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临床试验/NCT00677066
NCT00677066已完成3 期

A Randomised Controlled Trial: Home Oxygen Therapy Versus Hospital Oxygen Therapy for Children With Acute Bronchiolitis

Princess Margaret Hospital for Children2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2007年8月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
44
试验地点
2
主要终点
Readmission to hospital

研究概览

简要总结

Home oxygen therapy is considered an appropriate and relatively safe option for children with chronic respiratory problems such as chronic lung disease of prematurity, but the use of home oxygen therapy for children with acute respiratory problems is limited. With the recent establishment of a "Hospital in The Home" (HiTH) program at our institution, we sought to determine the safety, parental satisfaction and economic advantage of home oxygen therapy for children with acute bronchiolitis compared with traditional inpatient hospitalization.

详细描述

Acute bronchiolitis is the most common reason for hospital admission in children aged less than 1 year in developed countries. Over the last 25 years, hospitalization rates and admission duration have increased dramatically, resulting in substantial health care costs for both institutions and individual families.

There are currently no pharmacological therapies for acute bronchiolitis that have been shown to consistently alter the natural history of this disease. Current evidence suggests that management is essentially supportive, consisting of oxygen supplementation if the child is hypoxic and nasogastric feeds or intravenous fluids if the child is dehydrated. Oxygen supplementation is the principal determinant of the length of hospital admission for children with acute bronchiolitis and the need for supplemental oxygen is generally considered to be an absolute indication for hospitalization. However, Bajaj et al demonstrated that a carefully selected population of children with acute bronchiolitis can be managed safely with home oxygen therapy.

The escalating demand and cost of health care has driven health reforms in many countries, including Australia and the United Kingdom. These reforms have included the development of services that allow patients with a range of illnesses to be managed safely in their own home rather than hospital. Such services have been well established for children with a number of chronic conditions and although managing children with acute illnesses at home is not a new strategy, this model of care is increasingly considered an alternative to traditional in-patient hospitalisation. In addition to the financial benefits of transferring care to the patients' homes for health care providers and families, children and parents report a strong preference for such models of care.

Home oxygen therapy is considered an appropriate and relatively safe option for children with chronic respiratory problems such as chronic lung disease of prematurity, but the use of home oxygen therapy for children with acute respiratory problems is limited. With the recent establishment of a "Hospital in The Home" (HiTH) program at our institution, we sought to determine the safety, parental satisfaction and economic advantage of home oxygen therapy for children with acute bronchiolitis compared with traditional inpatient hospitalization.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
3 Months 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 3 - 24 months of age (corrected gestation)
  • Clinical diagnosis of acute bronchiolitis
  • Adequate feeding (>50% normal) & hydration
  • O2 saturation >92% on <1litre/minute nasal cannula oxygen.
  • Observed and clinically stable for at least 24 hours in hospital
  • Pass modified "safety in air test "
  • Caregivers must be counseled about risk of smoking around a child receiving oxygen supplementation
  • Caregivers must be adequately educated about home oxygen
  • HiTH nurses able to visit at home at least twice daily, in addition to daily phone call
  • Paediatrician agrees that child is eligible for recruitment in study

排除标准

  • Pre-existing cardiac, pulmonary (including chronic lung disease of infancy, cystic fibrosis and congenital or acquired airway anomalies), and neuromuscular disorders
  • History of apnea
  • Prematurity <34 weeks gestation

结局指标

主要结局

Readmission to hospital

时间窗: Within 7 days of discharge

次要结局

  • parent satisfaction(discharge)
  • Number of days in hospital(days)

研究者

发起方
Princess Margaret Hospital for Children
申办方类型
Other

研究点 (2)

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