NCT04218929已完成不适用
Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ByHeart
- 入组人数
- 311
- 试验地点
- 54
- 主要终点
- Weight Gain Velocity
研究概览
简要总结
The purpose of this study is to demonstrate that a new infant formula for term infants supports age-appropriate growth. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. In this randomized, controlled trial (RCT), healthy, term, formula-fed (FF) infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants (CF) or the study formula for term infants (SF) for 16 weeks. A reference group of human milk-fed infants will also be enrolled. The primary efficacy objective is to compare the growth of infants randomized to the study infant formula (SF) versus growth of infants randomized to the standard commercial infant formula (CF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 0 Days 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Term (no less than 37 weeks, 0 days and less than 42 weeks, 0 days), singleton infant.
- •Birth weight of greater than or equal to 2500 grams.
- •Designated healthy by a physician.
- •Less than or equal to 14 days of age at enrollment.
- •If formula fed, exclusively consuming and tolerating a cow's milk infant formula at enrollment and have a parent who agrees to feed the study formula as a sole source of nutrition for a minimum of 16 weeks.
- •If human milk fed, predominantly consuming and tolerating human milk and have a mother/parent who plans to predominantly feed human milk as sole source of nutrition for a minimum of 16 weeks.
- •Weight for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
- •Length for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
- •Head circumference for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
- •Weight for length greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
- •Not currently receiving and have a parent/guardian who does not plan to give pre- and/or pro-biotics for the full duration of the study.
- •Not currently participating in an interventional clinical trial and have a parent(s) or legal guardian(s) who agree not to enroll the infant in an interventional clinical trial while participating in this trial.
- •Have parent(s) or legal guardian(s) who are capable of completing the written records, questionnaires, and study procedures required by the protocol.
- •Have a parent(s) or legal guardian(s) who have read and voluntarily signed the Institutional Review Board Informed Consent prior to study participation.
排除标准
- •Evidence of any anatomic or physiologic condition that would interfere with normal growth, development, or feeding.
- •Infants required to take medications know to influence growth and development.
- •Maternal history with known adverse effects on the fetus and/or the newborn infants.
- •Family history of cow milk protein allergy or soy intolerance/allergy.
- •Infants receiving any amount supplemental human milk with infant formula or visa-versa at time of enrollment.
- •Infants from a multiple birth.
结局指标
主要结局
Weight Gain Velocity
时间窗: 0 - 16 weeks
G/D
次要结局
- Weight for age Z-scores(0 - 16 weeks)
- 72-hr record of formula intake at each study visit(0 - 16 weeks)
- Human milk composition (concentrations of proteins, lipids, carbohydrates, vitamins, and minerals(3 weeks, 7 weeks)
- Medically-diagnosed adverse events collected throughout the study period(0 through 16 weeks)
- Parent report of infant stool frequency at each study visit(0 - 16 weeks)
- Stool metabolome(2 weeks, 16 weeks)
- Weight Measures(0 - 16 weeks)
- Head Circumference Measures(0 - 16 weeks)
- Length for age Z-scores(0 - 16 weeks)
- Blood concentrations of Interleukin-6 (pg/mL), Interleukin-10 (pg/mL), and tumor necrosis factor-alpha (pg/mL)(16 weeks)
- Blood concentrations of amino acids (umol/L)(16 weeks)
- Head circumference for age Z-scores(0 - 16 weeks)
- Length Measures(0 - 16 weeks)
- Weight for length Z-scores(0 - 16 weeks)
- Length Gain Velocity(0 - 16 weeks)
- Parent rating of infant stool consistency at each study visit(0 - 16 weeks)
- Parent report of infant disposition (fussiness, crying, gas, spit up, Infant Characteristics Questionnaire) at each study visit(0 - 16 weeks)
- Stool microbiome(2 weeks, 16 weeks)
研究者
研究点 (54)
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