Bronchiolitis Clearance Airways With Seaserum : a Doubled Blind Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 458
- 试验地点
- 16
- 主要终点
- Duration of resolution of illness (ROI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
neither the patient, the parents nor the investigating physician are aware of the product allocated.
入排标准
- 年龄范围
- 1 Month 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 < 48 hours before emergency consultation
- •Outpatient care after emergency consultation
- •Mild to moderate bronchiolitis according to the "Haute Autorité de Santé 2019" criteria:
- •Respiratory rate over 1 minute >30/minutes and <60/minute ; Heart rate >80/minutes and <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 >50% of the usual quantity over 3 consecutive doses; SpO2 > 92% during sleep ; >94% when awake; >2 months corrected age
- •Parental consent
- •Affiliate to a social security system
排除标准
- •Hospitalization (excluding short stay unit) after emergency consultation
- •Oxygen therapy
- •History of prematurity (birth <34 weeks of amenorrhea)
- •History of invasive ventilation in the neonatal period
- •History of chronic pulmonary or cardiac pathology
- •History of immunodeficiency
- •History of multiple disabilities or neuromuscular pathology
- •History of Ear Nose and Throat pathology affecting the upper airways
- •Impossibility of ensuring the follow-up made necessary by participation in this study
结局指标
主要结局
Duration of resolution of illness (ROI)
时间窗: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
It is the time it takes for the child to return to baseline according to the person administering the care. ROI is defined by ordinal scale from 0 to 4 on which parents globally rate symptoms according to the following categories: (1) worsened, (2) same, (3) improved, (4) resolved. The duration of ROI is the time it takes to obtain a score of 4.
次要结局
- An again medical consultation(At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10)
- Hospitalization(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(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(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(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(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.(At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10)
- Antibiotic use(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(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)(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(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(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 sleep quality in days(At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10)
- Decrease of number of acute middle ear(At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10)