Effects of Fat-soluble Vitamins Supplementation in Early Life on Common Complications and Neural Development in Very Low Birth Weight Infants
试验速览
- 阶段
- 3 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Vitamin levels
研究概览
简要总结
Vitamins A, D, and E play important roles in humans, such as vision function, immune function, bone metabolism, cell growth and differentiation and oxidation resistance. Deficiencies in these vitamins will result in a high prevalence of cardiovascular disease, infection, bone diseases, etc. Preterm infants, especially very low birth weight infants, are at risk of vitamin deficiency. Intravenous perfusion is the most common and widely used method to supply vitamins for the specific population in early life. However, the current dose of vitamin supplied by intravenous perfusion whether can meet the need of growth and development is not sure and the appropriate dose for preterm infants is still uncertain. The purpose of this study is to investigate whether current dose of fat-soluble vitamin supplementation is enough for very low birth weight infants, the safety of high dose of fat-soluble vitamin supplementation, and compare the differences of prevalence of common complications, such as bronchopulmonary dysplasia, patent ductus arteriosus, sepsis, anemia, and neural development between these two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •admitted to the neonatal intensive care unit (NICU) within 24 hours after birth
- •gestational age younger than 34 weeks
- •birth weight less than 1500 gram
- •informed consent was obtained from the infants' parents or guardians
排除标准
- •congenital malformation
- •chromosomal disease, genetic metabolic diseases
- •the infants or his/mother has abnormal thyroid function or parathyroid gland function
- •neonatal necrotizing enterocolitis, diarrhea
- •intracranial hemorrhage of 3 degrees or above
- •pulmonary hemorrhage
- •liver enzymes elevated by more than 2 times, cholestasis
- •death or discharge against medical advice
- •refuse to take part in the study
研究组 & 干预措施
High dose of fat-soluble vitamins
Fat-soluble vitamins is administered 0.5 piece/kg (equals to 1150 U/kg vitamin A，200 U/kg vitamin D, 3.2 U/kg vitamin E) intravenously every day until the baby achieve full enteral feeding (120 ml/kg), starting with the first dose within 24 hours after birth.
干预措施: High dose of fat-Soluble Vitamin (Drug)
Conventional dose of fat-soluble vitamins
Fat-soluble vitamins is administered 0.1 piece/kg (equals to 230 U/kg vitamin A，40 U/kg vitamin D, 0.64 U/kg vitamin E) intravenously every day until the baby achieve full enteral feeding (120 ml/kg), starting with the first dose within 24 hours after birth.
干预措施: Conventional dose of fat-Soluble Vitamin (Drug)
结局指标
主要结局
Vitamin levels
时间窗: within 72 hours after birth, 4~6 weeks old
Change from baseline level of vitamin A, vitamin D, and vitamin E at 4\~6 weeks
次要结局
- Complications(corrected age of 36 weeks)
- Neural development(corrected age of 40 weeks)
- Gene polymorphism in vitamin deficiency preterm infants(within 72 hours after birth, 4~6 weeks old)