Early Detection and Prevention of Health Complications in Premature Infants - Early Detection of Developmental Abnormalities of Preterm Infants at 5 Years of Age
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 4
- 主要终点
- Proportion of premature infants with identified pathology at 5 years (overall, by detected pathology)
研究概览
简要总结
The project is a national, prospective, multicenter, interventional pilot project focused on the follow up of 5 year old children that were born prematurely.
The primary aim of the project is to prepare, test, and develop a proposal for a national methodology for the care of children born prematurely. This will minimize the negative impacts on the overall development of the child and the family of the prematurely born children.
详细描述
The project is a national, prospective, multicenter, interventional pilot project focused on the follow up of 5 year old children that were born prematurely.
The main goal of the project is establishing a methodology for the long-term monitoring of premature infants (in the area of developmental anomalies) and their evaluation at the age of 5 years.
The main objective of this activity is to validate this screening process, which will benefit 210 patients in 2 perinatal and 2 intermediate centers. The child will undergo a comprehensive pediatric examination, including basic vision, speech, and psychomotoric assessments (MABC-2 and IDS-P). If any concerns are identified, the child will be referred to an appropriate specialist. The timeliness of this check-up has significant positive impact on both the patient and their family.
The project is supported by the European Social Fund (Operational Program Employment plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22_005/0002020.
The study has been reviewed and approved by multiple local ethical committees. The listed IRB represents the lead national ethical committee overseeing the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed consent for participation in the project and consent for the processing of personal data.
- •Children born before 37 weeks of gestation, aged 5 years, growing up in a Czech-speaking environment.
- •To ensure valid linkage of all data sources, the children must have been born to parents with Czech citizenship.
排除标准
- •Unsigned consent for participation in the project and consent for the processing of personal data.
- •Severe psychomotor retardation .
- •Severe congenital malformations.
研究组 & 干预措施
5 year old children born prematurely
干预措施: Pediatric check-up (Other)
结局指标
主要结局
Proportion of premature infants with identified pathology at 5 years (overall, by detected pathology)
时间窗: During study participation (up to 3 days)
Proportion of premature infants referred to a specialized center (overall, by detected pathology)
时间窗: During study participation (up to 3 days)
次要结局
未报告次要终点