Investigation of the Relationship Between Development, Neurological Assessment and Object Permanence in High Risk Infants.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Object Permanence Scale
研究概览
简要总结
The aim of the study is to examine the relationship between development, neurological assessment and object permanence in risky infants aged 7-16 months. The sample of the study will consist of babies between 7-16 months at risk (preterm, low birth weight, asphyxia, hyperbillirubinemia, etc.). Inclusion criteria for the study: Between 7-16 months, having at least one risk factor. Exclusion criteria: Medical complications (eg, severe visual impairment) limiting participation in assessments; autism, down syndrome, or spinal cord injury; diagnosed uncontrolled seizure disorder; or a neurodegenerative disorder. Parents who agreed to participate in the study will be asked to fill out the demographic information questionnaire. Object permanence scale, Bayley III infant and toddler development scale and Hammersmith infant neurologic assessment will be applied to infants.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Months 至 16 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 7-16 months, having at least one risk factor
排除标准
- •Medical complications (eg, severe visual impairment) limiting participation in assessments; autism, down syndrome, or spinal cord injury; diagnosed uncontrolled seizure disorder; or a neurodegenerative disorder
结局指标
主要结局
Object Permanence Scale
时间窗: Baseline
The minimum score of the Object Permanence Scale is 0, and the maximum score is 10. Higher scores indicate better outcome.
The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) motor and cognitive subscales
时间窗: Baseline
Cognitive subscale consists of 91 items and Motor subscale consists of 138 items. Items are scored as 1 (done) and 0 not able to). Higher scores indicate better outcome.
Hammersmith infant neurological assessment
时间窗: Baseline
Each item is individually scored from zero to three, and individual scores are summed to obtain a global optimality score. The overall score can range from a minimum of 0 to a maximum of 78 points.
次要结局
未报告次要终点
研究者
Erkan Erol
Assistant Professor
Tokat Gaziosmanpasa University
