跳至主要内容
临床试验/NCT05749796
NCT05749796招募中不适用

Investigation of the Relationship Between Development, Neurological Assessment and Object Permanence in High Risk Infants.

Tokat Gaziosmanpasa University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2023年3月1日最近更新:
适应症

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

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

发起方
Tokat Gaziosmanpasa University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Erkan Erol

Assistant Professor

Tokat Gaziosmanpasa University

研究点 (1)

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