A Chart Review Assessing the Effects of Nebulised Hypertonic Saline on Respiratory-related Complications in Children and Young People With Neuromuscular Disease and Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of Hospitalsations Due to Respiratory Exacerbations
研究概览
简要总结
Pneumonia, respiratory exacerbations, and chronic pulmonary infection are important causes of emergency admissions, hospitalisations and death in children with Neuromuscular disorders and Cerebral Palsy. Hence, there is a need for research on how to therapeutically aid airway clearance and decrease respiratory exacerbations. Studies have shown that nebulised Hypertonic Saline is well tolerated, reduces pulmonary exacerbations and improves lung function and Lung Clearance Index in patients with Cystic Fibrosis, and enhances mucociliary clearance in asthmatic patients. Nevertheless, to the investigators' knowledge, there is no available data concerning the use of nebulised Hypertonic Saline in the management of children with Neuromuscular disorders and Cerebral Palsy. This study aims to assess the effectiveness of nebulised Hypertonic Saline to decrease hospitalisations and courses of antibiotics in children with Neuromuscular disorders and Cerebral Palsy.
详细描述
Chart review of children and young people with Neuromuscular disease or Cerebral Palsy who are cared for in the Royal Brompton Hospital and that have been treated with nebulised hypertonic saline for at least 12 months.
To further complement data from hospital records, two questionnaires will be applied. Parents of children who meet criteria will be asked to complete the following questionnaires:
- The National Health and Nutrition Examination Survey (NHANES) for Hospitalisation and access to are - HUQ.010; and
- Questionnaire on Hypertonic Saline treatment.
Children from 10 - 18 years will be asked to complete the Questionnaire on Hypertonic Saline treatment.
AIMS
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with Neuromuscular disease or Cerebral Palsy who have been on treatment with nebulised Hypertonic Saline for at least 12 months.
排除标准
- •Children also diagnosed with cystic fibrosis.
研究组 & 干预措施
After treatment
Children and young people with neuromuscular disease during the 12 months after being prescribed treatment with nebulised saline (0.9% - 7%)
干预措施: Nebulised hypertonic saline (Drug)
结局指标
主要结局
Number of Hospitalsations Due to Respiratory Exacerbations
时间窗: Change from baseline (before treatment) and 12 months after treatment
Number of respiratory exacerbations that required not planned hospitalisation
Change in Antibiotic Courses
时间窗: Change from baseline (before treatment) and 12 months after treatment
Treatments due to respiratory exacerbations
次要结局
- Apnea Index (AI)(Change from baseline (before treatment) and 12 months after treatment)
- %SpO2(Change from baseline (before treatment) and 12 months after treatment)
- Peak Expiratory Flow (PEF)(Change from baseline peak expiratory flow at 12 months after starting treatment with hypertonic saline)
- FVC% Predicted Rate of Decline(Change from baseline (before treatment) and 12 months after treatment)
- Participant's Perception of Treatment(At 12 months after starting treatment with hypertonic saline)
- Parent's or Legal Guardian's Perception of Treatment(At 12 months after starting treatment with hypertonic saline)
- Score on the Ease of Airway Clearance Pictorial Analogue Scale From Children and Young Adults as Participants(Change from baseline (before treatment) and 12 months after treatment)
- Score on the Ease of Airway Clearance From Parents or Legal Guardians(Change from baseline (before treatment) and 12 months after treatment)
- AHI(Change from baseline (before treatment) and 12 months after treatment)
- FEV1% Predicted Rate of Decline(Change from the baseline (before treatment) and 12 months after treatment)
- TcPCO2(Change from baseline (before treatment) and 12 months after treatment)
- FEV1/FVC %Predicted Rate of Decline(Change from baseline (before treatment) and 12 months after treatment)
- Nocturnal ODI(Change from baseline (before treatment) and 12 months after treatment)