Evaluation of Gastric Residuals in Preterm Newborns: What Impact Does It Have on Feedings Progression?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- Time to reach full feeds
研究概览
简要总结
This study evaluates the utility of measuring gastric residuals in premature infants born between 26+0 and 33+6 weeks and to determine if its routine use is related with a delay in feedings advancement in this babies compared with no measurement.
详细描述
The evaluation of gastric residuals as a measure of enteral tolerance in term and especially preterm newborns is a widely used practice in different centers worldwide. However, until now, it continues to be a controversial practice, since its real usefulness is not clear.
Our study proposes to evaluate and compare two groups of preterm newborns born between 26 + 0/7 and 33 + 6/7 weeks, randomized to measure or not measure gastric residuals and determine if this practice delays the full feeding achievement.
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
- 1 Hour 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants born between 26+0 to 33+6 weeks post-menstrual gestational age.
- •Enteral feeds starting during the first week of life.
- •Signed informed consent from parents or guardians.
排除标准
- •Perinatal asphyxia
- •Sepsis and hemodynamic instability
- •Major congenital malformations
- •Surgical requirement during the first week of life
- •Hemodynamic instability and vasoactive drugs requirement
- •Moderate or severe respiratory failure with Oxygenation Index > 8
研究组 & 干预措施
Routine aspiration of gastric residuals
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
干预措施: Aspiration of gastric residuals (Procedure)
No aspiration of gastric residuals
Infants will not have routine aspiration of gastric contents prior to each feeding.
结局指标
主要结局
Time to reach full feeds
时间窗: Baseline to 8 weeks
Time in days to reach full feeds defined as receiving 150 ml/kg/day tolerated for at least 24 hrs.
次要结局
未报告次要终点