Phase 3 N=38 Randomized Treatment

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

Neonatal Abstinence Syndrome · Aromatherapy

Bottom Line

View on ClinicalTrials.gov: NCT03097484 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2019

Primary outcome: Primary: Length of Hospitalization — 17.8; 11.4 days — p=0.03

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: lavender and chamomile essential oils (Drug)
Age: Pediatric
Sex: All
Sponsor: John M. Daniel
Primary completion: Apr 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Length of Hospitalization	17.8; 11.4	0.03 sig
SECONDARY Length of Medication Therapy	12.7; 7.4	0.05

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03097484). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.