NCT04013087Unknown不适用
Randomized, Double-blind, Parallel, Controlled Study to Evaluate the Safety and Nutritional Adequacy of a New Infant Formula in Healthy Term Infants
Heilongjiang Feihe Dairy Co. Ltd.3 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2019年7月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 450
- 试验地点
- 3
- 主要终点
- Rate of change in body weight (grams/day) from baseline
研究概览
简要总结
This study is a multicenter, double-blind, randomized, controlled, parallel-designed, prospective study and is intended to evaluate the nutritional adequacy and tolerance of a new study formula compared with a concurrent control formula. Approximately 450 infants will be enrolled from approximately 3 China sites. Of these infants, approximately 300 will be randomized 1:1 to receive an investigational formula or a control formula for 16weeks of feeding. The remaining approximately 150 infants will be enrolled as a breastfeeding reference group. The primary outcome measure is the rate of weight gain in g/day between baseline and 16 weeks in the test group compared to control formula group. Participants will have the option of providing stool samples at 8 weeks and 16 weeks for analysis of microbiota and metabolomics. The study period will be 16 weeks, and all infants in the 2 formula groups will receive formula free of charge for 6 months.
详细描述
Primary Objective
- Compare the rate of weight gain (in g/day) between infants receiving an investigational formula and infants receiving a control formula between at baseline (B), B+2 weeks, B+4 weeks, B+8 weeks, B+12 weeks, and B+16 weeks.
Secondary Objectives
- Compare rate of change in length (mm/day) among infants receiving an investigational formula, infants receiving a control formula, and breastfeeding infants at baseline (B), B+2 weeks, B+4 weeks, B+8 weeks, B+12 weeks, and B+16 weeks.
- Compare rate of change in head circumference (mm/day) among infants receiving an investigational formula, infants receiving a control formula and breastfeeding infants at baseline (B), B+2 weeks, B+4 weeks, B+8 weeks, B+12 weeks, and B+16 weeks.
- Evaluate and compare achieved body weight, length, and head circumference at each visit and after 16 weeks.
- Evaluate plotted raw growth data on World Health Organization standard growth charts.1
- Compare the types and incidence of adverse events among infants receiving an investigational formula, infants receiving a control formula, and breastfeeding infants.
- Compare average daily intake of formula between infants receiving an investigational formula and infants receiving a control formula.
- Compare parents' and physician's assessment of formula tolerance among infants receiving an investigational formula, infants receiving a control formula, and breastfeeding infants.
- Compare counts of Bifidobacteria and Lactobacillus species in stools of infants receiving an investigational formula, infants receiving a control formula, and breastfeeding infants.
- Compare stool short-chain fatty acid metabolites (including total SCFAs, acetic, propionic, n-butyric, iso-butyric and n-valeric acids, L-lactic acid and D-lactic acid, etc) among infants receiving an investigational formula, infants receiving a control formula, and breastfeeding infants.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Days 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •10-14 days of age at enrolment and randomization, inclusive (day of birth is considered day 0)
- •Plan to exclusively formula feed (formula groups) OR exclusively feed human milk (breastfeeding group)
- •Healthy singleton birth
- •Gestational age of 37-42 completed weeks (37 weeks 0 days through 42 weeks 6 days)
- •Birth weight of 2490g to 4200g
- •Signed informed consent obtained for infant's and mother's participation in the 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)
- •Known allergy to cow's milk protein or a well-documented family history of allergy to cow's milk protein
- •Weight at randomization is <90% of birth weight [(weight at Visit 1÷birth weight) x 100 <90%]
- •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)
- •Known head/brain disease/injury such as microcephaly, macrocephaly or others.
- •Enrollment in another interventional clinical research study while participating in this study
结局指标
主要结局
Rate of change in body weight (grams/day) from baseline
时间窗: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Rate of change in body weight (grams/day) between baseline and B+2 weeks, B+4 weeks, B+8 weeks, B+12 weeks, and B+16 weeks.
次要结局
- Percentage of regurgitation(16 weeks)
- Fecal Bifidobacteria counts(8 weeks,16 weeks)
- Achieved body length(2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks)
- Percentage of fussiness(16 weeks)
- Rate of change in body length (mm/day) from baseline(2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks)
- Percentages of infants in each group who are <10th percentile in head circumference for age.(16 weeks)
- Achieved head circumference(2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks)
- Percentage of patterns(16 weeks)
- Percentage of cramps(16 weeks)
- Stool short-chain fatty acid(8 weeks,16 weeks)
- Rate of change in head circumference (mm/day) from baseline(2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks)
- Percentages of infants in each group who are <10th percentile in weight for age.(16 weeks)
- Percentage of respiratory manifestations(16 weeks)
- Percentage of dermatologic manifestations(16 weeks)
- Achieved body weight(2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks)
- Percentages of infants in each group who are <10th percentile in length for age.(16 weeks)
- Adverse events rate(16 weeks)
- Fecal Lactobacillus counts(8 weeks,16 weeks)
- Average daily formula intake(2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks)
- Percentage of colic(16 weeks)
- Stool characteristics(16 weeks)
研究者
研究点 (3)
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