Received: March 15, 2017
Date Started: July 25, 2015
Date Completion: July 25, 2017
Last Updated: March 30, 2017
Last Verified: March 2017
