Evaluation of a New Cow's Milk Infant Formula Containing Partially Hydrolized Whey
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Growth parameters, colic and bowel movements parameters.
研究概览
简要总结
The study will be a randomized, double-blind, prospective trial. Newborn infants (enrollment age 0-14 days) will be assigned randomly to receive one of two products, provided in identical packages except for the lid color. Neither the investigators nor the parents will know which product the infant is receiving.
The infants will be monitored at study enrollment, and at 4, 8, and 12 weeks of age.
There will be two study groups, each receiving one of the following formulas:
- The new partially hydrolyzed whey formula (NF) - Materna cow's milk infant formula containing partially hydrolyzed whey protein, produced and packaged by Materna Laboratories, Maabarot.
- The currently marketed partially hydrolyzed whey formula (CF) - Nan HA, produced by Nestlé. In order to maintain blinding, the Nan HA will be repacked in packaging identical to the Materna product, except for the lid color
详细描述
The study will be a randomized, double-blind, prospective trial. Newborn infants (enrollment age 0-14 days) will be assigned randomly to receive one of two products, provided in identical packages except for the lid color. Neither the investigators nor the parents will know which product the infant is receiving.
The infants will be monitored at study enrollment, and at 4, 8, and 12 weeks of age.
There will be two study groups, each receiving one of the following formulas:
- The new partially hydrolyzed whey formula (NF) - Materna cow's milk infant formula containing partially hydrolyzed whey protein, produced and packaged by Materna Laboratories, Maabarot.
- The currently marketed partially hydrolyzed whey formula (CF) - Nan HA, produced by Nestlé. In order to maintain blinding, the Nan HA will be repacked in packaging identical to the Materna product, except for the lid color
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy term neonates whose mothers are not able or choose not to breastfeed for medical, social, or personal reasons, will be recruited
排除标准
- •Premature or low birth weight (< 2500 g).
- •Chromosomal abnormalities or congenital malformations.
- •Jaundice of more than 12 mg% and/or phototherapy.
- •Treatment with antibiotics or other drugs during the last three days or more prior to the commencement of the study.
结局指标
主要结局
Growth parameters, colic and bowel movements parameters.
时间窗: 3 months
次要结局
- Side effects(3 months)