New Infant Formula Supports Adequate Growth and Safety Study in Healthy Infants
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 主要终点
- Weight gain change measured at set intervals for first 365 days
研究概览
简要总结
The objective of the present study is to evaluate the growth, safety, and tolerance in healthy, term infants consuming a new to market infant formula (Formula A) and a commercially available infant formula (Formula B) with daily weight gain as the primary outcome. As secondary outcomes, the study will evaluate other growth parameters, tolerance, and safety.
详细描述
This is a controlled randomized parallel assignment, masked (Participant, Care Provider, Investigator, Outcomes Assessor) study. Healthy infants will be assigned an Investigational (Formula A) experimental new milk based infant formula, or an active comparator Control (Formula B) Enfamil (trademark brand name) marketed milk based infant formula. The period for the study is 365 days (52 weeks) using repeated-measures mixed model (RMMM). Anthropometry, formula intake, tolerance, and stool characteristics will be assessed. Medically confirmed adverse events will be recorded throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study is a randomized, controlled, double-blind, study of healthy term formula fed (FF) infants.
入排标准
- 年龄范围
- 1 Day 至 21 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants will be eligible to participate if they meet all of the following conditions. At birth the infant must be:
- •Only infants whose parent(s) or legal guardian(s) have decided to feed infant formula as the sole source of nutrition, will be approached for potential study enrollment
- •Healthy, term (early term/no less than 37 weeks, 0 days through late term/no greater than 41 weeks, 6 days), singleton infant
- •Have a birth weight of ≥ 2500 grams
- •At the time of the baseline/enrollment visit, infants must be:
- •Designated as healthy by a physician
- •≤21 days post-natal age (Date of Birth = Day 0)
- •Weight for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
- •Length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
- •Head circumference for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
- •Weight for length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
- •Exclusively consuming and tolerating a cow's milk infant formula at time of enrollment
- •Have parent(s) or legal guardian(s) who agree to feed the study formula to the study subject as his/her sole source of nutrition for the duration of the study
- •Have parent(s) or legal guardian(s) who have read and voluntarily signed an Informed Consent form approved by the Institutional Review Board prior to any participation in the study.
排除标准
- •Infants will be ineligible if they have any of the following conditions that are judged by a physician to interfere with the infant's normal growth, development, and/or tolerance to an infant formula:
- •Infants showing evidence of anatomic and physiologic defects of the respiratory tract, or other congenital defects (as determined by the clinician)
- •Evidence of chronic hepatic, gastrointestinal, renal, cardiac, pulmonary, or neurological diseases
- •Having a maternal history with known adverse effects on the fetus and/or the newborn infant, such as diabetes (gestational diabetes is acceptable if infant's birth weight is < 4300 g), active tuberculosis, perinatal infection,
- •Having a family history of cow's milk protein intolerance/allergy
- •Are an infant from a multiple birth (twin, triplet, etc.)
- •Mothers who smoked cigarettes
- •Mothers who used illicit drugs during pregnancy.
研究组 & 干预措施
Formula A
An experimental Infant Formula, Milk-Based Powder with Iron, for healthy term infants 0 to 12 months of age.
干预措施: Formula A (Other)
Formula B
A Commercially available Infant Formula, for healthy term infants 0 to 12 months of age (Enfamil TM, Milk-Based Powder with Iron)
干预措施: Formula B (Other)
结局指标
主要结局
Weight gain change measured at set intervals for first 365 days
时间窗: 1-21 days, 42 days, 84 days, 126 days, 180 days, 270 days, 365 days
The infants will be weighed naked while lying quietly on a calibrated electronic scale accurate to 10 grams.
次要结局
- Safety and Tolerability evaluated and recorded by parents in daily journal on stool observations at start through 365 days using VAS (Visual Analogue Scale)(Daily through 365 days)