Status:
RECRUITING
Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Bronchopulmonary Dysplasia
Gastroesophageal Reflux
Eligibility:
All Genders
1-12 years
Phase:
NA
Brief Summary
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 refl...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
July 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06534359
Start Date
July 15 2025
End Date
June 30 2027
Last Update
July 28 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford University
Palo Alto, California, United States, 94304
2
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
3
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104