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临床试验/NCT01618175
NCT01618175Unknown不适用

Home Oxygen Treatment of Childhood Acute Bronchiolitis

Soroka University Medical Center0 个研究点目标入组 85 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
85
主要终点
Rate of hospital readmission within 10 days after discharge with home oxygen

研究概览

简要总结

Background: acute bronchiolitis (AB) is a common reason for hospitalization of infants in all population groups, and is usually due to respiratory syncytial virus (RSV) infection. The main cause for hospitalization is often a need for oxygen, but can also include high fever (with a suspected secondary bacterial infection) or increasing respiratory distress. In a minority of cases (some of which can be identified in advance by defining risk groups) a serious illness may develop, including risk of respiratory failure and death. Most cases will just require supplemental oxygen and suction of secretions from the nose (as listed in the recommendations of the American Academy of Pediatrics - AAP). However, this apparently "simple" treatment still requires continued hospitalization. This results in a sharp increase in bed occupancy in Israeli hospital pediatric departments in the winter months. In recent years two studies from developed countries have been published where safety has been demonstrated for home oxygen treatment for babies with AB. However, feasibility studies have not been published yet, for example for populations living in poor conditions. The General Health Services (Klalit) in Israel provides integrated hospital and community health service to the majority of the population living o in our region, thus presenting an opportunity for optimal interventions related to this disease.

详细描述

Objective

To develop a model of community based safe handling of AB in various communities in southern Israel.

Methods: A prospective intervention study examining the safety and health expenditures in infants with AB treated first in hospital but then discharged earlier with home oxygen while monitored in the community.

Contribution to the focus areas, and the impact of results on health policy planning: 1) Reducing hospitalization days and general financial savings. 2) Ability to implement these findings to populations with variable socio-economic backgrounds. 3) Prevention of nosocomial infections related morbidity.

Innovation and uniqueness in the study: test of this hypothesis precisely in our region, where populations have different socio-economic backgrounds, will build a model that may be suitable for all levels of society.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Age: 2-24 months, but age postconception of over 44 weeks.
  • Ac. bronchiolitis clinical diagnosis: acute respiratory illness including nasal congestion, coughing and wheezing or crackles simplified, Tachypnea or retractions of the chest.
  • X-ray confirms a viral diagnosis of bronchiolitis
  • First attack of wheezing
  • O2 Saturation < 91% room air while arrival to the ER
  • The baby and his family have a way to return to the ER after discharge
  • The family lives a distance of less than 30 minutes drive from the center of Emergency Medicine
  • The baby lives in an environment with no smoking
  • The baby's family is available by phone
  • The baby's family is ready for continuous monitoring of the baby at home 11th. Disease severity index (RDSS) of < 4 (see definitions)

排除标准

  • Previous morbidity: cardiac, pulmonary, neuromuscular, nutrition (including FTT). And congenital or acquired airway problem.
  • Age since conception is less than -44 weeks.
  • History of apneas
  • Bacterial pneumonia suggested by a localized-focal finding on X-ray
  • Previous wheezing attack
  • O2 Saturation > 92% on room air
  • Family has no transportation available follow-up visits
  • The family lives at a distance greater than 30 minutes drive from the medical facility
  • The baby was treated with steroids for this attack
  • There is no continuous monitoring of the baby at home

结局指标

主要结局

Rate of hospital readmission within 10 days after discharge with home oxygen

时间窗: Within 10 days from discharge home with O2

Readmission to the hospital because of (1) increased oxygen requirement (\> 1 L\\ minute through the nose) to maintain oxygen saturation of\> 92%. (2) event of apnea. 3) feeding of less than 50% of normal with clinical evidence of dehydration, (4) the parents or pediatrician wish remove the child from the study.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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