Improved Cognitive Outcomes Associated With Feihe HMO With DHA/ARA in Infant Formula: A Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- Bayley-III cognitive scale
研究概览
简要总结
The goal of this interventional clinical trial is to test the effectiveness of improving cognitive development in newly born infants fed with Feihe investigational formula product containing HMO, and DHA/ARA. The main question it aims to answer is:
- whether the score of Bayley-III cognitive scale (tested at the age of 12 months) of participants in the study product arm is significantly better than participants assigned in the other two arms.
240 qualified participants will be randomized to 3 arms (investigational formula, control formula, and breast-feeding) to consume assigned formula or breast-feeding for 12 months according to protocol. There will be up to 6 site visits arranged for each participant during the study, and all relevant clinical and questionnaire data, including the most important Barley-III cognitive scale data at the age of 12 months, will be captured, recorded and entered to CMTS (Clinical Management Trial System) for statistical analysis and reporting.
Researchers will compare the three arms to validate the assumption that the consumption of Feihe investigational formula product containing HMO, and DHA/ARA will improve cognitive development in newly born infants, along with physical development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Two arms of participants will be assigned masked products (investigational formula and control formula) after randomization, while the participants of breastfeeding arm will not be assigned study products.
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newborn baby, study entry before weaning (within 28 days of birth)
- •Exclusively formula fed for at least 3 days prior to study entry and plan to be exclusively formula fed during the study (formula groups) OR plan to be exclusively fed with human milk during the study (breastfeeding group).
- •Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks gestational age).
- •Birth weight of 2500g (5 lbs. 8 oz.) to 4200g (9 lbs. 4 oz.).
- •Signed informed consent obtained for infant's participation in the study.
- •Parent or guardian of the infant agrees to not enroll the infant in another interventional clinical research study while participating in this study.
排除标准
- •History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant.
- •Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion).
- •Evidence of growth problems or concern for growth.
- •Infant was born large for gestational age (LGA) (defined as birth weight-for-age exceeding 90th percentile as plotted on the growth chart provided by Feihe) from mother who was diabetic at childbirth.
- •Participant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others) and children with known head/brain disease/injury.
- •Use of probiotics/prebiotics before the study.
结局指标
主要结局
Bayley-III cognitive scale
时间窗: At the age of 12 months
Cognitive Scale of the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) is used to evaluate the cognitive development level of participants at the age of 12 months. Bayley-III contains two scoring systems of composite scores and percentile ranks. The normal range for composite scores is between 40-160 with mean at 100 and 0-99 for the percentile ranks. Higher scores mean a better outcome.
次要结局
- Height in cm(At the age of 15-28 days and 3, 6, 9, 12 months)
- Weight in grams(At the age of 15-28 days and 3, 6, 9, 12 months)
- Head circumference in cm(At the age of 15-28 days and 3, 6, 9, 12 months)
- Amount of formula intake in ml(At the age of 15-28 days and 3, 6, 9, 12 months)
- Stool Characteristics Questionnaire(At the age of 15-28 days and 3, 6 months)
- Medically-confirmed adverse events(baseline day to 12 months)