Prolonged Minimal Enteral Nutrition Versus Slowly Advancing Enteral Nutrition in Very Low Birth Weight Infants:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 199
- 试验地点
- 2
- 主要终点
- incidence of feeding intolerance
研究概览
简要总结
Recent studies showed the benefits of early initiation and advancement enteral feeds with daily increments in preterm infants on decreasing invasive infections and early achievement of full enteral feedings. But the data on enteral feeds of extremely low birthweight infants are limited. Preterm infants especially those <1250 gr birthweight are at increased risk of developing feeding intolerance and necrotizing enterocolitis (NEC) and so the initiation and the rate of increments of enteral feeds are usually uncertain issues for neonatologists.
详细描述
Background: Recent studies showed the benefits of early initiation and advancement enteral feeds with daily increments in preterm infants on decreasing invasive infections and early achievement of full enteral feedings. But the data on enteral feeds of extremely low birthweight infants are limited. Preterm infants especially those <1250 gr birthweight are at increased risk of developing feeding intolerance and necrotizing enterocolitis and so the initiation and the rate of increments of enteral feeds are usually uncertain issues for neonatologists.
Aim: To assess the effects of two different feeding strategies in very low birth weight preterm infants with birth weight ≤1250 gr and gestational age ≤32 weeks on the incidence of feeding intolerance and time to reach full enteral feedings.
Study design: prospective randomized controlled trial comparing the effects of prolonged minimal enteral nutrition (MEN) with progressive advancing enteral feedings.
Primary outcomes: incidence of feeding intolerance and time to reach full enteral feedings sustained for 72 hours.
Secondary outcomes: incidence of NEC, sepsis, duration of hospitalization Methods: a total of 200 preterm infants with gestational age ≤32 weeks and birthweight ≤1250 gr were randomly allocated to one of the 2 feeding strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 23 Weeks 至 32 Weeks(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gestational age≤32 weeks and birthweight ≤1250 gr, and <48 hours postnatal age
排除标准
- •Major congenital and/or chromosomal anomaly, Cyanotic congenital heart disease, Asphyxiated birth with pH <7.0 and base deficit ≥16mmol/l Severe cardiopulmonary compromise or multiorgan failure Twin-twin transfusion, Those died in postnatal 5 days of age
研究组 & 干预措施
group 1
prolonged minimal enteral nutrition
干预措施: nutrition (Dietary Supplement)
group 2
slowly advancing enteral nutrition
干预措施: nutrition (Dietary Supplement)
结局指标
主要结局
incidence of feeding intolerance
时间窗: 28 days
incidence of feeding intolerance
time to reach full enteral feedings sustained for 72 hours.
时间窗: 72 hours
次要结局
未报告次要终点
