RecruitingNot ApplicableNCT06534359

Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia

Pilot Trial Comparing Transpyloric to Gastric Feeding in Very Preterm Infants With Bronchopulmonary Dysplasia


Sponsor

Children's Hospital of Philadelphia

Enrollment

60 participants

Start Date

Jul 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 1 MonthMax Age: 12 Months

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Gastric tube feeding and Transpyloric tube feeding for people with bronchopulmonary dysplasia and gastroesophageal reflux. The study is currently recruiting participants at 4 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTranspyloric tube feeding

Tube feeding into the small bowel

OTHERGastric tube feeding

Tube feeding into the stomach


Locations(4)

Stanford University

Palo Alto, California, United States

Children's Hospital Colorado

Denver, Colorado, United States

Children's Mercy Hospital

Kansas City, Missouri, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

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NCT06534359


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