Bronchiolitis Clearance Airways With Seaserum

Официальное название

Bronchiolitis Clearance Airways With Seaserum : a Doubled Blind Randomized Study

Обзор

The objective of this study is to show that the use of electrodialyzed seawater reduces the duration (in days) of symptoms in acute infant bronchiolitis compared with the use of saline solution in infants aged 1 month to less than one year. B-CLASS study is a multicenter, prospective, controlled, randomized, double label blind.

Подробное описание

This is a multicenter, prospective, controlled, randomized in 2 parrallel arms, double blind study. The Infants will be included after written informed consent will be obtained from the patients' parents or legally authorized representatives. Patients will be randomized either in the experimental group (electrodialyzed seawater) or in the control group (saline solution).

Patients' parents will be call by phone at day 1, day 3, day 6, day 10 and day 21 after baseline.

Вмешательства

• Устройство Physiomer
  Infants randomized to the experimental group will be given an electrolyzed seawater solution by their parents for up to 10 days. Dosage is adapted according to the child's age and discomfort: * Infant \< 6 months: half a dose to a single dose administered per nostril 8 times a day. * Infant \> 6 months: one single dose administered per nostril 6 times a day.
• Устройство Saline solution
  Infants randomized to the control group will be given a saline solution by their parents for up to 10 days. Dosage is adapted according to the child's age and discomfort: * Infant \< 6 months: half a dose to a single dose administered per nostril 8 times a day. * Infant \> 6 months: one single dose administered per nostril 6 times a day.

Первичные конечные точки

• Duration of resolution of illness (ROI) [Срок оценки: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10]

Вторичные конечные точки (12)

• An again medical consultation [Срок оценки: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10]
• Hospitalization [Срок оценки: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10]
• Time to improvement of cough in days [Срок оценки: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10]
• Time to improvement of nasal congestion in days [Срок оценки: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10]
• Length with nasopharyngeal decongestion in days [Срок оценки: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10]
• Number of nasopharyngeal decongestion by day [Срок оценки: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10]
• Length of dietary resumption greater than 2/3 of usual intake. [Срок оценки: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10]
• Antibiotic use [Срок оценки: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10]
• Length of community eviction en days [Срок оценки: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10]
• Length of parental absence from work (in days) [Срок оценки: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10]
• Occurrence of secondary events: epistaxis, vomiting, malaise, apnea [Срок оценки: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10]
• Time to improvement in respiratory discomfort in days [Срок оценки: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10]

Критерии участия

Критерии включения

• Infants aged more than 1 month and less than 1 year
• First episode of acute bronchiolitis
• Emergency consultation
• Existence of nasal obstruction
• Onset of symptoms \&amp;lt; 48 hours before emergency consultation
• Outpatient care after emergency consultation
• Mild to moderate bronchiolitis according to the \&amp;#34;Haute Autorité de Santé 2019\&amp;#34; criteria:

Respiratory rate over 1 minute \&amp;gt;30/minutes and \&amp;lt;60/minute ; Heart rate \&amp;gt;80/minutes and \&amp;lt;180/minutes; Absence of respiratory pauses; Absence of superficial breathing; Absence of signs of intense respiratory struggle: involvement of the lower intercostal accessory muscles, sternocleidomastoid muscles, thoracoabdominal swinging, or flapping of the wings of the nose; Feeding \&amp;gt;50% of the usual quantity over 3 consecutive doses; SpO2 \&amp;gt; 92% during sleep ; \&amp;gt;94% when awake; \&amp;gt;2 months corrected age

• Parental consent
• Affiliate to a social security system

Критерии исключения

• Hospitalization (excluding short stay unit) after emergency consultation
• Oxygen therapy
• History of prematurity (birth \&lt;36 weeks of amenorrhea)
• History of invasive ventilation in the neonatal period
• History of chronic pulmonary or cardiac pathology
• History of immune deficiency
• History of polyhandicap or neuromuscular pathology
• History of malformative Ear Nose and Throat pathology affecting the upper airways
• Impossibility of ensuring the follow-up made necessary by participation in this study

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Франция · 8 центров

• Brest, University Hospital — Brest
• Le Mans hospital — Le Mans
• Lille, University hospital — Lille
• Saint-Joseph hospital — Marseille
• Morlaix hospital — Morlaix
• Nantes, University Hospital — Nantes
• Rennes, University hospital — Rennes
• Tours, University hospital — Tours

Идентификаторы

NCT: NCT06177197 · 29BRC23.0193

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗