Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia

Официальное название

Pilot Trial Comparing Transpyloric to Gastric Feeding in Very Preterm Infants With Bronchopulmonary Dysplasia

Обзор

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.

Вмешательства

• Другое Transpyloric tube feeding
  Tube feeding into the small bowel
• Другое Gastric tube feeding
  Tube feeding into the stomach

Первичные конечные точки

• Proportion (%) of time per day with oxygen saturation <80% [Срок оценки: During the 2 week trial]
• Serious adverse events [Срок оценки: Until hospital discharge]

Вторичные конечные точки (12)

• Total number of gastroesophageal reflux (GER) episodes [Срок оценки: 24 hours]
• Proportion of GER episodes reaching the proximal pH-MII sensor [Срок оценки: 24 hours]
• Total number of pH (acid) only reflux episodes [Срок оценки: 24 hours]
• Salivary and tracheal pepsin concentration [Срок оценки: 1 day prior to initiating the trial and on trial day 7 and 14.]
• Salivary and tracheal total bile acid concentration [Срок оценки: 1 day prior to initiating the trial and on trial day 7 and 14.]
• Intermittent hypoxemic episodes [Срок оценки: During the 2 week trial]
• Prolonged hypoxemic episodes [Срок оценки: During the 2 week trial]
• Clinically diagnosed aspiration events [Срок оценки: During the 2 week trial]
• Respiratory severity score [Срок оценки: During the 2 week trial]
• Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain scale [Срок оценки: During the 2 week trial]
• Total daily narcotic exposure [Срок оценки: During the 2 week trial]
• Feeding tube replacement [Срок оценки: During the 2 week trial]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 4 центра

• Stanford University — Palo Alto
• Children's Hospital Colorado — Denver
• Children's Mercy Hospital — Kansas City
• Children's Hospital of Philadelphia — Philadelphia

Идентификаторы

NCT: NCT06534359 · 24-022805 · 1R21HD113897-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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