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

Primary Purpose

Neonatal Abstinence Syndrome, Aromatherapy

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
lavender and chamomile essential oils
Sponsored by
John M. Daniel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Abstinence Syndrome

Eligibility Criteria

undefined - 2 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kentucky

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Standard therapy plus Aromatherapy

Standard therapy ALONE

Arm Description

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.

These infants receive standard care ONLY, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy.

Outcomes

Primary Outcome Measures

Length of Hospitalization
How long the infant remains hospitalized.

Secondary Outcome Measures

Length of Medication Therapy
How long the infant requires medication to treat symptoms.

Full Information

First Posted
March 15, 2017
Last Updated
April 23, 2019
Sponsor
John M. Daniel
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1. Study Identification

Unique Protocol Identification Number
NCT03097484
Brief Title
The Effect of Aromatherapy on Neonatal Abstinence Syndrome and Salivary Cortisol Levels
Official Title
The Effect of Aromatherapy on Neonatal Abstinence Syndrome and Salivary Cortisol Levels
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 25, 2015 (Actual)
Primary Completion Date
April 30, 2017 (Actual)
Study Completion Date
April 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
John M. Daniel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Abstinence Syndrome, Aromatherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard therapy plus Aromatherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard therapy ALONE
Arm Type
No Intervention
Arm Description
These infants receive standard care ONLY, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy.
Intervention Type
Drug
Intervention Name(s)
lavender and chamomile essential oils
Other Intervention Name(s)
Lavendula, chamomilla
Intervention Description
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.
Primary Outcome Measure Information:
Title
Length of Hospitalization
Description
How long the infant remains hospitalized.
Time Frame
Up to 4 months
Secondary Outcome Measure Information:
Title
Length of Medication Therapy
Description
How long the infant requires medication to treat symptoms.
Time Frame
Up to 4 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
2 Weeks
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John M Daniel, MD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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The Effect of Aromatherapy on Neonatal Abstinence Syndrome and Salivary Cortisol Levels

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