Trial Outcomes & Findings for The Effect of Aromatherapy on Neonatal Abstinence Syndrome and Salivary Cortisol Levels (NCT NCT03097484)
NCT ID: NCT03097484
Last Updated: 2019-05-14
Results Overview
How long the infant remains hospitalized.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
38 participants
Primary outcome timeframe
Up to 4 months
Results posted on
2019-05-14
Participant Flow
Participant milestones
| Measure |
Standard Therapy ALONE
These infants receive standard care ONLY, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard Therapy ALONE
n=19 Participants
These infants receive standard care ONLY, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy.
|
Standard Therapy Plus Aromatherapy
n=19 Participants
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.
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.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.14 days
STANDARD_DEVIATION 9 • n=19 Participants
|
38.86 days
STANDARD_DEVIATION 5 • n=19 Participants
|
38.50 days
STANDARD_DEVIATION 7.28 • n=38 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=19 Participants
|
11 Participants
n=19 Participants
|
21 Participants
n=38 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=19 Participants
|
8 Participants
n=19 Participants
|
17 Participants
n=38 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
19 participants
n=19 Participants
|
19 participants
n=19 Participants
|
38 participants
n=38 Participants
|
|
Birth Weight
|
2.9 kilograms
STANDARD_DEVIATION 0.5 • n=19 Participants
|
3.1 kilograms
STANDARD_DEVIATION 0.4 • n=19 Participants
|
3.0 kilograms
STANDARD_DEVIATION .45 • n=38 Participants
|
|
Opioid Exposure Only
|
8 Participants
n=19 Participants
|
9 Participants
n=19 Participants
|
17 Participants
n=38 Participants
|
|
Multi-Drug Exposure
|
11 Participants
n=19 Participants
|
10 Participants
n=19 Participants
|
21 Participants
n=38 Participants
|
PRIMARY outcome
Timeframe: Up to 4 monthsHow long the infant remains hospitalized.
Outcome measures
| Measure |
Standard Therapy ALONE
n=19 Participants
These infants receive standard care ONLY, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy.
|
Standard Therapy Plus Aromatherapy
n=19 Participants
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.
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.
|
|---|---|---|
|
Length of Hospitalization
|
17.8 days
Standard Deviation 10.1
|
11.4 days
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: Up to 4 monthsHow long the infant requires medication to treat symptoms.
Outcome measures
| Measure |
Standard Therapy ALONE
n=19 Participants
These infants receive standard care ONLY, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy.
|
Standard Therapy Plus Aromatherapy
n=19 Participants
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.
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.
|
|---|---|---|
|
Length of Medication Therapy
|
12.7 days
Standard Deviation 10.1
|
7.4 days
Standard Deviation 6.1
|
Adverse Events
Standard Therapy ALONE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Therapy Plus Aromatherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place