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临床试验/NL-OMON21391
NL-OMON21391已完成不适用

A randomised, controlled, double-blind trial to investigate the effects of a new infant formula on growth, tolerance and safety in healthy term infants.

Danone Research – Centre for Specialised Nutrition0 个研究点目标入组 313 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
313

研究概览

简要总结

  1. Heijning, B.v.d., et al., 51st ESPGHAN Annual Meeting. Journal of Pediatric Gastroenterology and Nutrition, 2018. 66: p. 1110-1111. 2. Breij, L.M., et al., ESPGHAN 49th ANNUAL MEETING of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition. Journal of Pediatric Gastroenterology and Nutrition, 2016. 62: p. 867-868. 3. Breij, L.M., et al., An infant formula with large, milk phospholipid-coated lipid droplets containing a mixture of dairy and vegetable lipids supports adequate growth and is well tolerated in healthy, term infants. Am J Clin Nutr, 2019. 109(3): p. 586-596.

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1. Healthy term (gestational age >= 37 1/7 and <= 42 6/7 weeks);
  • 2. Age <= 35 days (preferably as soon as possible after birth);

排除标准

  • 1. Known current or previous illnesses/conditions or intervention which could interfere with the study or its outcome parameters;
  • 2. Mother known to suffer from hepatitis B or human immunodeficiency virus (HIV) with a minimum number of formula fed infants ≤ 14 days

研究者

发起方
Danone Research – Centre for Specialised Nutrition

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