NCT03307122已完成不适用
Infant Formula GI Tolerance Evaluation
Société des Produits Nestlé (SPN)16 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2017年9月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 16
- 主要终点
- Infant GI Symptom Burden
研究概览
简要总结
Prospective, double-blind, randomized study of 2 infant formulas.
详细描述
Exclusively formula-fed infants will participate in a 6-week feeding period of an infant formula. Tolerance records will be kept for 2 days at the end of the 6-week period by caregivers.
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)
入排标准
- 年龄范围
- 9 Days 至 19 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy newborn singleton infant
- •Full-term (> 37 weeks gestation)
- •Birth weight ≥ 2500 grams and ≤ 4500 grams
- •9-19 days of age on enrollment
- •Infant's mother has elected not to breastfeed prior to enrollment and infant has exclusively formula-fed for at least 3days prior to enrollment
- •Having obtained his/her legal representative's informed consent
排除标准
- •Known or suspected cow-milk allergy
- •Currently receiving a specialty infant formula (e.g. extensively hydrolyzed, amino acid-based, metabolic), or soy-based or lactose free infant formula
- •Currently not tolerating (as perceived by the caregiver) their formula
- •Currently being treated for reflux
- •Currently experiencing gastrointestinal or respiratory symptoms secondary to an on-going infection or virus (e.g. gastrointestinal infection, upper respiratory infection, flu)
- •Congenital illness or malformation that may affect infant feeding and/or growth
- •Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment
- •Receiving prescription medication (with exception of treatment for thrush or topical medications) or home remedies, herbal preparations, or rehydration fluids that might affect GI tolerance (vitamin and mineral supplements excepted).
- •Infant's family who in the Investigator's assessment cannot be expected to comply with treatment (feeding regimen).
- •Participation in another study that has not been approved as a concomitant study by Nestlé Nutrition.
结局指标
主要结局
Infant GI Symptom Burden
时间窗: 6 weeks
Study personnel will administer questionnaire
次要结局
- Length (measured in centimeters)(Enrollment and 6 weeks)
- Spit-up and/or vomiting pattern(6 weeks)
- Weight (measured in grams)(Enrollment and 6 weeks)
- Adverse events(2 weeks and 6 weeks)
- Formula intake(6 weeks)
- Stool pattern(6 weeks)
- Crying and fussing duration(6 weeks)
- Formula satisfaction questionnaire(6 weeks)
研究者
研究点 (16)
Loading locations...
相似试验
已完成
2 期
Tolerance of Infants With Cow's Milk Protein Allergy to Extensively Hydrolyzed Rice Protein or Casein Infant FormulasCow Milk Protein SensitivityToleranceGrowth FailureNCT01909661Lactalis114
已完成
不适用
Functional Evaluation of Two Infant Formula Supplemented With Probiotics Isolated From Breast MilkInfant NutritionNCT03204630Biosearch S.A.236
已完成
不适用
To Investigate Effects of a New Infant Formula in Healthy Term Chinese InfantsHealthy InfantsNCT03520764Danone Nutricia284
已完成
不适用
Feeding Tolerance EvaluationHealthyNCT02405572Société des Produits Nestlé (SPN)43
已完成
不适用
Effect of an Infant Formula With Synbiotics in Infants Born Via Caesarean SectionGut MicrobiotaNCT04991792HiPP GmbH & Co. Vertrieb KG486