Routine Versus no Assessment of Gastric Residual Volumes in Very Low Birth Weight Infants Receiving Enteral Feeding Via Intermittent Feeding Tubes: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AdventHealth
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Days to reach full enteral feeds
研究概览
简要总结
The practice of checking gastric residuals is not evidence based. The amount of gastric residual volume (GRV) does not correlate with either feeding intolerance or development of NEC. We hypothesize that not monitoring GRV in infants with birth weights < 1,250 g, and who are being fed intermittently by gastric tube, will result in earlier attainment of full feeding. This is an unblinded randomized controlled trial where GRV will not be checked routinely in the intervention group.
详细描述
The term "gastric residuals" in neonates refers to aspiration of gastric contents before each feeding in an infant receiving enteral feeding using an intermittent feeding tube. The presence of significant gastric residual volume (GRV) (Greater than 50% of the feeding volume) is a manifestation of delayed gastrointestinal maturation in a preterm neonate. The presence of GRV and its characteristics usually delays advancement of enteral feedings in premature infants because a large volume of undigested milk usually prompts the clinicians to hold the feeding.
Advancement of early enteral nutrition is delayed or discontinued for >24 hours in nearly 75% of all extremely preterm infants. This is despite clinical evidence showing that early establishment of enteral nutrition is associated with reductions in the severity of critical illness, and long-lasting benefits on linear growth and neurodevelopmental outcomes.
The magnitude and characteristics of GRV combined with specific findings based on abdominal examinations are usually considered by clinicians in decisions to continue with the scheduled enteral feeding plan. There are no studies to establish the normal volume of gastric residuals, its characteristics and whether routinely checking for them prior to each feed prevents necrotizing enterocolitis. A recent cohort study using retrospective controls showed that not monitoring GRV is associated with earlier attainment of full feeding in very low birth weight infants. Two small randomized studies conducted outside the United States and one study conducted in the United States showed no difference in outcomes when GRV are not checked routinely in preterm infants. These studies have several drawbacks and the practice of checking GRV continues.
Study Objectives
Primary Objective/Aim/Goal/Hypothesis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Hours 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight ≤1250g
- •Gestational age of < 33 weeks
- •Expected to receive feeds via gastric tubes
排除标准
- •Death expected within 72 hours of birth
- •Major chromosomal or congenital anomaly
- •Major GI anomaly such as gastroschisis, spontaneous perforation etc.
结局指标
主要结局
Days to reach full enteral feeds
时间窗: 1 month after enrollment
Days to reach enteral feeding volume of 120ml/kg/day
次要结局
- Necrotizing enterocolitis(Until hospital discharge, an average of 2-6 months)
- weight gain(4 weeks chronological age and 36 weeks corrected gestation)
- frequency of feeding interruptions(Until full feeds are reached, usually between 2 weeks - 2 months)