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

Overview

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.

Interventions

• Drug 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.
• Other Control
  Standard care according to national standards.

Primary outcome measures

• Cough frequency [Time frame: Up to 2 days]

Secondary outcome measures (8)

• 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Switzerland · 2 centers

• Clinique de pediatrie, HFR Fribourg - Hopital cantonal, Switzerland — Fribourg
• Children's' Hospital, University Hospital of Geneva, Switzerland — Geneva

Identifiers

NCT: NCT06108648 · 2022-01116

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗