Pilot Trial Comparing Transpyloric to Gastric Feeding in Very Preterm Infants With Bronchopulmonary Dysplasia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 7
- 主要终点
- Serious adverse events
研究概览
简要总结
The goal of this clinical trial is to learn if transpyloric tube feeding (feeding directly into the small intestine) versus gastric tube feeding tolerably and effectively reduces gastroesophageal reflux in infants born premature who have been diagnosed with bronchopulmonary dysplasia. The main questions this trial aims to answer are:
Does transpyloric as compared to gastric tube feeding result in differences in the amount of experienced hypoxemia (low oxygen level in the blood) or serious adverse events?
Does transpyloric as compared to gastric tube feeding reduce the frequency and severity of gastroesophageal reflux (GER) measured using 24 hour esophageal pH-multichannel intraluminal impedance (pH-MII) monitoring?
Participants will:
Undergo pre-trial 24 hour pH-MII monitoring to determine baseline severity of GER.
Be randomly assigned to receive transpyloric or gastric tube feeding for 2 weeks.
Undergo repeat pH-MII at the end of the 2 week trial to assess for change in GER.
Undergo continuous pulse oximetry to record level of hypoxemia during the 2 week trial.
Undergo saliva and airway (if supported by a breathing tube) fluid collection to measure biomarkers of GER.
Be monitored clinically for possible adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Randomization procedures will be masked to initial pH-MII testing results.
入排标准
- 年龄范围
- 1 Month 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth <32 weeks' gestation
- •Current postmenstrual age of 36-65 weeks
- •Grade 2-3 bronchopulmonary dysplasia (BPD: treatment with positive airway pressure at 36 weeks' PMA) or grade 1 BPD (treatment with ≤2L/min flow nasal cannular at 36 weeks' PMA) with subsequent need for prolonged positive airway pressure and full enteral tube feedings
- •Treatment with positive airway pressure (high flow nasal cannula, non-invasive positive airway pressure, or invasive ventilation) at enrollment
- •(4) Full gastric tube feedings (≥100mL/kg/d) at the time of enrollment (5) Parental consent to participate
- •Note: At least 20 infants receiving invasive ventilation will be enrolled to enable endotracheal biomarker testing.
排除标准
- •Transpyloric feedings received within 7d of enrollment
- •Use of a gastric acid suppression, GI promotility drug, or caffeine within 7d of enrollment
- •History of gastrostomy tube placement, gastric fundoplication, or bowel resection resulting in short gut with contraindication to transpyloric feeding
- •Plan to wean off positive airway pressure (for non-intubated subjects) or to be extubated to non-invasive support (for subjects receiving invasive ventilation) within the 2wk trial
- •Known intolerance to transpyloric feeding
- •Persistent >20% endotracheal tube leak (for intubated subjects only)
- •Active treatment with an investigational therapy as part of another interventional trial
- •severe congenital or genetic abnormality that adversely affects GI or cardiopulmonary function
研究组 & 干预措施
Transpyloric tube feeding
Nasal or oral placed feeding tube with the distal end located within the second or third portion of the duodenum. Correct placement confirmed by radiograph.
干预措施: Transpyloric tube feeding (Other)
Gastric tube feeding
Nasal or oral placed feeding tube with distal end located within the stomach. Correct placement confirmed by point of care aspirate pH testing or radiograph based on local clinical standard.
干预措施: Gastric tube feeding (Other)
结局指标
主要结局
Serious adverse events
时间窗: Until hospital discharge
A serious adverse event (SAE) will be defined as any adverse experience that is at least possibly related to the study intervention and results in any of the following outcomes: * death, * a life-threatening event (at risk of death at the time of the event), * prolongation of existing hospitalization beyond what would be expected for a preterm infant who requires extended respiratory support near and beyond term corrected gestation, or * a persistent or significant disability/incapacity.
Proportion (%) of time per day with oxygen saturation <80%
时间窗: During the 2 week trial
Oxygen saturation will be measured by continuous pulse oximetry throughout the 2 week trial. The proportion of time per day with an oxygen saturation (SpO2) less than 80% will be calculated and reported as a median value observed over the 2 week trial.
次要结局
- Proportion of GER episodes reaching the proximal pH-MII sensor(24 hours)
- Salivary and tracheal pepsin concentration(1 day prior to initiating the trial and on trial day 7 and 14.)
- Respiratory severity score(During the 2 week trial)
- Total number of pH (acid) only reflux episodes(24 hours)
- Intermittent hypoxemic episodes(During the 2 week trial)
- Total number of gastroesophageal reflux (GER) episodes(24 hours)
- Clinically diagnosed aspiration events(During the 2 week trial)
- Total daily narcotic exposure(During the 2 week trial)
- Salivary and tracheal total bile acid concentration(1 day prior to initiating the trial and on trial day 7 and 14.)
- Prolonged hypoxemic episodes(During the 2 week trial)
- Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain scale(During the 2 week trial)
- Feeding tube replacement(During the 2 week trial)
研究者
Erik Allen Jensen
Assistant Professor of Pediatrics
Children's Hospital of Philadelphia