The Effects of Time Points to Cease Parenteral Nutrition and IGF-1 on Very Low Birth Weight Infants--A Multicenter Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 416
- 试验地点
- 1
- 主要终点
- short-term length and long-term length
研究概览
简要总结
This study aims to estimate short-term and long-term effects of time points to cease parenteral nutrition on very preterm infants, such as growth; to estimate the role of insulin-like growth factor 1 in the growth.
详细描述
At present, it is unclear when to cease parenteral nutrition, the effects of cessation times on preterm infants' growth, and whether insulin-like growth factor 1 (IGF-1) has a mediation effect in the procedure that nutrients regulate the growth in preterm infants.
Therefore, a prospective cohort study was designed with the aims:
- to estimate the association between the time to cease parenteral nutrition and the growth in very low birth weight;
- to investigate the relationship between nutrient volume in parenteral nutrition and growth in very low birth weight;
- to analyze the IGF-1 mediation effect between nutrient volume and growth regulations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants with a birth weight less than 1500 grams
- •Infants admitted within 72 hours after birth
- •Infants born from July 1, 2023, to June 30, 2024
- •Written informed consent from parents or guardians
排除标准
- •Infants with congenital abnormality
- •Infants surviving <7 days after birth
结局指标
主要结局
short-term length and long-term length
时间窗: at 36 weeks' corrected age (CA), CA 3 months, CA 6 months, CA 12 months, CA 18 months, CA 24 months, 36 months' age, 48 months' age and 60 months' age
length
short-term head circumference and long-term head circumference
时间窗: at 36 weeks' corrected age (CA), CA 3 months, CA 6 months, CA 12 months, CA 18 months, CA 24 months, 36 months' age, 48 months' age and 60 months' age
head circumference
short-term weight and long-term weight
时间窗: at 36 weeks' corrected age (CA), CA 3 months, CA 6 months, CA 12 months, CA 18 months, CA 24 months, 36 months' age, 48 months' age and 60 months' age
weight
次要结局
未报告次要终点
研究者
Li Shuaijun
Postdoctor, Attending physician
Peking University