Routine Aspiration of Residual Gastric Contents in Very Low Birth Weight Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Enteral Intake on Day of Life 42
研究概览
简要总结
The primary purpose of this study is to determine nutrition outcomes and risks to gastrointestinal integrity and function of aspirating for routine gastric contents prior to each feeding in very low birth weight premature infants.
详细描述
The participants in the study will be randomly assigned (like the flip of a coin) to either have the leftover food in their stomach removed before each feeding, or not have the leftover food removed before each feeding. In addition, when a blood drawn is performed as regular care an extra amount with be taken. A test to determine how much of the hormones gastrin and motilin are contained in the blood will be performed. Stool samples will be collected. Participation could last up to approximately 6 to 8 weeks of age.
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
- — 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •born at 32 weeks of less of gestational age
- •birth weight </= to 1250 grams
- •receiving some enteral feedings by 72 hours of age
- •receiving parenteral feedings by 24 hours of age
排除标准
- •Congenital or chromosomal abnormalities
- •complex congenital heart diseases and congenital anatomic gastrointestinal abnormalities
结局指标
主要结局
Enteral Intake on Day of Life 42
时间窗: Day of life 42
The volume in mL/kg of feeds provided to infants on day of life 42
Enteral Intake at Day of Life 35
时间窗: Day of life 35
The volume in mL/kg of feeds provided to infants on day of life 35
Enteral Intake on Day of Life 28
时间窗: Day of life 28
The volume in mL/kg of feeds provided to the infant on day of life 28
Enteral Intake on Day of Life 21
时间窗: Day of life 21
The volume in mL/kg of feeds provided to infants on day of life 21
Enteral Intake on Day of Life 7
时间窗: Day of life 7
The volume in mL/kg of feeds provided to infant on day of life 7
Enteral Intake on Day of Life 14
时间窗: Day of life 14
The volume in mL/kg of feeds provided to infant on day of life 7
次要结局
- Hours Receiving Parenteral Nutrition(Baseline to 42 days)
- Hours of Central Line Access(Baseline to 42 days)
- Episodes of Aspiration Pneumonia(baseline to 42 days)
- Episodes of Abdominal Distension(Baseline to 42 days)
- Head Circumference(42 days)
- Length of Hospital Stay(baseline to approximately 3 months)
- Number of Abdominal Radiographs(baseline to 42 days)
- Days to Reach Full Feeds(baseline to approximately 42 days)
- Highest Alkaline Phosphatase Level(baseline to 42 days)
- Level of Direct Bilirubin(Baseline to 42 days. highest value reported)
- Days of Invasive Ventilation(Baseline to approximately 3 months)
- Weight(42 days)
- Occurrence of Cholestasis(Baseline to 42 days)
- Episodes of Necrotizing Enterocolitis(Baseline to 42 days)
- Episodes of Bronchopulmonary Dysplasia(Baseline to approximately 3 months)
- Presence of Blood in Stools(baseline to 42 days)
- Level of Fecal Calprotectin(42 days)
- Serum Gastrin Level(baseline to 21 days)
- Fecal S100A12(42 days)
- Episodes of Late Onset Sepsis(4 to 42 days)
- Episodes of Ventilator Associated Pneumonia(baseline to 42 days)
- Episodes of a Positive Tracheal Culture(Baseline to 42 days)
- Episodes of 2 or More Positive Tracheal Aspirate Cultures(Baseline to 42 days)
- Highest Tracheal Pepsin Level(Baseline to 42 days)
- Number of Infants Who Died(Baseline to 42 days)
- Emesis(baseline to 42 days)
- Serum Motilin Level(baseline to 21 days)
- Length(42 days)