NCT02016586已完成不适用
Breastfeeding Intervention Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 18
- 主要终点
- Breastfeeding Rate
研究概览
简要总结
To evaluate the benefits of a lactation support intervention, in conjunction with maternal nutritional supplementation.
详细描述
This study aims to evaluate the benefits of a lactation support intervention model combining a maternal nutritional supplementation starting at 8 weeks before delivery to 12 weeks postpartum and a lactation support intervention consisting of 1 prenatal and 3 postnatal sessions on exclusive breastfeeding rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Mother with singleton pregnancy at 26 to 29 weeks of gestation.
- •Mother is between 20 and 35 years of age.
- •Mother pre-pregnant BMI < 25.0 kg/m
- •Mother is first-time mother.
- •Mother is contactable by telephone.
- •Mother is non-smoker.
- •Infant is a singleton from a full term birth with a gestational age of 37-42 weeks.
- •Infant's birth weight was > 2500 g.
- •Infant is judged to be in good health.
- •Mother confirms her intention to breastfeed and refrain from taking any other nonstudy maternal milk supplement or galactogogues during the study period.
排除标准
- •Mother is allergic or intolerant to any ingredient found in the study product.
- •An adverse maternal, fetal or infant medical history that has potential effects on child's growth and/or development.
- •Mother has gestational diabetes and/or pre-eclampsia.
- •Mother with contraindications to breastfeeding.
- •Gestational weight gain is greater than 14 kg at enrollment.
- •Mother had a breast surgery.
- •Mother and/or newborn infant has major illness that requires intensive care admission.
- •Infant has major congenital anomaly.
结局指标
主要结局
Breastfeeding Rate
时间窗: Week 12 postpartum
次要结局
- Lactation Assessment(Week 12 postpartum)
- Infant Anthropometrics(Week 12 postpartum)
- Breastfeeding Rate(Week 8 postpartum)
研究者
研究点 (18)
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