NCT01721512已完成不适用
The Growth and Development of Breast and Formula Fed (Containing Synbiotics and LCPUFA) Term Asian Infants.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Infant weight, body length head circumference
研究概览
简要总结
Prospective cohort study of breast and formula fed infants in a suburban setting in Jakarta, Indonesia
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
- 2 Weeks 至 6 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Breast-fed:
- •Mother intends to exclusively breast-feed from birth to at least 4 months;
- •A healthy term infant with gestational age fo 37-42 weeks and birth weight greater than or equal to 2.5 kg and equal or less than 4.75 kg.
- •Formula-fed:
- •Mother is exclusively feeding infant formula milk less than or equal to 6 weeks of birth and has no prospect of breastfeeding;
- •A healthy term infant with gestational age fo 37-42 weeks and birth weight greater than or equal to 2.5 kg and equal or less than 4.75 kg;
- •Mother consents to her infant receiving trial infant formula for 12 months.
排除标准
- •Severe congenital or metabolic disease likely to affect infant feeding or infant growth.
- •Multiple birth
结局指标
主要结局
Infant weight, body length head circumference
时间窗: 12 months
Infant weight, body length head circumference at enrolment, 2 weeks, 4 weeks and monthly thereafter until 6 months, and then at 8, 10 and 12 months.
次要结局
- Gastrointestinal tolerance(6 months)
- Gut integrity(3 months)
- Developmental progress(12 months)
- Gut microflora(3 months)
- Indicators or formula tolerance(12 months)
- General health(12 months)
研究者
Prof. Agus Firmansyah, MD, Ph.D
Professor and Chief, Division of Gastrohepatology, Department of Child Health, Medical Faculty, University of Indonesia
Indonesia University
研究点 (1)
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