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

NCT03097484 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 15-0159-F2L
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neonatal Abstinence Syndrome; Aromatherapy

Outcome Measures

Primary Outcomes (1)

• Length of Hospitalization

  How long the infant remains hospitalized.

  Up to 4 months

Secondary Outcomes (1)

• Length of Medication Therapy

  Up to 4 months

Study Arms (2)

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.

Drug: lavender and chamomile essential oils

Standard therapy ALONE

NO INTERVENTION

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

Interventions

lavender and chamomile essential oils DRUG

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.

Also known as: Lavendula, chamomilla

Standard therapy plus Aromatherapy

Eligibility Criteria

• Age: Up to 2 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• John M. Daniel: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Related Publications (17)

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  PMID: 23147978 RESULT

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  PMID: 24752403 RESULT

• Field T, Diego M, Hernandez-Reif M, Cisneros W, Feijo L, Vera Y, Gil K, Grina D, Claire He Q. Lavender fragrance cleansing gel effects on relaxation. Int J Neurosci. 2005 Feb;115(2):207-22. doi: 10.1080/00207450590519175.

  PMID: 15764002 RESULT

• Field T, Field T, Cullen C, Largie S, Diego M, Schanberg S, Kuhn C. Lavender bath oil reduces stress and crying and enhances sleep in very young infants. Early Hum Dev. 2008 Jun;84(6):399-401. doi: 10.1016/j.earlhumdev.2007.10.008. Epub 2007 Nov 28.

  PMID: 18053656 RESULT

• Filippelli AC, White LF, Spellman LW, Broderick M, Highfield ES, Sommers E, Gardiner P. Non-Insertive Acupuncture and Neonatal Abstinence Syndrome: A Case Series from an Inner City Safety Net Hospital. Glob Adv Health Med. 2012 Sep;1(4):48-52. doi: 10.7453/gahmj.2012.1.4.007.

  PMID: 24078899 RESULT

• Hayes MJ, Brown MS. Epidemic of prescription opiate abuse and neonatal abstinence. JAMA. 2012 May 9;307(18):1974-5. doi: 10.1001/jama.2012.4526. Epub 2012 Apr 30. No abstract available.

  PMID: 22546607 RESULT

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  PMID: 23589814 RESULT

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  PMID: 25405293 RESULT

• Namazi M, Amir Ali Akbari S, Mojab F, Talebi A, Alavi Majd H, Jannesari S. Aromatherapy with citrus aurantium oil and anxiety during the first stage of labor. Iran Red Crescent Med J. 2014 Jun;16(6):e18371. doi: 10.5812/ircmj.18371. Epub 2014 Jun 5.

  PMID: 25068058 RESULT

• Olson SL. Bedside musical care: applications in pregnancy, childbirth, and neonatal care. J Obstet Gynecol Neonatal Nurs. 1998 Sep-Oct;27(5):569-75. doi: 10.1111/j.1552-6909.1998.tb02624.x.

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  PMID: 24136995 RESULT

• Pahl A, Young L, Buus-Frank ME, Marcellus L, Soll R. Non-pharmacological care for opioid withdrawal in newborns. Cochrane Database Syst Rev. 2020 Dec 21;12(12):CD013217. doi: 10.1002/14651858.CD013217.pub2.

  PMID: 33348423 DERIVED

MeSH Terms

Conditions

Neonatal Abstinence Syndrome

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

Interpretation is limited by being a single-center, open-label trial.

Results Point of Contact

• Title: John Bauer, MD
• Organization: University of Kentucky

john.bauer@uky.edu

859-218-2927

Study Officials

• John M Daniel, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Fellow, Department of Pediatrics, Division of Neonatology

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 31, 2017
• Study Start: July 25, 2015
• Primary Completion: April 30, 2017
• Study Completion: April 30, 2017
• Last Updated: May 14, 2019
• Results First Posted: May 14, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)