Taiwan Preterm Infant Database: Analysis and Comparison of Birth Conditions and Exploration of Prognostic Factors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6,000
- 试验地点
- 1
- 主要终点
- Bayley-III Language Composite Score
研究概览
简要总结
The purpose of this study is to conduct a long-term follow-up of preterm infants with different birth conditions, aiming to provide data and resources for future care and to identify predictive and influencing factors related to their functional development over time. It is hypothesized that (1) preterm infants with varying birth conditions, such as birth weight and gestational age, will exhibit different developmental outcomes, and that the establishment of a Taiwan-specific preterm infant database is essential due to the lack of comprehensive local data and ethnic variations in gestational patterns; and (2) neonatal factors, including gestational age, birth weight, and postnatal complications (e.g., pneumonia, seizures, hypoxia), serve as potential risk factors influencing later developmental trajectories.
详细描述
This study uses Taiwan's Preterm Infant Database to analyze gestational age, birth conditions, and long-term developmental outcomes in preterm infants. Participants are classified by gestational age and birth weight into subgroups, with demographic, clinical, and follow-up data (e.g., Bayley-III, neurodevelopmental exams, rehabilitation records) systematically collected. All data are de-identified, coded, and validated, with confidentiality maintained under IRB oversight. Statistical methods include ANOVA, chi-square, Kruskal-Wallis, repeated-measures ANOVA, and multiple regression models to identify predictive and risk factors. Standardized procedures govern data collection, management, and analysis, with strategies to address missing or inconsistent values. This framework ensures rigor, supports predictive modeling, and provides clinically relevant insights to guide early intervention and healthcare strategies.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Bayley-III Language Composite Score
时间窗: Baseline
Standardized language domain score from the Bayley-III. Scale range: higher scores indicate better language development.
Bayley-III Motor Composite Score
时间窗: Baseline
Standardized motor domain score from the Bayley-III. Scale range: higher scores indicate better motor development.
Head Circumference
时间窗: Baseline
Head circumference measured in centimeters (cm).
Body Length
时间窗: Baseline
Body length measured in centimeters (cm).
Body Weight
时间窗: Baseline
Body weight measured in kilograms (kg).
Neurological Examination Score
时间窗: Baseline
Results from standardized neurological assessment. Scale range: higher scores indicate better neurological function.
Mobility Ability Score
时间窗: Baseline
Functional mobility assessed using age-appropriate developmental checklist. Scale range: higher scores indicate greater independence.
Presence of Medical Complications/Comorbidities
时间窗: Baseline
Recorded as a binary variable (Yes/No). Unit: Proportion (%)
Rehabilitation Participation
时间窗: Baseline
Frequency of rehabilitation sessions per week based on clinical records. Unit: Sessions per week
Bayley-III Cognitive Composite Score
时间窗: Baseline
Standardized cognitive domain score from the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III). Scale range: higher scores indicate better cognitive development.
次要结局
未报告次要终点