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

Le Bonheur Children's Hospital

Status: Enrolling

Conditions: Feeding Intolerance; Bronchopulmonary Dysplasia

Treatments: Procedure: Transpyloric feeding; Procedure: Gastric feeding

Study type: Interventional

Funder types: Other

Identifiers

NCT06821776

24-10394-FB

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 1 month to 1 year old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Gastric feeding

Active Comparator group

Description:

Subject will receive 2 weeks of continuous gastric feeding via a feeding tube in the stomach.

Treatment:

Procedure: Gastric feeding

Transpyloric feeding

Active Comparator group

Description:

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.

Treatment:

Procedure: Transpyloric feeding