Recruiting

Transpyloric vs. Gastric

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT06534359

Conditions

Bronchopulmonary Dysplasia

Gastroesophageal Reflux

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

Transpyloric tube feeding

Gastric tube feeding

Study Details

Brief 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

Bronchopulmonary Dysplasia

Gastroesophageal Reflux

Study ID

NCT06534359

Start date

Jul 15, 2025

Status verified date

Jul, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Inclusion 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

(4) Full gastric tube feedings (≥100mL/kg/d) at the time of enrollment (5) Parental consent to participate

Note: At least 20 infants receiving invasive ventilation will be enrolled to enable endotracheal biomarker testing.

Exclusion Criteria:

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Transpyloric tube feeding

Nasal or oral placed feeding tube with the distal end located within the second or third portion of the duodenum. Correct placement confirmed by radiograph.

experimental: Gastric tube feeding

Nasal or oral placed feeding tube with distal end located within the stomach. Correct placement confirmed by point of care aspirate pH testing or radiograph based on local clinical standard.

Interventions

Transpyloric tube feeding

Tube feeding into the small bowel

Gastric tube feeding

Tube feeding into the stomach

Primary outcome measure

  • Proportion (%) of time per day with oxygen saturation <80% [ Time Frame: During the 2 week trial ]
  • Serious adverse events [ Time Frame: Until hospital discharge ]

Central Contacts and Locations

Central contacts

Erik A Jensen, MD, MSCE

267-648-2720jensene@stanford.edu

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Children's Hospital Colorado

Recruiting

Denver, Colorado, United States, 80218

Contacts

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Nicolas Bamat, MD, MSCE

215-300-1356bamatn@chop.edu

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2026-07-17.