Effects of Medical Complexity on the Development of Fidgety Movements and Feasibility of Screening Utilizing the General Movement Assessment for Lurie Children's ICU Patients and Graduates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Presence of cerebral palsy
研究概览
简要总结
The purpose of this study is to research a new type of test for cerebral palsy that can be performed earlier, at 10-15 weeks of age (after the due date for premature infants). The test involves a standardized video recording of a baby's natural movements for about 10 minutes. The video recorded movements are evaluated by a special trained observer and also by a computer program. There are some small studies from Europe that suggest that this type of evaluation may be accurate in early diagnosis of cerebral palsy. However, the investigators do not know if this type of evaluation is reliable in large groups of infants, including infants from Children's Memorial Hospital, who tend to be sicker and have more complicated illnesses than many of the European infants. The investigators would therefore like to evaluate whether this type of video recording could be used in the future for early diagnosis of cerebral palsy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Admitted to the NICU/CICU and remain hospitalized at 10-15 weeks postmenstrual age
- •Birth at <28 weeks gestation
- •Birth weight <1000 grams
- •Neurologic risk factors (HIE, abnormal imaging, neonatal seizures, microcephaly)
- •Cardiac surgery during first 3 months of life
- •Severe chronic lung discharge defined as the need for mechanical ventilation at 36 weeks post-menstrual age
- •Discharged home on supplemental oxygen (or if still hospitalized, requiring oxygen at 44 weeks post-menstrual age)
排除标准
- •Significant malformations/amputations of the extremities
- •Recovering from a surgical procedure within 4 weeks of the assessment
- •Physiologic instability precluding movement of the hospital bed or peripheral IV lines that might affect movement of an extremity medication for the purpose of ongoing sedation
结局指标
主要结局
Presence of cerebral palsy
时间窗: 24 months (+/- 6 months) and 4 years (+/- 1 year) of age
次要结局
未报告次要终点
研究者
Raye Ann deRegnier
Associate Prof of Pediatrics
Ann & Robert H Lurie Children's Hospital of Chicago