Transpyloric versus gastric feeding for premature infants with bronchopulmonary dysplasia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Stanford University
  Palo Alto, California, United States Recruiting
• Children's Hospital Colorado
  Denver, Colorado, United States Recruiting
• Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting
• Children's Mercy Hospital
  Kansas City, Missouri, United States Not yet recruiting

Study contacts

• Study coordinator: Erik A Jensen, MD, MSCE
• Email: jensene@stanford.edu
• Phone: 267-648-2720

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.