NCT03661736已完成不适用
Growth of Infants With Cow's Milk Allergy Fed an Amino Acid-based Formula Containing Two Human Milk Oligosaccharides: Comparison With World Health Organization (WHO) Growth Standards in an Observational, Single-arm Study
Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2018年4月12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
- 33
- 试验地点
- 1
- 主要终点
- The weight-for-age z-score (WAZ) compared with the WHO 2006 Child Growth Standard
研究概览
简要总结
The main aim of this study is to provide longitudinal growth data in infants with moderate-to-severe cow's milk allergy fed an amino acid-based formula with two added human milk oligosaccharides.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 8 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Full term infant (37 weeks ≤ gestation ≤ 42 weeks)
- •2500g ≤ birth weight ≤ 4500g
- •Having obtained written informed consent form the infant's parents or legally authorized representatives (LAR).
- •Infant aged between 1 and 8 months.
- •Exclusively formula-fed at time of enrolment; or CMPA infant receiving partial breastfeeding and infant's mother having independently elected before enrolment to exclusively formula feed.
- •Infants with physician-diagnosed CMPA as per standard clinical practice:
排除标准
- •Previous treatment with AAF > 72 hours
- •Known underlying medical condition that would impair growth (as per physician's assessment, e.g. unstable congenital heart disease, cystic fibrosis, metabolic disorder, chronic liver disease etc.)
- •Demonstrated chronic malabsorption which is not due to CMPA.
- •Other significant pre-natal and/or serious post-natal disease other than CMPA before enrolment (per investigator's medical decision).
- •Infants whose parents or caregivers who cannot give informed consent or who cannot be expected to comply with study procedures.
- •Treatment with systemic corticosteroids (oral or intravenous) for >72 hours within 4 weeks before enrolment (topical corticosteroids allowed)
- •Infants taking probiotic preparations for > 72 hour within 4 weeks before enrolment
- •Currently participating or having participated in another clinical trial since birth.
结局指标
主要结局
The weight-for-age z-score (WAZ) compared with the WHO 2006 Child Growth Standard
时间窗: Comparison of baseline WAZ vs WAZ at 4 months
Weight gain will be measured in kg and converted to WAZ scores
次要结局
- Length-for-age Z-scores (LAZ) compared with the WHO 2006 Child Growth Standard(1, 2, 3, 4 months from baseline and at 12 months of age)
研究者
研究点 (1)
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