The Association Between Human Milk Oligosaccharides (HMOs) Profiles and Growth Indicators of Infants Aged 0-4 Months. a Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Weight for Age Z score (WAZ)
研究概览
简要总结
The breastfeeding rates globally in Indonesia generally remain low with only 40% or less infants aged 6 months are exclusively breastfed. Available national data in 2018 showed the proportion of wasted in children under 5 years old was 6.7%, while 3.5% children were severely wasted. This data showed improvement compared data in 2007 and 2013. While proportion children under 2 years old with stunted and severly stunted was 29.9%. As the third most abundant group of compounds in human milk, after lactose (70 g/L) and lipids (40 g/L), human milk oligosaccharides (HMOs) never been study in Indonesia. HMOs amount and diversity influenced by non modifiable and modifiable factors. The maternal phenotypes, the α-1-2-fucosyltransferase (FUT-2) gene and the α-1-3-4-fucosyltransferase (FUT-3) gene divided the mother into secretor (Se+) and non secretor (Se-) and Le+ or Le-). Studies showed the breastfed infants of non secretor mothers secrete lower HMOs than secretor mothers. By many functions in HMOs such as prebiotic, anti infection, modulate immunity, it is thought that HMOs can influence infant growth. The hypothesis of this study is to show the associations between maternal factors (secretor gene status/FUT-2 gene, lewis gene status/FUT-3 gene, gestational age and gestational weight gain) with HMOs profiles and growth indicators of infants aged 0-4 months.
详细描述
This study is a prospective longitudinal study to analyze the association between HMOs profiles and growth indicators of infants age 0-4 months. In this longitudinal study, the human milk, anthropometry assessment and questionnaires will be collect in the 0, 2, 4 month of age. Gestational age and birth weight will be obtain from the medical status upon enrollment.
The study will be conduct in Government & Private Hospital in Jakarta between Juli - December 2020. Based on sample size calculation, the total minimal samples are 120 samples. Subjects recruitment will be based on nonprobabilistic consecutive sampling to post partum inpatient mothers in Government & Private Hospital in Jakarta between Juli - December 2020.
Study forms consist of study information, informed consent, screening form, baseline data, follow up form and laboratory result form. The tools requirements are among others Seca 728 electronic infant scale, Anthropometry Plus (AnthroPlus) Software, World Health Organization (WHO) growth velocity chart, Questionnaires, Thermometer, 15 mL polypropylene tube, Disposable gloves and vacuum bag with dry ice. The specimens obtain for this study are 15 mL venous blood for genotyping and 10 mL breast milk (0, 2, 4 month).
After obtaining clearance from Ethical Committee of the Faculty of Medicine University of Indonesia, the post partum mothers will be presented with Form A (study information form). Patients will be informed about the aim, benefits and procedures of the study. If patients agree, she will have to sign the informed consent (Form B).
Study phases consists of
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Weeks 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of 18-45 year at the time of delivery
- •Willing to breastfed at least up to 4 month
- •Singleton birth
排除标准
- •Type 1 or 2 diabetes before or during pregnancy
- •Presenting conditions that contraindicate breastfeeding
- •Congenital illness or malformation that could affect growth
- •Infants received water or any other food besides breast milk
结局指标
主要结局
Weight for Age Z score (WAZ)
时间窗: Change from baseline WAZ at 4 months.
weight-for-age z score WHO growth chart. Comparing the weight of infant with age based on WHO growth chart.
Weight velocity
时间窗: Change from baseline weight velocity at 4 months.
Comparing the infant weight gain with weight velocity chart from WHO
Weight for Length Z score (WLZ)
时间窗: Change from baseline WLZ at 4 months.
weight-for-length z score WHO growth chart. Comparing the weight of infant with length based on WHO growth chart.
次要结局
未报告次要终点
研究者
Verawati Sudarma
Principal Investigator
Indonesia University