QUALITY OF LIFE OF CHILDREN BORN VERY PRETERM AT SCHOOL-AGE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- data on quality of life of school-age children born prematurely
研究概览
简要总结
AIMS The aims were 1) to describe the quality of life (QoL) of a cohort of children born very preterm (<28 weeks of gestation) aged 7 to 9 years; 2) to compare children's QoL to the QoL reported by a French general population of reference. 3) to determine whether socio-demographic factors, neonatal features and neurocognitive status were impacting their QoL.
METHODS:
- Multi-centre study: 6 French level three perinatal care units (Marseille, Montpellier, Nantes, Nîmes, Nice and Rouen).
- Inclusion criteria: all infants born before 28 weeks of gestation between January 2005 and December 2007, from 7 to 9 years old of age at the time of evaluation.
- Written agreement to participate: collected from parents.
- Data collection: reports of children's QoL by children and their parents (using standardized validated questionnaires); clinical information about the children, obtained through a medical examination; children neurocognitive profile.
- Duration of inclusion: over 24 months.
- Population: of the six structures, approximately 300 children will be evaluated consistent with the active files of the participating centres and an attrition rate of 30%.
PERSPECTIVES This is one of the first studies to collect self-reported data on quality of life of school-age children (7-9 years) born before 28 weeks of gestation. A better understanding of demographic and clinical determinants of QOL of school-age very preterm children may help clinicians involved in the care of these children in their ethical and medical considerations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child been born between 01/01/2005 and the inclusive 31/12/2007,
- •Extreme premature born Child before 28 weeks of amenorrhea,
- •Child hospitalized after the birth in a level maternity 3 (been born " inborn " or " outborn ")
- •Not dead Child,
- •Child not presenting a cerebral palsy,
- •Child capable of answering a questionnaire in French language,
- •Child among whom the parents(relatives) or the legal representatives accepted the principle of the participation in this study, and having signed a consent,
- •Child granting to participate in the study.
排除标准
- •Child died between the birth and dates her(it) evaluation,
- •Child presenting a cerebral palsy
- •Child among whom the parents(relatives) or the legal representatives refused that their child participates in this study
研究组 & 干预措施
quality of life
干预措施: questionary on quality of life (Other)
结局指标
主要结局
data on quality of life of school-age children born prematurely
时间窗: 3 years
次要结局
- better understanding of demographic and clinical determinants of QOL of school-age(3 years)