The Effect of Myelin-Relevant Nutrients in Infant Formula on Brain Myelination and Cognitive Development
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 189
- 试验地点
- 2
- 主要终点
- Brain De novo myelination
研究概览
简要总结
Research study on the role of early life nutrition on brain and cognitive development during infancy and early childhood. Two blends of myelin-relevant nutrients at different levels were compared and a breastfed group was considered as epidemiological reference.
详细描述
This nutritional intervention study involved assessments in both the mother and her infant. The mother was asked to complete self-report questionnaires and to undergo a brief cognitive assessment. If the mother was not breastfeeding, a study product was provided and was consumed by the infant daily up to 12 months of life. The study also involved magnetic resonance imaging (MRI) brain scans of the infant's brain while asleep as well as evaluation of cognitive outcomes, including general cognitive development, and social-emotional development.
Once all trial subjects completed the 6-month timepoint (intervention part), an inferential statistical analysis of all data up to 6 months was performed.
Product codes (blinding) were broken to compare groups and an appropriate operational framework was put in place to maintain the individual assignment unknown to the Sponsor and Sites until the end of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Double blind - Infant Formula arms are blinded;
- Reference Arm - unblinded epidemiological reference arm
- Allocation: Randomized for formula arms, efficacy study
入排标准
- 年龄范围
- 2 Weeks 至 6 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Term infants (≥ 37 weeks)
- •Neuro typical development
- •No major risk factors for learning, neurologic, or psychiatric disorder
- •Between 2 weeks and maximum 5 weeks of age. If mother is breastfeeding she can choose the infant begin the trial prior 2 weeks.
- •Parents/legal guardians willing and able to complete the informed consent process
排除标准
- •Delayed birth (> 41 weeks gestation)
- •Birth Weight < 2000 g or small for gestation age or large for gestational age
- •Psychopharmacological treatment of mother using prohibited medications during pregnancy
- •In utero exposure to alcohol abuse or illicit substances as per the American College of Obstetricians and Gynecologists
- •Abnormalities on fetal ultrasound
- •Complicated pregnancy
- •Neonatal intensive care unit admission and/or emergency surgical delivery
研究组 & 干预措施
Reference Arm: Breastfed
Epidemiological reference group of breastfed infants.
Investigational
Infant Formula: enriched level of myelin-relevant nutrients
干预措施: Infant Formula: enriched level of myelin-relevant nutrients (Other)
Control
Infant formula: standard level of myelin-relevant nutrients
干预措施: Infant formula: standard level of myelin-relevant nutrients (Other)
结局指标
主要结局
Brain De novo myelination
时间窗: 3, 6, 12, 18, and 24 months of life
Brain magnetic resonance imaging (MRI) derived measures (volumetric anatomical imaging) \[Physiological marker, MRI\].
Infant Cognitive Development
时间窗: 6, 12, and 24 months of life
Standardized neurodevelopment test.
Infant Early Learning Assessment
时间窗: 18 and 24 months of life
Computer-based cognitive tasks.
Brain structural connectivity
时间窗: 3, 6, 12, 18, and 24 months of life
Longitudinal analysis de novo myelination and comparison between the 3 study arms De novo myelination being assessed by brain magnetic resonance imaging (MRI; multicomponent relaxometry). \[Physiological marker, MRI\].
Brain functional connectivity
时间窗: 3, 6, 12, 18, and 24 months of life
Cross-sectional analysis de novo myelination and comparison between the 3 study arms De novo myelination being assessed by brain magnetic resonance imaging (MRI; multicomponent relaxometry). \[Physiological marker, MRI\].
Infant Social Emotional Development
时间窗: 3, 6, 12, 18, and 24 months of life
Parent report questionnaire.
次要结局
- Breast milk nutrients profile(week 3, week 6, and 3 months of life)
- Sleep(3, 6, 12, 18, and 24 months of life)
- Infant dietary assessment(6, 9, 12, 18, and 24 months of life)
- Blood nutrients profile (optional)(6, 12, and 24 months of life)
- Brain structure(3, 6, 12, 18, and 24 months of life)