Neurocognitive Scores of Predominantly Formula Fed Preterm Infants in Early Childhood Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 3
- 主要终点
- Bayley-III scores at 24 months
研究概览
简要总结
This is a follow-up study of a recently completed trial (17.14.INF) evaluating the growth of pre-term infants. Enrolled children will undergo neurocognitive assessments at 18- and 24-months of corrected age (CA).
详细描述
This is a follow-up study of a recently completed multi-center, prospective, single-arm, open-label interventional trial (17.14.INF - Alprem RTF: NCT03728764) evaluating the growth of pre-term infants receiving a two-stage PTF feeding system while in the neonatal care unit and continuing until 30 days post-discharge.
Enrolled children will undergo neurocognitive assessments at 18- and 24-months of corrected age (CA). The timing of the cognitive assessments aligns with routine check-up visits and reflect the period at which developmental delays may first become evident.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 17 Months 至 25 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants / children born prematurely who were enrolled into the original clinical trial and who are less than 24 m of CA.
- •Having obtained his / her parents' (or his or her legally accepted guardian written informed consent and having evidence of personally signed and dated informed consent document indicating that the child's parent(s) / legal guardian has been informed of all pertinent aspects of the study.
排除标准
- •Infants identified retrospectively as not meeting the inclusion or exclusion criteria for the original study.
结局指标
主要结局
Bayley-III scores at 24 months
时间窗: 24 months of CA
Bayley Scales of Infant and Toddler Development, third edition (Bayley-III) cognitive score at 24 months of corrected age (CA). Composite scores range 40-160, with a mean of 100 and SD of 10 points. A composite score of 70 or less is an indication of a delay in child neurocognitive development.
次要结局
- Bayley-III scores at 18 months(18 months of CA)
- Child temperament scores(At 18 and 24 months of CA)
- Number of healthcare usage(At 18 and 24 months of CA)
- Feeding patterns(At 18 and 24 months of CA)
- Head circumference(At enrollment, 18 and 24 months of CA)
- Developmental Milestone scores(At 18 and 24 months of CA)
- Weight(At enrollment, 18 and 24 months of CA)
- Length/height(At enrollment, 18 and 24 months of CA)