OptiMoM Grows Up: 5.5-year Follow-up of the OptiMoM Fortifier Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Growth
研究概览
简要总结
In Canada, the leading cause of long-term disability in children is being born at very low birth weight (VLBW). To help improve outcomes, nutrition is a modifiable aspect of infant care. Mother's milk is the optimal way to feed VLBW infants; however, many need a supplement of donor milk or preterm formula as not enough mother's milk is available. As the ideal supplement for prolonged feeding and its long-term effects is currently unknown, this study is a prospective follow-up of infants born VLBW who were fed mother's own milk or pasteurized donor breastmilk nutrient enriched with a human milk-based fortifier or a bovine protein-based fortifier. Intakes of donor milk, fortifier type, macronutrients and fatty acids will be explored. Areas of development to be assessed include: cognition, language, motor skills, and body composition. This study will also cross-sectionally examine aspects of eating behaviours, food parenting and the home environment (e.g., stress, home chaos, family functioning) with a term-born comparison. A DNA biorepository will also be created.
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
- 5 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children who were enrolled in the Bovine vs. Human Milk-Based Fortifier Study (NCT02137473)
- •Children who were born >=37 weeks gestation and weighing > 2500g [Term-born comparison group]
排除标准
- •For term-born comparison only: a child with any chromosomal or congenital anomaly affecting growth
结局指标
主要结局
Growth
时间窗: 5.5 years of age
Growth as assessed by weight in kilograms (kg) and height in meters (m) measured by trained staff to assess body mass index (BMI). BMI will be the ratio of weight (kg) to the square of height (m).
Full-Scale Intelligence Quotient (IQ)
时间窗: 5.5 years of age
Measured using the assessor-administered Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV). The WPPSI-IV Full-scale IQ and all composite sub-scales are standardized to a mean of 100, with a standard deviation of 15. Higher scores indicate superior performance.
次要结局
- Vocabulary Acquisition Index(5.5 years of age)
- Diet Quality(5.5 years of age)
- Working Memory Index(5.5 years of age)
- Fluid Reasoning Index(5.5 years of age)
- Blood pressure(5.5 years of age)
- Processing Speed Index(5.5 years of age)
- Body Composition(5.5 years of age)
- Waist circumference(5.5 years of age)
- Verbal Comprehension Index(5.5 years of age)
- Visual Spatial Index(5.5 years of age)
研究者
Deborah O'Connor
Senior Associate Scientist
The Hospital for Sick Children