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临床试验/NCT01566812
NCT01566812Unknown不适用

BReast Feeding Attitude and Volume Optimization (BRAVO) Trial: A Randomized Breast Feeding Optimization Experiment

Indonesia University1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
试验地点
1
主要终点
Cardiovascular risk

研究概览

简要总结

This study aims to find out whether breast feeding optimization will increase breast feeding rates and to evaluate its effect on cardiovascular risk and general health of children.

详细描述

Breast feeding is suggested to give many benefits for babies and there are some initial prove that it might affect their future health, including the development of cardiovascular diseases. In Indonesia, breast feeding rates are very low, while there is a strong upsurge of cardiovascular disease. In this study, we propose to randomly allocate pregnant Indonesian women who plan to give breast feeding for no more than two months, to either care as usual or to a breast feeding empowerment program lasting to 6 months post partum. At the age of one year, all randomized offspring will undergo non-invasive echographic aortic vascular measurements and cardiovascular risk profiling. Measurements for assessing children's general health status will also be performed, including growth monitoring, repeated lung function test, and microbiomic sampling.

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
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Cardiovascular risk

时间窗: 5 years

Abdominal aortic/carotid intima media thickness, distensibility, elastic modulus; pulse wave velocity, stiffness index, blood pressure; echocardiography: ejection fraction (%), fractional shortening (%), TAPSE (cm), cardiac index (L/min/m2), LV mass (grams)

Breastfeeding habits

时间窗: 1 years

Breastfeeding practice: Y/N, night/day, frequency (time interval between breastfeeding, e.g 2 hours) Supplementary formula: frequency/day, volume per feeding Complementary feeding: Y/N, type of foods; frequency/day Employer and employee satisfaction

次要结局

  • Lung function(5 years)
  • Child growth(5 years)
  • Illness(1 year)
  • Microbiome(1 years)
  • Development(5 years)
  • Inflammation(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nikmah Salamia Idris

Dr.

Indonesia University

研究点 (1)

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