Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia

NCT06534359 | Recruiting DMC

• 1 other identifier: 23-021698
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (2)

• Proportion (%) of time per day with oxygen saturation <80%

  Oxygen saturation will be measured by continuous pulse oximetry throughout the 2 week trial. The proportion of time per day with an oxygen saturation (SpO2) less than 80% will be calculated and reported as a median value observed over the 2 week trial.

  During the 2 week trial

• Serious adverse events

  A serious adverse event (SAE) will be defined as any adverse experience that is at least possibly related to the study intervention and results in any of the following outcomes: * death, * a life-threatening event (at risk of death at the time of the event), * prolongation of existing hospitalization beyond what would be expected for a preterm infant who requires extended respiratory support near and beyond term corrected gestation, or * a persistent or significant disability/incapacity.

  Until hospital discharge

Secondary Outcomes (12)

• Total number of gastroesophageal reflux (GER) episodes

  24 hours

• Proportion of GER episodes reaching the proximal pH-MII sensor

  24 hours

• Total number of pH (acid) only reflux episodes

  24 hours

• Salivary and tracheal pepsin concentration

  1 day prior to initiating the trial and on trial day 7 and 14.

• Salivary and tracheal total bile acid concentration

  1 day prior to initiating the trial and on trial day 7 and 14.

Study Arms (2)

Transpyloric tube feeding

EXPERIMENTAL

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.

Other: Transpyloric tube feeding

Gastric tube feeding

EXPERIMENTAL

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.

Other: Gastric tube feeding

Interventions

Transpyloric tube feeding OTHER

Tube feeding into the small bowel

Transpyloric tube feeding

Gastric tube feeding OTHER

Tube feeding into the stomach

Gastric tube feeding

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Birth \<32 weeks' gestation
• Current postmenstrual age of 36-65 weeks
• 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
• 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.

You may not qualify if:

• Transpyloric feedings received within 7d of enrollment
• Use of a gastric acid suppression, GI promotility drug, or caffeine within 7d of enrollment
• History of gastrostomy tube placement, gastric fundoplication, or bowel resection resulting in short gut with contraindication to transpyloric feeding
• 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
• Known intolerance to transpyloric feeding
• Persistent \>20% endotracheal tube leak (for intubated subjects only)
• Active treatment with an investigational therapy as part of another interventional trial
• severe congenital or genetic abnormality that adversely affects GI or cardiopulmonary function

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (3)

Stanford University

Palo Alto, California, 94304, United States

NOT YET RECRUITING

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

NOT YET RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Gastroesophageal Reflux

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Central Study Contacts

Erik A Jensen, MD, MSCE

CONTACT

267-648-2720; jensene@chop.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Randomization procedures will be masked to initial pH-MII testing results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: July 15, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 28, 2025

Record last verified: 2025-07

Locations

US (3)