Transpyloric versus gastric feeding for premature infants with bronchopulmonary dysplasia
Pilot Trial Comparing Transpyloric to Gastric Feeding in Very Preterm Infants With Bronchopulmonary Dysplasia
This trial will see if feeding premature infants with bronchopulmonary dysplasia directly into the small intestine (transpyloric) versus into the stomach reduces reflux and episodes of low oxygen.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 1 Month to 12 Months |
| Sex | All |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Locations | 3 sites (Palo Alto, California and 2 other locations) |
| Trial ID | NCT06534359 on ClinicalTrials.gov |
What this trial studies
Premature infants with bronchopulmonary dysplasia who require positive airway pressure and full tube feedings are randomly assigned to receive either transpyloric or gastric tube feeding for two weeks. Participants undergo a 24-hour esophageal pH-multichannel intraluminal impedance (pH-MII) recording before and after the two-week feeding period to measure gastroesophageal reflux frequency and severity. The study compares changes in reflux on pH-MII and tracks clinical outcomes including episodes of hypoxemia and serious adverse events, with at least 20 ventilated infants included for endotracheal biomarker testing. No experimental drugs are given; the focus is on different feeding routes and their short-term effects on reflux and respiratory stability.
Who should consider this trial
Good fit: Infants born before 32 weeks who are now 36–65 weeks postmenstrual age with grade 1–3 BPD, on positive airway pressure, and receiving full gastric tube feedings are the intended participants.
Not a fit: Infants who recently had transpyloric feedings, are using gastric acid suppression or GI promotility drugs, have prior gastric surgery or bowel resection, or who are not on full enteral feeds are unlikely to be eligible or to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, transpyloric feeding could reduce reflux-related oxygen dips and respiratory complications, potentially helping infants spend less time on respiratory support.
How similar studies have performed: Smaller studies and clinical reports in neonatal and pediatric populations suggest transpyloric feeding can reduce reflux episodes, but randomized data specifically in BPD infants are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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: 1. 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
Where this trial is running
Palo Alto, California and 2 other locations
- Stanford University — Palo Alto, California, United States (Not_yet_recruiting)
- Children's Mercy Hospital — Kansas City, Missouri, United States (Not_yet_recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Erik A Jensen, MD, MSCE
- Email: jensene@chop.edu
- Phone: 267-648-2720
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.