Comparing gastric and transpyloric feeding in infants with severe bronchopulmonary dysplasia
Official title: N-of-1 Trial Comparing Prolonged Gastric Feeding to Transpyloric Feeding in Infants with Severe Bronchopulmonary Dysplasia
Run by Le Bonheur Children's Hospital · NCT06821776 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 1 Month to 1 Year |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | Le Bonheur Children's Hospital Academic / other |
| Locations | 1 site (Memphis, Tennessee) |
| Status | Recruiting |
| Started | February 5, 2025 |
| Main results expected | February 2030 |
| Study ends | February 2030 |
| Registry record updated | February 12, 2025 |
| Trial ID | NCT06821776 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Le Bonheur Children's Hospital
Memphis, Tennessee, United States Recruiting
Study contacts
- Principal investigator: Mark Weems, MD — University of Tennessee
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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IVIG for bronchopulmonary dysplasia in infants born at 28 weeks or earlier
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High-energy DHA/ARA-enriched human milk in the first 2 weeks to lower lung problems in extremely preterm babies
This trial tests whether giving DHA/ARA-enriched, fortified human milk in the first 14 days after birth helps extremely preterm infants breathe easier and have better lung function.
-
Reduced versus higher daily fluids to prevent bronchopulmonary dysplasia in very preterm babies
This tests whether giving smaller daily fluid volumes from day 8 of life (about 135 mL/kg/day) instead of larger volumes (about 165 mL/kg/day) lowers the chance of developing BPD or dying before 36 weeks in babies born before 30 weeks.
-
Using IVIG to treat bronchopulmonary dysplasia in premature infants
This study is testing if a special immune treatment called IVIG can help premature babies with breathing problems caused by bronchopulmonary dysplasia feel better.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.