Efficacy of Lavender Essential Oil Chest Wraps in Infants With Bronchiolitis
ConditionBronchiolitis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeUp to 11
SponsorUniversity Hospital, Geneva
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Lavender essential oil 10%, diluted in 90% olive oil
DrugLavender 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
Other interventionStandard care according to national standards.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Lavender oilExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cough frequency
Number of coughs per hour measured with Hyfe CoughMonitor (Hyfe Inc)
Time frame
Up to 2 daysSecondary outcomes
1
Crying episodes
Number of crying episodes noted by parents on crying calendar
Time frame
Up to 2 days2
Respiratory rate
Number of breaths per minute
Time frame
Baseline, 1 hour, 4 hours3
Oxygen supplementation requirement
Presence of oxygen supplementation during hospital stay (yes/no)
Time frame
Immediately at discharge from hospital4
Oxygen supplementation duration
Number of hours of oxygen supplementation
Time frame
Immediately at discharge from hospitalSponsors and contacts
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Source ClinicalTrials.gov