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

Not Applicable

Recruiting

• Conditions: Bronchopulmonary Dysplasia; Feeding Intolerance

• Registration Number: NCT06821776
• Lead Sponsor: Le Bonheur Children's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-02-05
• Study First Submitted: 2025-02-06
• Study First Submitted QC: 2025-02-06
• Last Update Submitted: 2025-02-06
• Study First Posted: 2025-02-12
• Last Update Posted: 2025-02-12
• Primary Completion: 2030-02
• Study Completion: 2030-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Respiratory Severity Score (RSS)	8 weeks	RSS (the product of mean airway pressure and oxygen fraction) will be calculated before and after each 2-week intervention block.

Trial Locations

Locations (1)

Le Bonheur Children's Hospital; 🇺🇸 Memphis, Tennessee, United States