2023-504817-56-00招募中4 期
Safe, effective and cost-effective oxygen saturation targets for children and adolescents with respiratory distress: a randomized controlled trial.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 560
- 试验地点
- 10
- 主要终点
- the time from admission to meeting all discharge criteria
研究概览
简要总结
Primary objective: to investigate if an SpO2 threshold of 88% for children and adolescents admitted with respiratory distress results in a safe reduction of length of hospital stay, compared to an SpO2 threshold of 92%.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Children aged 6 weeks to 12 years
- •Hospitalized with lower respiratory distress due to bronchiolitis, viral wheeze or lower respiratory tract infection
- •Requiring supplemental oxygen (SpO2 <92% or otherwise indicated by the treating physician)
排除标准
- •children with other pre-existing respiratory diseases, cardiovascular, neurological or hematological conditions
- •children born <32 weeks gestational age
- •previously included in the study
- •considering questionnaires are only available in Dutch and English, children (of parents) with different languages will be excluded.
- •children (of parents) without a stable internet connection needed for answering questionnaires
- •children already included in other studies, which potentially interfere with this study
结局指标
主要结局
the time from admission to meeting all discharge criteria
the time from admission to meeting all discharge criteria
次要结局
- Length of stay
- Number of PICU admissions
- Time spent on oxygen therapy
- Duration of symptoms
- Time from admission to return to normal health
- Time from admission to return to school/day care
- Unscheduled health care visits after discharge during follow-up
- Patient Quality of Life
- Parental anxiety
- Overall pediatric health
- Economic evaluation
- Reasons for starting oxygen therapy
研究者
Annemie L. M. Boehmer
Scientific
Spaarne Gasthuis
研究点 (10)
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