BronchiolitisPhase 4NCT06108648
Efficacy of Lavender Essential Oil Chest Wraps in Infants With Bronchiolitis
A Phase 4 study testing Lavender essential oil 10%, diluted in 90% olive oil in people with Bronchiolitis, run by University Hospital, Geneva at 2 sites in Switzerland.
Trial summary
The goal of this clinical trial is to learn if lavender essential oil chest wraps relieve cough in infants with bronchiolitis compared to standard care. Furthermore, the researchers will evaluate if breathing difficulties, nighttime awakening and impact on parents will be improved by the lavender oil chest wraps. Read more about this study
- Who is it for?
- Ages Up to 11 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Lavender essential oil 10%, diluted in 90% olive oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 7 Dec 2023to 30 Apr 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 11 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Bronchiolitis: clinical diagnosis based on the combination of respiratory distress (tachypnea, grunting, nasal flaring, retractions, and/or need for supplementary oxygen) and fine crackles sometimes accompanied by wheezing on auscultation.
- Hospitalization.
- Written informed consent.
Who cannot join
- Patients with underlying diseases that impact respiratory or heart function (congenital heart disease, congenital malformation of the lung or airway system and severe chronic lung disease).
- More than 3 episodes of bronchiolitis.
- Critically ill infants who have an immediate need for intensive care unit (ICU) admission.
- Respiratory deterioration needing Continuous positive airway pressure (CPAP) or transfer to ICU during study enrollment.
- Atopic dermatitis, eczema or other skin lesions (particularly on the chest).
- Oncologic disease.
- Premature infants with mild bronchopulmonary dysplasia will not be excluded.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
Clinique de pediatrie, HFR Fribourg - Hopital cantonal, Switzerland
Fribourg, 1708
Benedikt Huber, MD, +4126426711, Benedikt.Huber@h-fr.ch
- Recruiting
Children's' Hospital, University Hospital of Geneva, Switzerland
Geneva, 1211
Fabiola Stollar, MD, PhD, +41795534380, Fabiola.stollar@hcuge.ch
About this study
Official title: Efficacy of Lavender Essential Oil Chest Wraps in Improving Cough and Respiratory Distress in Infants With Bronchiolitis: a Multicenter Randomized Controlled Trial
The goal of this clinical trial is to learn if lavender essential oil chest wraps relieve cough in infants with bronchiolitis compared to standard care. Furthermore, the researchers will evaluate if breathing difficulties, nighttime awakening and impact on parents will be improved by the lavender oil chest wraps. Infants will be randomized to receive standard care with the addition of lavender oil chest wraps or to receive standard care alone. The study will take place in two locations in Switzerland, at the Geneva University Hospital and the Fribourg Cantonal Hospital.
- Conditions
- Bronchiolitis
- Being tested
- Lavender essential oil 10%, diluted in 90% olive oil, Control
- Keywords
- bronchiolitis, infant, cough, essential oil, lavendula, complementary therapies
- Medical subject headings
- Bronchiolitis, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender essential oil 10%, diluted in 90% olive oilDrug
Lavender chest wrap:
Before the first application pour 10-15 ml of lavender essential oil 10% evenly on the cotton cloth.
Put the soaked cotton in the plastic bag, close it and put it to heat in two heating pads (2-5 minutes) so that the oil is distributed on all the fabric. Place the cotton cloth around the patient's chest.
Cover the cotton cloth with a woolen fabric that is 2 cm larger than the cotton cloth.
ControlOther
Standard care according to national standards.
| Study group | Role | What they receive |
|---|---|---|
| Lavender oil | Experimental | Lavender chest wrap:
Before the first application pour 10-15 ml of lavender essential oil 10% evenly on the cotton cloth. Put the soaked cotton in the plastic bag, close it and put it to heat in two heating pads (2-5 minutes) so that the oil is distributed on all the fabric. Place the cotton cloth around the patient's chest. Cover the cotton cloth with a woolen fabric that is 2 cm larger than the cotton cloth. Receives: Drug: Lavender essential oil 10%, diluted in 90% olive oil |
| Control | Active comparator | Standard care: supportive measures according to national standards. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough frequency
Number of coughs per hour measured with Hyfe CoughMonitor (Hyfe Inc)
Measured: Up to 2 days
Secondary outcomes (8)
Crying episodes
Number of crying episodes noted by parents on crying calendar
Measured: Up to 2 days
Respiratory rate
Number of breaths per minute
Measured: Baseline, 1 hour, 4 hours
Oxygen supplementation requirement
Presence of oxygen supplementation during hospital stay (yes/no)
Measured: Immediately at discharge from hospital
Oxygen supplementation duration
Number of hours of oxygen supplementation
Measured: Immediately at discharge from hospital
Maximum oxygen supplementation
Maximum oxygen flow in L/min
Measured: Immediately at discharge from hospital
Hospital length of stay
Hospital length of stay in number of days, Geneva site only
Measured: Immediately at discharge from hospital
Parental satisfaction assessed with patient satisfaction questionnaire
Satisfaction of parents will be measured by a 10-item, four-point Likert scale questionnaire that has a 3-dimensional structure, i.e. overall satisfaction; perceived effectiveness; parental information and involvement. Scale range from 1 (not at all) to 4 (a lot). Higher scores indicate greater satisfaction.
Measured: Immediately at discharge from hospital
Impact on parents assessed by the "Impact of Bronchiolitis Hospitalization Questionnaire" (IBHQ)
Impact from the hospitalization on parents will be measured using IBHQ, a 46-item, four-point Likert scale that has a 12-dimensional structure, i.e. worries and distress; fear for future; guilt; impact on daily organization; physical impact; impact on behaviour with hospitalized child; financial impact; disturbed breastfeeding; physical reaction of hospitalized child; impact on feeding of hospitalized child; impact on behaviour with other children; sibling's reaction. Scale ranges from 1 (not at all) to 4 (a lot). Higher scores indicate higher impact on parents.
Measured: Immediately at discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start7 Dec 2023
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomized to receive standard care with additional lavender essential oil chest wrap during two nights of hospitalization or standard care alone.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabiola Stollar, University Hospital, Geneva
- Investigators
- Klara Posfay-Barbe, MD, PhD, Study director, Children's' Hospital, University Hospital of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108648
- Sponsor's protocol ID
- 2022-01116
- Status last verified
- Mar 2025
- First submitted
- 8 Oct 2023
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board, Independent Ethics Committee, or Research Ethics Board, as applicable, and executes a data use/sharing agreement with the Geneva University Hospitals HUG.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lavender Essential Oil Chest Wraps in Improving Cough and Respiratory Distress in Infants With Bronchiolitis: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06108648
- Acronym / sponsor ID
- 2022-01116
- Conditions
- Bronchiolitis
- Keywords
- bronchiolitis, infant, cough, essential oil, lavendula, complementary therapies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if lavender essential oil chest wraps relieve cough in infants with bronchiolitis compared to standard care. Furthermore, the researchers will evaluate if breathing difficulties, nighttime awakening and impact on parents will be improved by the lavender oil chest wraps. Infants will be randomized to receive standard care with the addition of lavender oil chest wraps or to receive standard care alone. The study will take place in two locations in Switzerland, at the Geneva University Hospital and the Fribourg Cantonal Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients are randomized to receive standard care with additional lavender essential oil chest wrap during two nights of hospitalization or standard care alone.
| Arm | Type | Receives |
|---|---|---|
| Lavender oil | Experimental | Drug: Lavender essential oil 10%, diluted in 90% olive oilLavender chest wrap: Before the first application pour 10-15 ml of lavender essential oil 10% evenly on the cotton cloth. Put the soaked cotton in the plastic bag, close it and put it to heat in two heating pads (2-5 minutes) so that the oil is distributed on all the fabric. Place the cotton cloth around the patient's chest. Cover the cotton cloth with a woolen fabric that is 2 cm larger than the cotton cloth. |
| Control | Active comparator | Other: ControlStandard care: supportive measures according to national standards. |
Who may qualify
- Ages
- Up to 11 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Bronchiolitis: clinical diagnosis based on the combination of respiratory distress (tachypnea, grunting, nasal flaring, retractions, and/or need for supplementary oxygen) and fine crackles sometimes accompanied by wheezing on auscultation.
- Hospitalization.
- Written informed consent.
Key exclusion criteria (7 listed)
- Patients with underlying diseases that impact respiratory or heart function (congenital heart disease, congenital malformation of the lung or airway system and severe chronic lung disease).
- More than 3 episodes of bronchiolitis.
- Critically ill infants who have an immediate need for intensive care unit (ICU) admission.
- Respiratory deterioration needing Continuous positive airway pressure (CPAP) or transfer to ICU during study enrollment.
- Atopic dermatitis, eczema or other skin lesions (particularly on the chest).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lavender essential oil 10%, diluted in 90% olive oilLavender chest wrap: Before the first application pour 10-15 ml of lavender essential oil 10% evenly on the cotton cloth. Put the soaked cotton in the plastic bag, close it and put it to heat in two heating pads (2-5 minutes) so that the oil is distributed on all the fabric. Place the cotton cloth around the patient's chest. Cover the cotton cloth with a woolen fabric that is 2 cm larger than the cotton cloth. | Drug | Lavender oil |
| ControlStandard care according to national standards. | Other | Control |
Primary outcome
Cough frequency
Time frame: Up to 2 days
Number of coughs per hour measured with Hyfe CoughMonitor (Hyfe Inc)
8 secondary outcomes
Crying episodes
Time frame: Up to 2 days
Respiratory rate
Time frame: Baseline, 1 hour, 4 hours
Oxygen supplementation requirement
Time frame: Immediately at discharge from hospital
Oxygen supplementation duration
Time frame: Immediately at discharge from hospital
Maximum oxygen supplementation
Time frame: Immediately at discharge from hospital
Hospital length of stay
Time frame: Immediately at discharge from hospital
Parental satisfaction assessed with patient satisfaction questionnaire
Time frame: Immediately at discharge from hospital
Impact on parents assessed by the "Impact of Bronchiolitis Hospitalization Questionnaire" (IBHQ)
Time frame: Immediately at discharge from hospital
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board, Independent Ethics Committee, or Research Ethics Board, as applicable, and executes a data use/sharing agreement with the Geneva University Hospitals HUG.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Klara Posfay-Barbe, MD, PhD study director
Children's' Hospital, University Hospital of Geneva, Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lavender essential oil 10%, diluted in 90% olive oil in people with Bronchiolitis, run by University Hospital, Geneva at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabiola Stollar, MD, PhD (+41795534380, Fabiola.stollar@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cough frequency (time frame: Up to 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.