RecruitingNot ApplicableNCT06821776

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

N-of-1 Trial Comparing Prolonged Gastric Feeding to Transpyloric Feeding in Infants with Severe Bronchopulmonary Dysplasia


Sponsor

Le Bonheur Children's Hospital

Enrollment

25 participants

Start Date

Feb 5, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 1 MonthMax Age: 1 Year

Inclusion Criteria4

  • 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.

Exclusion Criteria5

  • Known gastrointestinal anomalies
  • Unable to tolerate ≥100mL/kg/day enteral feeding
  • Congenital anomalies likely to alter feeding techniques
  • Surgical feeding tube in place or expected within the next 8 weeks
  • Expected to remain hospitalized <8 weeks

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Interventions

PROCEDUREGastric feeding

Subjects will be fed through a feeding tube that empties into the stomach.

PROCEDURETranspyloric feeding

Subjects will be fed through a feeding tube that passes through the stomach and empties directly into the small intestine.


Locations(1)

Le Bonheur Children's Hospital

Memphis, Tennessee, United States

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NCT06821776


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