Clinical trial NCT06108648: Efficacy of Lavender Essential Oil Chest Wraps in Infants With Bronchiolitis
Official title: Efficacy of Lavender Essential Oil Chest Wraps in Improving Cough and Respiratory Distress in Infants With Bronchiolitis: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Bronchiolitis
Keywords: bronchiolitis
infant
cough
essential oil
lavendula
complementary therapies
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 400
Sex: ALL
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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: 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.

Primary outcomes:
measure: Cough frequency
timeFrame: Up to 2 days
Secondary outcomes:
measure: Crying episodes
timeFrame: Up to 2 days
measure: Respiratory rate
timeFrame: Baseline, 1 hour, 4 hours
measure: Oxygen supplementation requirement
timeFrame: Immediately at discharge from hospital
measure: Oxygen supplementation duration
timeFrame: Immediately at discharge from hospital
measure: Maximum oxygen supplementation
timeFrame: Immediately at discharge from hospital
measure: Hospital length of stay
timeFrame: Immediately at discharge from hospital
measure: Parental satisfaction assessed with patient satisfaction questionnaire
timeFrame: Immediately at discharge from hospital
measure: Impact on parents assessed by the "Impact of Bronchiolitis Hospitalization Questionnaire" (IBHQ)
timeFrame: Immediately at discharge from hospital
Other outcomes:
Locations:
city: Fribourg
country: Switzerland
facility: Clinique de pediatrie, HFR Fribourg - Hopital cantonal, Switzerland
city: Geneva
country: Switzerland
facility: Children's' Hospital, University Hospital of Geneva, Switzerland
Study officials:
affiliation: Children's' Hospital, University Hospital of Geneva, Switzerland
name: Klara Posfay-Barbe, MD, PhD
role: STUDY_DIRECTOR
References: