Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia

NCT ID: NCT06534359

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2027-06-30

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Transpyloric tube feeding

Intervention Type: OTHER

Tube feeding into the small bowel

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.

Group Type: EXPERIMENTAL

Gastric tube feeding

Intervention Type: OTHER

Tube feeding into the stomach

Interventions

Transpyloric tube feeding

Tube feeding into the small bowel

Intervention Type: OTHER

Gastric tube feeding

Tube feeding into the stomach

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Erik Allen Jensen

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford University

Palo Alto, California, United States

Site Status: NOT_YET_RECRUITING

Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status: NOT_YET_RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Erik A Jensen, MD, MSCE

Role: CONTACT

jensene@chop.edu

267-648-2720

Facility Contacts

Lawrence Prince, MD, PhD

Role: primary

Chris Nitkin, MD

Role: primary

Erik A Jensen, MD, MSCE

Role: primary

jensene@chop.edu

267-648-2720

Other Identifiers

23-021698

Identifier Type: -

Identifier Source: org_study_id