NCT01561612已完成不适用
Breastfeeding Promotion RCT and Child Metabolic Syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17,046
- 试验地点
- 1
- 主要终点
- Gastrointestinal tract infection
研究概览
简要总结
The overall goal of the PROBIT study is to investigate the influence of a randomized breastfeeding promotion intervention designed to increase the duration and exclusivity of breastfeeding ("the breastfeeding promotion intervention") on the development of maternal and child health outcomes. The hypothesis is that randomization to the intervention will be associated with lower child adiposity, lower risk of asthma and atopy, improved lung function, and improved cognitive outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth at one of 34 Maternity Hospitals in Republic of Belarus
- •Breastfeeding initiated at birth, with no contraindications to breastfeeding
- •Apgar score >=5 at 5 minutes
- •Full term gestation
- •Birth weight > 2500g
排除标准
- 未提供
结局指标
主要结局
Gastrointestinal tract infection
时间窗: 12 months of age
Occurrence of 1 or more episodes of gastrointestinal tract infection
次要结局
- dental caries(6.5 years)
- asthma(6.5 and 16 years)
- Child adiposity(Throughout childhood)
- Maternal adiposity(6.5 and 11.5 years postpartum)
- lung function(16 years)
- adiponectin(age 11.5 years)
- Apo A1(Child age 11.5 years)
- cognition(6.5 and 16 years)
- vision(16 years)
- child height(throughout childhood)
- insulin(child age 11.5 years)
- Apo B(Child age 11.5 years)
- child behavior(6.5 years)
- IGF-1(Age 11.5 years)
- glucose(child age 11.5 years)
- Child blood pressure(throughout childhood)
- Child metabolic syndrome(Age 11.5 years)
- Maternal blood pressure(11.5 years postpartum)
- Respiratory tract infections(to age 12 months and throughout childhood)
- Child growth(Throughout childhood)
- Atopy(Age 6.5 years)
- Eating Attitudes(Age 11.5 years)
- Atopic Eczema(Throughout childhood)
研究者
Emily Oken
Associate Professor
Harvard Pilgrim Health Care
研究点 (1)
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