Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia
Purpose
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.
Conditions
- Bronchopulmonary Dysplasia
- Gastroesophageal Reflux
Eligibility
- Eligible Ages
- Between 1 Month and 12 Months
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Birth <32 weeks' gestation 2. Current postmenstrual age of 36-65 weeks 3. 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 4. 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.
Exclusion Criteria
- Transpyloric feedings received within 7d of enrollment 2. Use of a gastric acid suppression, GI promotility drug, or caffeine within 7d of enrollment 3. History of gastrostomy tube placement, gastric fundoplication, or bowel resection resulting in short gut with contraindication to transpyloric feeding 4. 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 5. Known intolerance to transpyloric feeding 6. Persistent >20% endotracheal tube leak (for intubated subjects only) 7. Active treatment with an investigational therapy as part of another interventional trial 8. severe congenital or genetic abnormality that adversely affects GI or cardiopulmonary function
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
- Masking Description
- Randomization procedures will be masked to initial pH-MII testing results.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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. |
|
|
Experimental 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. |
|
Recruiting Locations
Palo Alto, California 94304
Denver, Colorado 80218
Philadelphia, Pennsylvania 19104
More Details
- Status
- Recruiting
- Sponsor
- Children's Hospital of Philadelphia