Efficacy of Lavender Essential Oil Chest Wraps in Infants With Bronchiolitis

Официальное название

Efficacy of Lavender Essential Oil Chest Wraps in Improving Cough and Respiratory Distress in Infants With Bronchiolitis: a Multicenter Randomized Controlled Trial

Обзор

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.

Вмешательства

• Препарат 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.
• Другое Control
  Standard care according to national standards.

Первичные конечные точки

• Cough frequency [Срок оценки: Up to 2 days]

Вторичные конечные точки (8)

• Crying episodes [Срок оценки: Up to 2 days]
• Respiratory rate [Срок оценки: Baseline, 1 hour, 4 hours]
• Oxygen supplementation requirement [Срок оценки: Immediately at discharge from hospital]
• Oxygen supplementation duration [Срок оценки: Immediately at discharge from hospital]
• Maximum oxygen supplementation [Срок оценки: Immediately at discharge from hospital]
• Hospital length of stay [Срок оценки: Immediately at discharge from hospital]
• Parental satisfaction assessed with patient satisfaction questionnaire [Срок оценки: Immediately at discharge from hospital]
• Impact on parents assessed by the "Impact of Bronchiolitis Hospitalization Questionnaire" (IBHQ) [Срок оценки: Immediately at discharge from hospital]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швейцария · 2 центра

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

Идентификаторы

NCT: NCT06108648 · 2022-01116

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗