N-of-1 Trial Comparing Prolonged Gastric Feeding to Transpyloric Feeding in Infants with Severe Bronchopulmonary Dysplasia
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Hospitalized infants with severe bronchopulmonary dysplasia (BPD) and feeding intolerance will be randomized to 2 weeks of continuous gastric feeding or continuous transpyoloric feeding. Subjects will crossover after 2 weeks and receive 4 weeks of each feeding mode. Respiratory status will be assessed to determine the optimal feeding mode for each infant.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 1
Healthy Volunteers: f
View:
• Patients born \<32 weeks' gestation
• Currently admitted to the Le Bonheur NICU
• Grad 2 or 3 BPD (positive pressure or intubated at 36 weeks PMA)
• Signs of gastroesophageal reflux, chronic aspiration, or other feeding intolerance.
Locations
United States
Tennessee
Le Bonheur Children's Hospital
RECRUITING
Memphis
Time Frame
Start Date: 2025-02-05
Estimated Completion Date: 2030-02
Participants
Target number of participants: 25
Treatments
Active_comparator: Gastric feeding
Subject will receive 2 weeks of continuous gastric feeding via a feeding tube in the stomach.
Active_comparator: Transpyloric feeding
Subject will receive 2 weeks of continuous transypyloric feeding via a feeding tube that passes through the stomach into the first portion of the small intestine.
Related Therapeutic Areas
Sponsors
Leads: Le Bonheur Children's Hospital