N-of-1 Trial Comparing Prolonged Gastric Feeding to Transpyloric Feeding in Infants with Severe Bronchopulmonary Dysplasia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Respiratory Severity Score (RSS)
研究概览
简要总结
Hospitalized infants with severe bronchopulmonary dysplasia (BPD) and feeding intolerance will be randomized to 2 weeks of continuous gastric feeding or continuous transpyoloric feeding. Subjects will crossover after 2 weeks and receive 4 weeks of each feeding mode. Respiratory status will be assessed to determine the optimal feeding mode for each infant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients born <32 weeks' gestation
- •Currently admitted to the Le Bonheur NICU
- •Grad 2 or 3 BPD (positive pressure or intubated at 36 weeks PMA)
- •Signs of gastroesophageal reflux, chronic aspiration, or other feeding intolerance.
排除标准
- •Known gastrointestinal anomalies
- •Unable to tolerate ≥100mL/kg/day enteral feeding
- •Congenital anomalies likely to alter feeding techniques
- •Surgical feeding tube in place or expected within the next 8 weeks
- •Expected to remain hospitalized <8 weeks
研究组 & 干预措施
Gastric feeding
Subject will receive 2 weeks of continuous gastric feeding via a feeding tube in the stomach.
干预措施: Gastric feeding (Procedure)
Transpyloric feeding
Subject will receive 2 weeks of continuous transypyloric feeding via a feeding tube that passes through the stomach into the first portion of the small intestine.
干预措施: Transpyloric feeding (Procedure)
结局指标
主要结局
Respiratory Severity Score (RSS)
时间窗: 8 weeks
RSS (the product of mean airway pressure and oxygen fraction) will be calculated before and after each 2-week intervention block.
次要结局
未报告次要终点