Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia
Start Date
7/15/2025
Completion Date
6/30/2027
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 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.
Eligibility Criteria
Age Range: No minimum to No maximum
Interventions
Transpyloric tube feeding
Gastric tube feeding
Conditions
Locations
Stanford University
Palo Alto, California 94304
United States
Children's Hospital Colorado
Denver, Colorado 80218
United States
Children's Mercy Hospital
Kansas City, Missouri 64108
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United States