Transpyloric Feeding for Prevention of Micro-aspiration
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Tracheal aspirate pepsin A levels in ventilated preterm infants receiving transpyloric feeding and gastric feeding.
研究概览
简要总结
To determine the effect of transpyloric (TP) feeding on microaspiration and lung inflammation in ventilated preterm infants.
详细描述
Specific Aim 1): To determine the effect of TP feeding on microaspiration and lung inflammation. Hypothesis: TP feeding will reduce the microaspiration and pulmonary inflammation in ventilated preterm infants. Evaluate markers of microaspiration (pepsin A) and lung inflammation [total cell counts, nuclear factor-kB (NF-kB) activation, tumor necrosis factor-α (TNF-α), IL-1β, IL-6, IL-8, angiopoietin 2 (Ang2), high-mobility group box-1 protein (HMGB1), macrophage migration inhibitory factor (MIF) and interferon-γ (IFN-γ)] in TA samples obtained from preterm ventilated infants with and without TP feeding.
Specific Aim 2): To determine the effect of TP feeding on respiratory support. Hypothesis: TP feeding will decrease the respiratory severity score (RSS) [Fraction of inspired oxygen (FiO2) X mean airway pressure (MAP)] and number of infants requiring ventilator support. Evaluate respiratory support in preterm ventilated infants with and without TP feeding.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants with birth weight <1500 grams
- •Requiring ventilatory support
排除标准
- •Culture-proven sepsis
- •Ventilator associated pneumonia (VAP).
结局指标
主要结局
Tracheal aspirate pepsin A levels in ventilated preterm infants receiving transpyloric feeding and gastric feeding.
时间窗: 3-7 days
Difference in tracheal aspirate pepsin A levels in preterm ventilated infants receiving transpyloric feeding and gastric feeding.
次要结局
- Respiratory support in ventilated preterm infants before and transpyloric feeding.(7-14 days)
- Tracheal aspirate cytokines levels (TNF-α, IL-1β, IL-6, IL-8, Ang2, HMGB1, MIF and IFN-gamma) in ventilated preterm infants before and after transpyloric feeding.(3-7 days)
- Tracheal aspirate pepsin A levels in ventilated preterm infants before and after transpyloric feeding.(3-7 days)
- Tracheal aspirate cytokines levels (TNF-α, IL-1β, IL-6, IL-8, Ang2, HMGB1, MIF and IFN-gamma) in ventilated preterm infants receiving transpyloric feeding and gastric feeding.(3-7 days.)
- Respiratory support in ventilated preterm infants receiving transpyloric feeding and gastric feeding.(7-14 days)
研究者
Zubair Aghai
Professor of Pediatrics
Nemours Children's Clinic