Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia

Launched by CHILDREN'S HOSPITAL OF PHILADELPHIA · Jul 30, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to find out if feeding premature infants with bronchopulmonary dysplasia (BPD) through a transpyloric tube (which goes directly into the small intestine) is better than feeding through a gastric tube (which goes into the stomach) when it comes to reducing gastroesophageal reflux (GER), a condition where stomach contents flow back into the esophagus. The study will check if either method affects the babies' oxygen levels or leads to serious health issues, and it will also measure how often and how severely GER occurs using special monitoring.

Eligible participants are infants born before 32 weeks of pregnancy and currently aged between 36 to 65 weeks. They need to be receiving certain types of breathing support and full tube feeding at the time of enrollment. If they join the study, they will undergo some monitoring to see how severe their reflux is before starting the feeding method assigned to them for two weeks, followed by additional checks to see if their reflux has improved. Throughout the trial, the infants will be closely monitored for any health issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Birth \<32 weeks' gestation
• • 2. Current postmenstrual age of 36-65 weeks
• • 3. Grade 2-3 bronchopulmonary dysplasia (BPD: treatment with positive airway pressure at 36 weeks' PMA) or grade 1 BPD (treatment with ≤2L/min flow nasal cannular at 36 weeks' PMA) with subsequent need for prolonged positive airway pressure and full enteral tube feedings
• • 4. Treatment with positive airway pressure (high flow nasal cannula, non-invasive positive airway pressure, or invasive ventilation) at enrollment
• • (4) Full gastric tube feedings (≥100mL/kg/d) at the time of enrollment (5) Parental consent to participate
• • Note: At least 20 infants receiving invasive ventilation will be enrolled to enable endotracheal biomarker testing.
• Exclusion Criteria:
• • 1. Transpyloric feedings received within 7d of enrollment
• • 2. Use of a gastric acid suppression, GI promotility drug, or caffeine within 7d of enrollment
• • 3. History of gastrostomy tube placement, gastric fundoplication, or bowel resection resulting in short gut with contraindication to transpyloric feeding
• • 4. Plan to wean off positive airway pressure (for non-intubated subjects) or to be extubated to non-invasive support (for subjects receiving invasive ventilation) within the 2wk trial
• • 5. Known intolerance to transpyloric feeding
• • 6. Persistent \>20% endotracheal tube leak (for intubated subjects only)
• • 7. Active treatment with an investigational therapy as part of another interventional trial
• • 8. severe congenital or genetic abnormality that adversely affects GI or cardiopulmonary function