Optimal Feeding Tube Dwell Time in VLBW Infants to Reduce Feeding Tube Contamination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Amount of Contamination
研究概览
简要总结
The study team will determine whether a decreased feeding tube dwell time will reduce feeding tube contamination
详细描述
Contaminated feeding tubes can occur in the neonatal intensive care unit (NICU) and have been associated with significant morbidity. Due to an immature immunologic systems, premature infants are at significant risk of complications related to contaminated feeding tubes. Feeding tube dwell time may affect the level of contamination. This study will determine if a maximum feeding tube dwell time of 48 hours reduces contamination compared to a maximum feeding tube dwell time of 7 days, thereby improving neonatal health outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Weeks 至 40 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be born to a mother who is at least 18 years of age and English or Spanish speaking
- •born at < or equal to 30 weeks
- •have a birthweight < or equal to 1500 grams
- •be born to a mother who is COVID Negative
- •have a feeding tube placed within 24 hours of birth
- •be expected to require a feeding tube for 4 weeks following birth.
排除标准
- •infant with known congenital GI anomalies
- •infants which are not expected to live
- •infants will be withdrawn from the study if they require abdominal surgery for GI morbidities
研究组 & 干预措施
Group 1--Short Dwell
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 0-48 hours for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
干预措施: Feeding tube dwell time of 48 hours (Device)
Group 2--Long Dwell
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 7 days for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
干预措施: Feeding tube dwell time of 7 day (Device)
结局指标
主要结局
Amount of Contamination
时间窗: 24 hours
prepared solution of sectioned feeding tubes will be plated on Agar. After 24 hrs of incubation, unique colony types will be counted.
次要结局
- Length of Neonatal Intensive Care Stay(birth until discharge from the neonatal intensive care unit)
- Hours of Parenteral Nutrition(4 weeks)
- Days With a Central Venous Line(4 weeks)
- Days to Reach Full Feeds(4 weeks)
- Number of Infants With Necrotizing Enterocolitis(4 weeks)
- Number of Infants With Late Onset Sepsis(4 weeks)
- Gastrointestinal Inflammation - S100A12(4 weeks)
- Gastrointestinal Inflammation - Calprotectin(4 weeks)
- Episodes of Abdominal Distension(4 weeks)
- Number of Infants With a Direct Bilirubin > 2 mg/dL(4 weeks)