Bronchopulmonary Dysplasia, Feeding Intolerance
Conditions
Keywords
BPD
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.
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.
Sponsors
Le Bonheur Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 1 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed