Efficacy of Lavender Essential Oil Chest Wraps in Infants With Bronchiolitis

NCT06108648 | Recruiting Phase 4

• 1 other identifier: 2022-01116
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

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.

Conditions

Bronchiolitis

Keywords

bronchiolitis; infant; cough; essential oil; lavendula; complementary therapies

Outcome Measures

Primary Outcomes (1)

• Cough frequency

  Number of coughs per hour measured with Hyfe CoughMonitor (Hyfe Inc)

  Up to 2 days

Secondary Outcomes (8)

• Crying episodes

  Up to 2 days

• Respiratory rate

  Baseline, 1 hour, 4 hours

• Oxygen supplementation requirement

  Immediately at discharge from hospital

• Oxygen supplementation duration

  Immediately at discharge from hospital

• Maximum oxygen supplementation

  Immediately at discharge from hospital

Study Arms (2)

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.

Drug: Lavender essential oil 10%, diluted in 90% olive oil

Control

ACTIVE COMPARATOR

Standard care: supportive measures according to national standards.

Other: Control

Interventions

Lavender essential oil 10%, diluted in 90% olive oil DRUG

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.

Lavender oil

Control OTHER

Standard care according to national standards.

Control

Eligibility Criteria

• Age: Up to 11 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (2)

Clinique de pediatrie, HFR Fribourg - Hopital cantonal, Switzerland

Fribourg, 1708, Switzerland

RECRUITING

Children's' Hospital, University Hospital of Geneva, Switzerland

Geneva, 1211, Switzerland

RECRUITING

MeSH Terms

Conditions

Bronchiolitis; Cough

Interventions

lavender oil; Olive Oil

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Klara Posfay-Barbe, MD, PhD

  Children's' Hospital, University Hospital of Geneva, Switzerland

  STUDY DIRECTOR

Central Study Contacts

Fabiola Stollar, MD, PhD

CONTACT

+41795534380; Fabiola.stollar@hcuge.ch

Tido von Schoen-Angerer, MD, MPH

CONTACT

+41766159263; tido.von.schoenangerer@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Model Details: Patients are randomized to receive standard care with additional lavender essential oil chest wrap during two nights of hospitalization or standard care alone.

Study Record Dates

• First Submitted: October 8, 2023
• First Posted: October 31, 2023
• Study Start: December 7, 2023
• Primary Completion: March 31, 2026
• Study Completion: April 30, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Investigator who 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.

Locations

CH (2)