RECRUITING

Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia

Conditions

Bronchopulmonary Dysplasia Gastroesophageal Reflux

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-07-15

Study Completion:2027-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06534359

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Month to 12 Months

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
1. Birth \<32 weeks' gestation 2. Current postmenstrual age of 36-65 weeks 3. Grade 2-3 bronchopulmonary dysplasia (BPD: treatment with positive airway pressure at 36 weeks' PMA) or grade 1 BPD (treatment with ≤2L/min flow nasal cannular at 36 weeks' PMA) with subsequent need for prolonged positive airway pressure and full enteral tube feedings 4. Treatment with positive airway pressure (high flow nasal cannula, non-invasive positive airway pressure, or invasive ventilation) at enrollment	1. Transpyloric feedings received within 7d of enrollment 2. Use of a gastric acid suppression, GI promotility drug, or caffeine within 7d of enrollment 3. History of gastrostomy tube placement, gastric fundoplication, or bowel resection resulting in short gut with contraindication to transpyloric feeding 4. Plan to wean off positive airway pressure (for non-intubated subjects) or to be extubated to non-invasive support (for subjects receiving invasive ventilation) within the 2wk trial 5. Known intolerance to transpyloric feeding 6. Persistent \>20% endotracheal tube leak (for intubated subjects only) 7. Active treatment with an investigational therapy as part of another interventional trial 8. severe congenital or genetic abnormality that adversely affects GI or cardiopulmonary function

Inclusion Criteria

Exclusion Criteria

1. Birth \<32 weeks' gestation
2. Current postmenstrual age of 36-65 weeks
3. Grade 2-3 bronchopulmonary dysplasia (BPD: treatment with positive airway pressure at 36 weeks' PMA) or grade 1 BPD (treatment with ≤2L/min flow nasal cannular at 36 weeks' PMA) with subsequent need for prolonged positive airway pressure and full enteral tube feedings
4. Treatment with positive airway pressure (high flow nasal cannula, non-invasive positive airway pressure, or invasive ventilation) at enrollment

1. Transpyloric feedings received within 7d of enrollment
2. Use of a gastric acid suppression, GI promotility drug, or caffeine within 7d of enrollment
3. History of gastrostomy tube placement, gastric fundoplication, or bowel resection resulting in short gut with contraindication to transpyloric feeding
4. Plan to wean off positive airway pressure (for non-intubated subjects) or to be extubated to non-invasive support (for subjects receiving invasive ventilation) within the 2wk trial
5. Known intolerance to transpyloric feeding
6. Persistent \>20% endotracheal tube leak (for intubated subjects only)
7. Active treatment with an investigational therapy as part of another interventional trial
8. severe congenital or genetic abnormality that adversely affects GI or cardiopulmonary function

Contacts and Locations

Study Contact

Erik A Jensen, MD, MSCE

CONTACT

267-648-2720

jensene@chop.edu

Study Locations (Sites)

Stanford University

Palo Alto, California, 94304

United States

Children's Mercy Hospital

Kansas City, Missouri, 64108

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: Children's Hospital of Philadelphia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-15

Study Completion Date2027-06-30

Study Record Updates

Study Start Date2025-07-15

Study Completion Date2027-06-30

Terms related to this study

Additional Relevant MeSH Terms

Bronchopulmonary Dysplasia
Gastroesophageal Reflux