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

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ClinicalTrials.gov Identifier: NCT03097484
Recruitment Status : Completed
First Posted : March 31, 2017
Results First Posted : May 14, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
John M. Daniel, University of Kentucky

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

Condition or disease Intervention/treatment Phase
Neonatal Abstinence Syndrome Aromatherapy Drug: lavender and chamomile essential oils Phase 3

Detailed Description:

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.

To date, no dangerous or deleterious effects have been described from traditional inhalational use of aromatherapy or with salivary cortisol sampling. Studies have shown aromatherapy to be an effective adjunctive therapy by proving a calming effect. In our patient population it may prove to be a useful complimentary therapy ultimately reducing infant stress, hospital length of stay, and burden of opioid use. Additionally, salivary cortisol's ease of collection and non-invasive nature make it an ideal biomarker to study.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Aromatherapy on Neonatal Abstinence Syndrome and Salivary Cortisol Levels
Actual Study Start Date : July 25, 2015
Actual Primary Completion Date : April 30, 2017
Actual Study Completion Date : April 30, 2017


Arm Intervention/treatment
Experimental: Standard therapy plus Aromatherapy
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.
Drug: lavender and chamomile essential oils
Our patches are obtained from BioEsse Technologies™. Each patch contains a 50:50 mixture of Lavender and Chamomile essential oils in a 55 microliter standard dose patch. The patches release the aromatherapy over a 2-8 hours period and the diffusion rate of each patch is identical. The back of the patch is layered with a hypoallergenic medical grade adhesive, similar to the material found on ECG leads.
Other Name: Lavendula, chamomilla

No Intervention: Standard therapy ALONE
These infants receive standard care ONLY, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy.



Primary Outcome Measures :
  1. Length of Hospitalization [ Time Frame: Up to 4 months ]
    How long the infant remains hospitalized.


Secondary Outcome Measures :
  1. Length of Medication Therapy [ Time Frame: Up to 4 months ]
    How long the infant requires medication to treat symptoms.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03097484


Locations
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United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
John M. Daniel
Investigators
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Principal Investigator: John M Daniel, MD University of Kentucky
  Study Documents (Full-Text)

Documents provided by John M. Daniel, University of Kentucky:

Publications of Results:

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Responsible Party: John M. Daniel, Fellow, Department of Pediatrics, Division of Neonatology, University of Kentucky
ClinicalTrials.gov Identifier: NCT03097484     History of Changes
Other Study ID Numbers: 15-0159-F2L
First Posted: March 31, 2017    Key Record Dates
Results First Posted: May 14, 2019
Last Update Posted: May 14, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Neonatal Abstinence Syndrome
Syndrome
Disease
Pathologic Processes
Infant, Newborn, Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Hydrocortisone
Anti-Inflammatory Agents