Using a New Human Milk Fortifier to Optimize Human Milk Feeding in Very Preterm Infants, a Multicenter Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 276
- 试验地点
- 7
- 主要终点
- Growth velocity of weight
研究概览
简要总结
This study aims to compare the safety and efficacy of a new HMF and those of other HMF used before in very preterm infants.
详细描述
Infants with fortified human milk feeding have the same rate of growth, lower incidence of nosocomial infections and feeding intolerance compared to those with formula feeding during hospitalization. However, the currently human milk fortifiers (HMF) have some nutritional components defects to meet the needs of very preterm infants. New HMF provide higher protein and fat, which are safe and well tolerate to use in preterm infants. Study on safety and efficacy of the new HMF is insufficient in Chinese preterm infant population. Our aims are to compare the safety and efficacy of a new HMF and other HMF used before in very preterm infants. Very low preterm infants with birth weights of 1000-1499g and gestational age 28+0 weeks to 31 + 6 weeks are included. Infants feeding with new HMF are in the experimental group. Infants feeding with other HMF are in the control group, a historically control group. Physical growth, nutritional indexes, incidence of feeding intolerance, and time to achieve full enteral feeding are compared between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants with gestational age between 28+0 weeks to 31+6 weeks, and 1000g≤ birth weight<1500g;
- •Delivered in the study centers or transfer to the study centers within 24 hours after birth;
- •Own mother's milk or human milk bank were available;
- •Only one of the twins is selected in this study;
- •Informed consent has been obtained.
排除标准
- •Severe congenital malformations, severe asphyxia, intracranial hemorrhage and other diseases;
- •Small for gestational age infants (birth weight below the 10th percentile of the reference, Fenton premature infant growth chart (2013)）;
- •Enteral feeding is not tolerated in 14 days after birth;
- •Infants who have participated in other clinical trials within 1 month;
- •Other conditions not suitable for this study.
结局指标
主要结局
Growth velocity of weight
时间窗: During the procedure
Weight is tested daily using the same electronic weighing scale in the different study units. Growth velocity of weight is described in g/day.
次要结局
- The change of serum potassium(The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.)
- The change of serum phosphorus(The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.)
- Incidence of apnea(During the period using HMF, an average of 30 days)
- The changes of blood hemoglobin(The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.)
- The change of serum sodium(The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.)
- Growth velocity of head circumference(During the procedure)
- Incidence of abnormal body temperature(During the period using HMF, an average of 30 days)
- Incidence of sepsis(From birth to discharge, an average of 30 days)
- Incidence of feeding intolerance(From the start day of feeding to discharge，an average of 50 days)
- Time to achieve full enteral feeding(During the hospitalization，an average of 20 days)
- The change of serum albumin(The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.)
- The Change of triglyceride.(The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.)
- Incidence of bronchopulmonary dysplasia (BPD)(From birth to discharge, an average of 40 days)
- The change of serum proalbumin(The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.)
- The changes of serum calcium(The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.)
- The change of serum alkaline phosphatase(The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.)
- The change of blood urea nitrogen(The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.)
- The changes of cholesterol(The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.)
- Incidence of abnormal heart rate(During the period using HMF, an average of 30 days)
- Incidence of necrotizing enterocolitis (NEC)(From birth to discharge, an average of 20 days)
- Incidence of retinopathy of prematurity (ROP)(From birth to discharge, an average of 40 days)