NL-OMON27338尚未招募不适用
A randomized, controlled, double-blind parallel group trial to study the effects of an infant formula containing partially hydrolysed proteins on growth and tolerance in healthy term infants
FrieslandCampina0 个研究点目标入组 276 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 276
研究概览
简要总结
N/A
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Full-term infants (born at gestational age =37 weeks).
- •Healthy birthweight (according to WHO Child Growth Standards): between 2500 and 4200 g, retrieved from medical records
- •Boys and girls
- •Apparently healthy at birth and screening
- •Weight-for-age Z-score (WAZ), weight-for-length (WHZ), and length-for-age (LAZ) Z-scores at screening within the normal range according to WHO Child Growth Standards (i.e. -2 = WAZ,WHZ,LAZ = 2)
- •Age at enrolment: =28 days of age
- •Exclusively formula fed for at least 5 days prior to inclusion
- •Exclusively formula fed during the entire intervention period
- •Parents agreeing to initiate complementary feeding after finalization of the study
- •Being available for follow up until the age of approximately 3.5 months
- •Written informed consent from parent(s) and/or legal guardian(s) aged =18 years
排除标准
- •Gestational age <37 weeks
- •Birth weight <2500 g or >4200 g
- •Age at enrolment: >28 days
- •Severe acquired or congenital diseases, mental or physical disorders, including cow’s milk protein allergy, lactose intolerance and diagnosed medical conditions that are known to affect growth (i.e. GI disorders)
- •Illness at screening/inclusion
- •Incapability of parents to comply with the study protocol
- •Illiterate parents (i.e. not able to read and write in local language)
- •Participation in another clinical trial
- •Unwillingness to accept the formula supplied by the study as the only formula for their child during study participation
- •infants fed a special diet other than standard, non-hydrolysed, cow’s or goat’s milk based infant formula
研究者
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