Gastric Feeding Versus Transpyloric Feeding in Infants with Severe Bronchopulmonary Dysplasia, a Crossover Study

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
Le Bonheur Children's Hospital
Study ID
NCT06821776
Status
Recruiting
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Conditions

  • Bronchopulmonary Dysplasia
  • Feeding Intolerance

Eligibility Criteria

Sex
ALL
Age
1 Month - 1 Year
Healthy Volunteers
Not accepted

Interventions

  • Gastric feeding — PROCEDURE
    Subjects will be fed through a feeding tube that empties into the stomach.
  • Transpyloric feeding — PROCEDURE
    Subjects will be fed through a feeding tube that passes through the stomach and empties directly into the small intestine.

Study Details

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.

Key Dates

Start date
Feb 5, 2025
Status verified
Feb 2025
Primary completion
Feb 28, 2030
Completion
Feb 28, 2030

Study Design

Enrollment
25 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Respiratory Severity Score (RSS) [ Time Frame: 8 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Le Bonheur Children's HospitalMemphisTennessee38103
Mark Weems, MD
[email protected]
901-448-8400
Katie Williams
[email protected]
901-287-8400
Mark Weems, MD

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Le Bonheur Children's Hospital· Memphis, TN

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