Safe, Effective and Cost-Effective Oxygen Saturation Targets for Children and Adolescents With Respiratory Distress: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 566
- 试验地点
- 16
- 主要终点
- Time to meeting all discharge criteria
研究概览
简要总结
The goal of this clinical trial is to find out at which lower limit for saturation (amount of oxygen in the blood) we can best give extra oxygen to children that have been admitted for shortness of breath. We hope to accomplish a shorter period of illness for these children and that they can be discharged home earlier. Participants will receive supplemental oxygen if their blood oxygen levels are below 88% or below 92%. After admission, (parents of) participating children will fill out questionnaires. We will compare the two groups on their hospitalization duration and recovery.
In other words, is it better to maintain a lower limit of 88% saturation or a lower limit of 92% in children admitted for shortness of breath?
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
- None
入排标准
- 年龄范围
- 6 Weeks 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6 weeks to 12 years of age (corrected age for children with gestational age < 37 weeks)
- •hospitalized with respiratory distress due to bronchiolitis, viral wheeze or lower respiratory tract infection, as diagnosed by the treating physician. Viral wheeze can only be diagnosed below the age of 6 years.
- •requiring supplemental oxygen as per usual care (SpO2 <92% or for treating symptoms of respiratory distress as determined by the treating physician
- •As respiratory distress in children with an asthma attack is mainly driven by hypoxia, they are at risk of undertreatment in the acute phase of the attack. Therefore, children aged 6-12 years of age with an asthma attack are excluded from this study.
排除标准
- •children with, except for the studied diseases, pre-existing cardiopulmonary, neurological or hematological conditions (e.g. congenital thoracic malformation, airway malacia, post infectious bronchiolitis obliterans, childhood interstitial lung disease. primary immune deficiency)
- •children born <32 weeks gestational age
- •children already included in other studies, which potentially interfere with this study
- •children (of parents) without a stable internet connection needed for answering questionnaires
- •children previously included in the current study
- •considering questionnaires are only available in Dutch and English, children (of parents) with different languages will be excluded.
研究组 & 干预措施
88% oxygen saturation threshold
Patients in this arm will receive supplemental oxygen when SpO2 falls below 88% or when other clinical symptoms indicate a need for supplemental oxygen.
干预措施: Oxygen saturation threshold (Other)
92% oxygen saturation threshold
Patients in this arm will receive supplemental oxygen when SpO2 falls below 92% or when other clinical symptoms indicate a need for supplemental oxygen.
干预措施: Oxygen saturation threshold (Other)
结局指标
主要结局
Time to meeting all discharge criteria
时间窗: Discharge criteria are checked daily during admission up to discharge (generally a few days up to a week but longer if admission lasts longer) and the time and date at which all discharge criteria have been met will be recorded.
Time in hours from admission to meeting all discharge criteria Discharge criteria include: * No need for supplemental oxygen for 4 hours, including a period of sleep for children aged \< 2 years * Clinically fit for discharge with normal or minimally increased respiratory rate AND no or mild respiratory distress, as judged by nurses and physicians using the Parshuram et al scoring system, commonly used in Dutch paediatric practice as part of the Pediatric Early Warning Scale\]. * No need for in-hospital feeding or medication by nasogastric tube (NGT). * No need for in-hospital intravenous treatment. * No need for in-hospital nebulized bronchodilator treatment. * No need for in-hospital treatment with metered dose inhalator inhalations more often than every 3 hours. * No need for high flow delivered by high flow nasal cannula or nasal prongs.
次要结局
- Length of stay(During admission)
- Time on oxygen therapy(During admission)
- Return to normal health(from admission to 90 days after discharge)
- Pediatric Intensive Care Unit (PICU) admissions(During admission)
- Time to return to school/daycare(from admission to 90 days after discharge)
- Unscheduled health care visits or admissions after discharge(from admission to 28 days after discharge)
- Parental anxiety(at discharge, 7 and 28 days follow-up)
- Economic evaluation(Up to 90 days after discharge)
- Duration of symptoms(from admission to 90 days after discharge)
- Patient quality of life(at discharge, 7, 28 and 90 days follow-up)
- Overall pediatric health(at discharge, 7, 28 and 90 days follow-up)