Comparing gastric and transpyloric feeding in infants with severe bronchopulmonary dysplasia
N-of-1 Trial Comparing Prolonged Gastric Feeding to Transpyloric Feeding in Infants with Severe Bronchopulmonary Dysplasia
This study is testing whether feeding hospitalized infants with severe bronchopulmonary dysplasia through their stomach or directly into their intestines helps improve their breathing better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 1 Month to 1 Year |
| Sex | All |
| Sponsor | Le Bonheur Children's Hospital Academic / other |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT06821776 on ClinicalTrials.gov |
What this trial studies
This study involves hospitalized infants with severe bronchopulmonary dysplasia (BPD) and feeding intolerance, who will be randomized to receive either continuous gastric feeding or continuous transpyloric feeding for two weeks. After this period, the infants will crossover to the alternate feeding method for an additional four weeks. The primary focus is to assess the respiratory status of the infants to determine which feeding mode is optimal for their condition. This crossover design allows for direct comparison within the same subjects.
Who should consider this trial
Good fit: Ideal candidates are infants born before 32 weeks' gestation who are currently admitted to the Le Bonheur NICU and exhibit grade 2 or 3 BPD with feeding intolerance.
Not a fit: Patients with known gastrointestinal anomalies or those expected to remain hospitalized for less than eight weeks may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could identify the most effective feeding method to improve respiratory outcomes in infants with severe BPD.
How similar studies have performed: While there may be limited studies directly comparing these two feeding methods in this specific population, the approach of assessing feeding methods in infants with BPD has shown promise in related research.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Memphis, Tennessee
- Le Bonheur Children's Hospital — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Mark Weems, MD — University of Tennessee
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.