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Phase 3 Completed N=38 Randomized Treatment

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

Source: ClinicalTrials.gov NCT03097484 ↗
Enrolled (actual)
38
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Length of Hospitalization — 17.8; 11.4 days — p=0.03
◆ Published Evidence
Highly cited
221citations · ~18 / year
Kangaroo mother care to reduce morbidity and mortality in low birthweight infants.
The Cochrane database of systematic reviews · 2014 · High-confidence link

Summary

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

Linked Publications (5)

  • Kangaroo mother care to reduce morbidity and mortality in low birthweight infants.
    The Cochrane database of systematic reviews · 2014 · 221 citations · High-confidence link
  • Lavender fragrance cleansing gel effects on relaxation.
    The International journal of neuroscience · 2005 · 121 citations · High-confidence link
  • A randomized placebo-controlled trial of massage therapy on the immune system of preterm infants.
    Pediatrics · 2012 · 118 citations · High-confidence link
  • Lavender bath oil reduces stress and crying and enhances sleep in very young infants.
    Early human development · 2008 · 111 citations · High-confidence link
  • Influence of prone positioning on premature newborn infant stress assessed by means of salivary cortisol measurement: pilot study.
    Revista Brasileira de terapia intensiva · 2014 · 40 citations · Open access · High-confidence link

Outcome Measures

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

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) and the linked publication. 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. Informational only — not medical advice.

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