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临床试验/NCT00817466
NCT00817466Unknown4 期

Bronchiolitis All-study, SE-Norway What is the Optimal Inhalation Treatment for Children 0-12 Months With Acute Bronchiolitis?

Oslo University Hospital9 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
500
试验地点
9
主要终点
No of hours before deemed fit for discharge from hospital

研究概览

简要总结

Bronchiolitis is a common lower respiratory disease typically affecting infants and children generally younger than 2 years of age. The disease leads to hospital admissions, is a major cause for hospitalisation of young children and infants during winter epidemics, may be severe sometimes requiring ventilatory support and rarely death. The clinical disease as described by Court is characterised by nasal flaring, tachypnoea, dyspnoea, chest recessions, crepitations and sometimes sibiliations. Respiratory Syncytial virus is the most common cause, but also other respiratory vira may cause the disease. Bronchiolitis is a well known risk factor of asthma development in childhood1,2.

Management is generally supportive, whereas symptom reducing therapy is debated with no international consensus. Furthermore, there are many unresolved questions related to the prognosis of bronchiolitis, its role in development of chronic lung disease in particular regarding the association between early bronchiolitis and asthma development. The present project will particularly focus on: 1)Treatment efficacy related to various outcomes during active disease, 2) retrospectively assess treatment efficacy in relation to later development of allergic disease, 3) assess the role between different vira and asthma prognosis as well as 4) identify possible prognostic factors involved in the progression from bronchiolitis to further airways disease.

详细描述

OVERALL AIMS OF THE STUDY:

  1. To compare the efficacy of two common treatments by determining whether inhalation treatment with racemic adrenaline is more effective than saline inhalations in acute bronchiolitis in children younger than 12 months throughout an hospital admission, as well as to define the optimal inhalation treatment intervals.
  2. To identify clinical and virological risk factors for development of persisting obstructive airways disease after an initial bronchiolitis, and to assess if specific vira or subsequent asthma development influences the efficacy of bronchiolitis management.
  3. To assess whether hospital admissions for bronchiolitis has increased in parallel with the increase in childhood asthma seen in the last 10-15 years.

METHODS AND STUDY PROGRESSION

Design:

This multicenter study will be performed after initial appropriate common training by all participating.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
— 至 11 Months(Child)
性别
All
接受健康志愿者

入选标准

  • children 0 inclusive 11 months admitted to the hospital with symptoms and signs of acute bronchiolitis during the winter season of 2009-
  • bronchiolitis as defined on clinical criteria by SDM Court (Post graduate medical journal 1973).
  • Clinical score of 4 or more (Kristjansson, Arch.Dis.Child. 1993)
  • Exclusion criteria:
  • Use of regular inhaled corticosteroids.
  • Use of systemic or inhaled corticosteroids within the last 4 weeks.
  • Significant cardiac, previous severe or persisting (>4 weeks) respiratory disease, neurologic, immunologic, oncologic or other disease that may significantly influence the outcomes, including Down's syndrome. Prematurity per se is not a reason for exclusion.
  • One single previous mild-moderate episode suspect of bronchial obstruction is not an exclusion criterion, >1 are.

排除标准

  • 未提供

研究组 & 干预措施

Racemic adrenaline, fixed intervals

Experimental

Active drug with fixed intervals of inhalation, adjusted at least every 24h.

干预措施: Racemic adrenaline (Drug)

Racemic adrenalin, on demand

Experimental

Racemic adrenaline, inhalations on demand (max every 2 hrs)

干预措施: Racemic adrenaline (Drug)

Saline, fixed intervals

Active Comparator

Saline inhalation fixed intervals, adjusted at least every 24 hrs

干预措施: Isotonic saline (Drug)

saline on demand

Active Comparator

Saline inhalations on demand, max every 2 hrs, adjusted every 12 hrs

干预措施: Isotonic saline (Drug)

结局指标

主要结局

No of hours before deemed fit for discharge from hospital

时间窗: Throughout the hospital stay

次要结局

  • Clinical score measured by doctor(Throughout the hospital stay. Daily before and 30min after inhalation in daytime.)
  • Need for feeding support (no. of hours)(Throughout the hospital stay.)
  • Clinical status (by parents as well as nurses) every 12 hrs(prior to inhalation every morning and evening)
  • Need for supplementary oxygen.(Throughout the hospital stay.)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (9)

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