General Movement Assessment - Ancillary Study to SafeBoosC III Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- GMA term age
研究概览
简要总结
In course of the SafeBoosC III trial, we would like to analyse routinely performed GMA as secondary outcome parameter in an ancillary observational study.
First aim is to analyse in surviving neonates included into the SafeboosC III trial any differences between the experimental group group and control group in Global-GMA at term age.
Second aim is to investigate GMOS at term age and if available GMA at 9-16 weeks corrected age.
详细描述
OBJECTIVE In course of the SafeBoosC III trial, we would like to analyse routinely performed GMA as as secondary outcome parameter in an ancillary observational study.
First aim is to analyse in surviving neonates included into the SafeboosC III trial any differences between the experimental group group and control group in Global-GMA at term age.
Second aim is to investigate GMOS at term age and if available GMA at 9-16 weeks corrected age.
HYPOTHESES We hypothesise that the surviving preterm neonates in the experimental group of the SafeBoosC III trial show better results in Global-GMA at term age compared to surviving neonates in the control group.
Furthermore, we hypothesise that the surviving preterm neonates in the experimental group of the SafeBoosC III trial show better results in GMOS at term age and in GMA if available at 9-16 weeks corrected age.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion in the SafeBoosC III Trial
- •Signed informed consent
排除标准
- •Missing written parental informed consent
- •Decision not to conduct full life support
结局指标
主要结局
GMA term age
时间窗: at term age (gestational age between 37+0 to 42+0 weeks)
General movement assessment
次要结局
- GMA 6-9 weeks(if available optionally at a corrected age between 9 to 16 weeks)
研究者
Pichler Gerhard, MD.
Univ. Prof
Medical University of Graz