Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia

Part of paid clinical trials in Palo Alto, California.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT06534359
Status
Recruiting
Apply to this trial

Conditions

  • Bronchopulmonary Dysplasia
  • Gastroesophageal Reflux

Eligibility Criteria

Sex
ALL
Age
1 Month - 12 Months
Healthy Volunteers
Not accepted

Interventions

  • Transpyloric tube feeding — OTHER
    Tube feeding into the small bowel
  • Gastric tube feeding — OTHER
    Tube feeding into the stomach

Study Details

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.

Key Dates

Start date
Jul 15, 2025
Status verified
Jul 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Proportion (%) of time per day with oxygen saturation <80% [ Time Frame: During the 2 week trial ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304
Lawrence Prince, MD, PhD
Children's Mercy HospitalKansas CityMissouri64108
Chris Nitkin, MD
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Erik A Jensen, MD, MSCE
[email protected]
267-648-2720

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By research site
Stanford University· Palo Alto, CAChildren's Mercy Hospital· Kansas City, MOChildren's Hospital of Philadelphia· Philadelphia, PA

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