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NCT06534359 · ClinicalTrials.gov registry record · NA
Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia
A NA study of Bronchopulmonary Dysplasia and Gastroesophageal Reflux, sponsored by Children's Hospital of Philadelphia.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 3
- Study locations
NCT06534359 is a NA study of Bronchopulmonary Dysplasia and Gastroesophageal Reflux that is actively recruiting participants, run by Children's Hospital of Philadelphia. The registered enrollment target is 60 participants, below the 234-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (74% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT06534359, a NA study of Bronchopulmonary Dysplasia and Gastroesophageal Reflux, is actively recruiting participants, sponsored by Children's Hospital of Philadelphia.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 3
- Study locations
Study 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.
Conditions Studied
Interventions
- OTHER Transpyloric tube feeding
- OTHER Gastric tube feeding
Study Locations (3)
California
- Stanford University - Palo Alto
Missouri
- Children's Mercy Hospital - Kansas City
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-07-15 |
| Est. Completion | 2027-06-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06534359
The ClinicalTrials.gov registry entry for NCT06534359 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 234-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (74% lower). The listed sponsor is Children's Hospital of Philadelphia, which has 431 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Bronchopulmonary Dysplasia appearing as the primary indexed condition, and to 2 interventions - of which Transpyloric tube feeding is the first listed.
NCT06534359 reports 3 study locations spanning 3 distinct geographic areas - top geographies include California, Missouri, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06534359 about?
NCT06534359 is a clinical study titled "Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia". 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 quest...
What is the current status of trial NCT06534359?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2025-07-15. Estimated completion is 2027-06-30.
What conditions does trial NCT06534359 study?
This clinical trial studies the following conditions: Bronchopulmonary Dysplasia, Gastroesophageal Reflux.
What interventions are being tested in trial NCT06534359?
The interventions under investigation include: Transpyloric tube feeding (OTHER), Gastric tube feeding (OTHER).
Who is sponsoring clinical trial NCT06534359?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06534359 being conducted?
This trial has 3 study locations across California, Missouri, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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