Children With Congenital Diaphragmatic Hernia and the Quality of Their Daily Lives
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Primary Outcome Measure
研究概览
简要总结
Background: Congenital diaphragmatic hernia is a rare disease, resulting from a developmental malformation of the diaphragm. Over the last years, management of the affected children has improved significantly. Despite progress in the treatment, it is still related to a high mortality rate. After birth, congenital diaphragmatic hernias are associated with lung hypoplasia as well as pulmonary hypertension which can in turn lead to cardiac dysfunction. Comorbidities as gastroesophageal reflux or respiratory difficulties, such as chronic pulmonary symptoms or repeated respiratory tract infections are common amongst survivors. However, little is known about the health-related quality of life in children after surgical intervention of their diaphragm.
Aim: This study aims to obtain information on the health-related quality of life in children with congenital diaphragmatic hernia to improve their future long-term management.
Methods: A single-centre prospective study was conducted, examining health-related quality of life of children between five and 18 years of age who were initially treated at the General Hospital of Vienna for congenital diaphragmatic hernia between 2005 and 2019. The validated KIDSCREEN-27 questionnaire was used to assess the health-related quality of life of children with a congenital diaphragmatic hernia, completed by the whole family, including the affected child himself (≥ 8 years old), parents, and siblings. Additionally, a detailed demographic review was obtained.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In this study, patients diagnosed with CDH, born between 2005 and 2019 and treated at the Medical University of Vienna at the Comprehensive Center for Pediatrics were included after giving their written consent for this study. Children with CDH, at least eight years old, their parents, and siblings (eight years or older) were asked to complete the questionnaire.
- •CDH patients answered the KIDSCREEN-27 childrens version questionnaire (see Appendix) if they were aged eight to 18 years.
- •Parents answered the KIDSCREEN-27 parents version questionnaire (see Appendix). If the CDH patients were younger than eight years, only their parents were asked to fill out the questionnaire.
- •If siblings were at least eight years old, they were also asked to complete a questionnaire, which is a newly created version of the KIDSCREEN-27 parents version concerning the quality of life of their CDH affected siblings (see Appendix).
排除标准
- •Missing written informed consent to the study from the CDH patient, parents, or siblings led to exclusion. Parents and siblings of deceased patients were not included.
研究组 & 干预措施
Child (CDH patients)
Parents
Siblings
结局指标
主要结局
Primary Outcome Measure
时间窗: 2005-2019
The primary outcome of this study was to assess HRQoL in CDH patients and compare HRQoL perceptions of CDH patients themselves with the perceptions of their parents and siblings. The statistical analyses were performed using standard statistical software SPSS© (version 29.0.2.0), Microsoft Excel© (version 16.98) and R (version 4.4.2) with two-sided p-values less than 0.05 indicating statistical significance. Continuous variables are expressed in means ± standard deviations, median and ranges. Qualitative variables are summarised in percentages. Both variables use the number of valid obser- vations (N valid). P-values were calculated using the Chi-Square in categorical variables or the two-tailed unpaired t-test in continuous variables.
次要结局
未报告次要终点
研究者
Jennifer Bettina Brandt; MD MSc
Principal Investigator
Medical University of Vienna