Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia (NCT06534359)
Pilot Trial Comparing Transpyloric to Gastric Feeding in Very Preterm Infants With Bronchopulmonary Dysplasia
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Stanford University — Palo Alto, California
Age range: 1 Month to 12 Months
🧪 Interventions in This Study
- Transpyloric tube feeding (OTHER)
- Gastric tube feeding (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (4 Sites)
- Stanford University — Palo Alto, California
- Children's Hospital Colorado — Denver, Colorado
- Children's Mercy Hospital — Kansas City, Missouri
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
📞 Contact the Study Coordinator
Phone: (267) 648-2720
Email: jensene@stanford.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Bronchopulmonary Dysplasia
- Enteral High-dose DHA Supplementation on Bronchopulmonary Dysplasia in Very Preterm Infants: a Collaborative Study — Québec, Quebec
- A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants — Little Rock, Arkansas
- Cellular Therapy for Extreme Preterm Infants at Risk of Developing Bronchopulmonary Dysplasia — Gloucester, Ontario
- MRI in BPD Subjects — Cincinnati, Ohio
- Ventilator Pressure and Optimization of Compliance and Hemodynamics — Birmingham, Alabama
Explore by condition: All Bronchopulmonary Dysplasia clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.