Clinical trial
Efficacy of Lavender Essential Oil Chest Wraps in Improving Cough and Respiratory Distress in Infants With Bronchiolitis: a Multicenter Randomized Controlled Trial
Name
2022-01116
Description
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.
Trial arms
Trial start
2023-12-07
Estimated PCD
2025-12-01
Trial end
2025-12-01
Status
Recruiting
Phase
Early phase I
Treatment
Lavender essential oil 10%, diluted in 90% olive oil
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.
Arms:
Lavender oil
Control
Standard care according to national standards.
Arms:
Control
Size
400
Primary endpoint
Cough frequency
Up to 2 days
Eligibility criteria
Inclusion criteria:
* 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.
Exclusion criteria:
* 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients are randomized to receive standard care with additional lavender essential oil chest wrap during two nights of hospitalization or standard care alone.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 400, 'type': 'ESTIMATED'}}
Updated at
2023-12-08
1 organization
Organization
University Hospital Geneva