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Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia
Sponsor: Children's Hospital of Philadelphia
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.
Official title: Pilot Trial Comparing Transpyloric to Gastric Feeding in Very Preterm Infants With Bronchopulmonary Dysplasia
Key Details
Gender
All
Age Range
1 Month - 12 Months
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-07-15
Completion Date
2027-06-30
Last Updated
2025-07-28
Healthy Volunteers
No
Interventions
Transpyloric tube feeding
Tube feeding into the small bowel
Gastric tube feeding
Tube feeding into the stomach
Locations (3)
Stanford University
Palo Alto, California, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States