NCT03679234已完成不适用
Impact of Infant Formula on Caregiver-perceived Intolerance
Société des Produits Nestlé (SPN)14 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2018年9月24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
- 51
- 试验地点
- 14
- 主要终点
- Infant GI Symptom Burden
研究概览
简要总结
Understand the impact of switching to a commercially available infant formula on gastrointestinal symptoms
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Subjects and their parent/caregiver will be blinded to the intervention product. Care Providers at sites, Investigators, and Outcomes Assessors are unblinded to the intervention product.
入排标准
- 年龄范围
- 14 Days 至 60 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infant
- •Full-term (> 37 weeks gestation)
- •Birth weight > 2500 and < 4500 g
- •14-60 days of age on enrollment
- •Singleton birth
- •Infant's mother has elected not to breastfeed prior to enrollment
- •Infant exclusively formula-fed for at least 5 days prior to enrollment
- •Caregiver perceives infant as very or extremely fussy according to perceived fussiness based on the previous 3 days
- •Caregiver wishes to switch infant's formula
- •Has not received solid foods
- •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. thickened, extensively hydrolyzed, amino acid-based, metabolic)
- •Has switched formula more than two times since hospital discharge
- •Currently experiencing gastrointestinal or respiratory symptoms secondary to an ongoing 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 probiotic supplements
- •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: 3 weeks
Study personnel will administer questionnaire
次要结局
- Formula Intake(24 hours)
- Fussiness(24 hours)
- Formula Satisfaction Questionnaire(3 weeks)
- Adverse Events(24 hours and 3 weeks)
研究者
研究点 (14)
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