ISRCTN23993517已完成不适用
Study to investigate the nutritional efficacy and Acceptance/Tolerance characteristics Of an extensively hydrolyzed whey protein formula with added Synbiotics in infants (ATOS)
Danone Research B.V. (The Netherlands)0 个研究点目标入组 228 人开始时间: 2012年12月19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
- 228
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Healthy term infants (gestational age 37- 42 weeks)
- •2. 0-35 days of age
- •3. Normal birth weight dependent on gender, and week of delivery
- •4. Exclusively formula fed
- •5. Written informed consent by both parents
排除标准
- •1. Infants with the following allergic symptoms:
- •1.1. Atopic dermatitis prior to inclusion, according to the Hanifin criteria
- •1.2. Wheezing
- •2. Previous use of antibiotics and therapeutic blood components by infant prior to inclusion
- •3. Previous use of antibiotics by the mother during breastfeeding prior to inclusion
- •4. Infants with congenital abnormality or chromosomal disorder disease (such as cystic fibrosis, tuberculosis, bronchopulmonary dysplasia, tracheomalacia, tracheoesophageal fistula, major congenital heart disease, down?s syndrome)
- •5. Parental history and pre- or perinatal indications for inherited immunodeficiency syndromes.
- •6. Infants with congenital infections (Group B streptococcal disease, Hepatitis B, Toxoplasmose, Rubella, herpes, syphillis, Epstein Bar)
- •7. Infants requiring intubations or mechanical ventilation
- •8. Infants of mothers with a significant illness or disability
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