2 Year Follow up of COSGOD III (COSGOD III-FU)- Ancillary Retrospective Observational Study to COSGOD III Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 417
- 试验地点
- 11
- 主要终点
- Composite of survival without moderate to severe neurodevelopmental disability (NDD) at 2 years (18 to 30 months) corrected age
研究概览
简要总结
The COSGOD III trial performed follow up until term age or discharge from the neonatal intensive care unit, whatever came first. The first neonate was randomised in September 2017 and the last in October 2021. A prospective follow up of the included neonates until an age of two years was not feasible in the COSGOD III trial since funding for long-term follow-up was not available.
However, data on long-term outcome of the included neonates into COSGOD III trial are of high interest. In many centres, who participated in the COSGOD III trial neonates are assessed routinely for long term outcome in outpatient clinics with Bayleys III/IV test or PARCA-R (Parent Report of Children's Abilities) questionnaire.
Aim of the present study is therefore to analyse in neonates, who were included into the COSGOD III trial, in a retrospective observational study routinely performed long-term survival and neurodevelopmental outcome assessment at a corrected age of 2 years (18-30 months).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Months 至 30 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 50% 2 year neurodevelopmental outcome assessment at 2 years (18 to 30 months)
排除标准
- •< 50% 2 year neurodevelopmental outcome assessment at 2 years (18 to 30 months)
结局指标
主要结局
Composite of survival without moderate to severe neurodevelopmental disability (NDD) at 2 years (18 to 30 months) corrected age
时间窗: 2 years (18 to 30 months) corrected age
A child will be classified with moderate-or-severe NDD, if any of the four following conditions are present: Cognitive or language disability Bayley II test cognitive scale cut-off will be \< 85 Bayley III/IV test, cognitive or language composite scale cut-off will be \< 85 PARCA R non-verbal cognition or language score cut-off will be \< 70 If no standardized developmental assessment is available, informal assessment is possible: less than 5 words Cerebral palsy Gross Motor Function Classification Score (GMFCS) ≥ 2 If no GMFCS is available, informal assessment is possible: Not able to walk alone Visual impairment: Impairment even with glasses or only being able to perceive light or being blind (one or two eyes) Hearing impairment Impairment defined as hearing loss corrected with aids or being deaf
次要结局
未报告次要终点