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临床试验/NCT06870981
NCT06870981招募中不适用

Improving Growth and Neurodevelopment of Very Low Birth Weight Infants Through Precision Nutrition: the Optimizing Nutrition and Milk (Opti-NuM) Project

The Hospital for Sick Children6 个研究点 分布在 2 个国家目标入组 1,100 人开始时间: 2010年10月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
1,100
试验地点
6
主要终点
Cognitive composite score on the Bayley Scales of Infant and Toddler Development.

研究概览

简要总结

Early nutrition critically influences growth, neurodevelopment and morbidity among infants born of very low birth weight (VLBW), but current one-size-fits-all feeding regimes do not optimally support these vulnerable infants. There is increasing interest in "precision nutrition" approaches, but it is unclear which Human Milk (HM) components require personalized adjustment of doses. Previous efforts have focused on macronutrients, but HM also contains essential micronutrients as well as non-nutrient bioactive components that shape the gut microbiome. Further, it is unclear if or how parental factors (e.g. body mass index, diet) and infant factors (e.g. genetics, gut microbiota, sex, acuity) influence relationships between early nutrition and growth, neurodevelopment and morbidity. Understanding these complex relationships is paramount to developing effective personalized HM feeding strategies for VLBW infants. This is the overarching goal of the proposed Optimizing Nutrition and Milk (Opti-NuM) Project.

The Opti-NuM Project brings together two established research platforms with complementary expertise and resources: 1) the MaxiMoM Program* with its clinically embedded translational neonatal feeding trial network in Toronto (Dr. Deborah O'Connor, Dr. Sharon Unger) and 2) the International Milk Composition (IMiC) Consortium, a world-renowned multidisciplinary network of HM researchers and data scientists collaborating to understand how the myriad of HM components contribute "as a whole" to infant growth and development, using systems biology and machine learning approaches. Members of the IMiC Corsortium that will work with on this study are located at the University of Manitoba (Dr. Meghan Azad), University of California (Dr. Lars Bode) and Stanford (Dr. Nima Aghaeepour).

详细描述

Observational study mode:

The Opti-NuM Project is a retrospective secondary data/sample use study.

Time perspective:

Secondary use data and biospecimens accruing from the 2 completed studies DoMINO and OptiMOM (NCT02137473) and 1 ongoing RCT MaxiMoM (NCT05308134) are included in this project.

Sampling method:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
1 Hour 至 21 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Secondary data and biospecimens from participants of the MaxiMoM Platform RCTs

排除标准

  • Data and biospecimens from infants who are not enrolled in the three trials are eligible for this project.

结局指标

主要结局

Cognitive composite score on the Bayley Scales of Infant and Toddler Development.

时间窗: At 18-24 months CA

Our primary outcome is the cognitive composite score on the Bayley Scales of Infant and Toddler Development collected from the medical record or by home-visit by our research staff. The Bayley is the most widely used instrument globally by clinicians and researchers to assess developmental functioning of infants, toddlers and young children across cognitive, language (receptive, expressive) and motor (fine, gross) domains. Cognitive, language and motor composite scores will be standardized to a mean of 100 with a standard deviation of 15. The range on the composite Bayle Scores is from less than 0.1 to more than 99.9 percentile. A score lower than the 10th percentile indicates developmental delay.

次要结局

  • Language composite score from the Bayley Scales of Infant and Toddler Development(At 18-24 months CA)
  • Motor composite score from the Bayley Scales of Infant and Toddler Development(At 18-24 months CA)
  • Weight (g)(Initial hospitalization, approximately 50 days; at 4 months and 18-24 months CA clinic visit.)
  • Length (cm)(Initial hospitalization, approximately 50 days; at 4 months and 18-24 months CA clinic visit.)
  • Head circumference (cm)(Initial hospitalization, approximately 50 days; at 4 months and 18-24 months CA clinic visit.)
  • Serious morbidities(During hospital stay, an average of 60 days.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Deborah O'Connor

Senior Associate Scientist

The Hospital for Sick Children

研究点 (6)

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