Randomized Controlled Trial of Higher-Volume Feedings in Preterm Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Weight gain
研究概览
简要总结
The primary hypothesis is that preterm infants who are less than or equal to 32 weeks gestation and weigh 1001-2500 grams at birth will have an increase in weight gain with a feeding goal of 180-200 ml/kg/day more than the commonly used feeding goal of 140-160 ml/kg/day
详细描述
The proposed trial is designed to test the primary hypothesis that in preterm infants weighing 1001-2500 grams at birth and who are less than or equal to 32 weeks gestation, feeding goals of 180-200 ml/kg/day will increase weight gain (g/k/day) from time of enrollment to discharge home or 36 weeks post-menstrual age (PMA)(whichever comes first) more than the commonly used feeding goal volume of 140-160 ml/kg/day (usual feeding goal). This is a pilot study to determine the safety of increased volumes of feedings as opposed to fortification of feedings.
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
- 1 Day 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inborn or outborn infants born at a gestational age of 32 weeks or less; Birthweight 1001-2500; Feeding volume of at least 120 ml/kg/day; Enrolled prior to 28 days of age and prior to exceeding 32 weeks
排除标准
- •Hemodynamically significant patent ductus arteriosis; History of necrotizing enterocolitis Bell Stage II or greater; Known gastrointestinal or neurologic malformations; Prior or planned enrollment into the NICHD MILK Trial; Terminal illness or decision to withhold or limit support
研究组 & 干预措施
Higher Volume Feeding Goal
Infants randomized to this group will have higher volume feeding goals of 180-200 ml/kg/day.
干预措施: Higher Volume Feeding Goal (Other)
Usual Volume Feeding Goal
Infants randomized to this group will have feeding goals of 140-160 ml/kg/day.
结局指标
主要结局
Weight gain
时间窗: baseline to average 12 weeks of age
Average change in weight between baseline and 12 weeks
次要结局
- Head circumference(baseline to average 12 weeks of age)
- Change in head circumference z score(36 weeks or discharge)
- Length(baseline to average 12 weeks of age)
- Caloric intake(36 weeks)
- Change in weight z score(36 weeks or discharge)
- Change in length z score(36 weeks or discharge)
- Mid arm circumference(baseline to average 12 weeks of age)
- Length of stay(36 weeks or discharge)
- Rates of infants less than 10th percentile for weight(36 weeks or discharge)
研究者
Colm Travers
Principal Investigator
University of Alabama at Birmingham