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RECRUITING
NCT06534359
NA

Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia

Sponsor: Children's Hospital of Philadelphia

View on ClinicalTrials.gov

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

OTHER

Transpyloric tube feeding

Tube feeding into the small bowel

OTHER

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