Clinical trial Recruiting at 1 site Interventional Ages 1 Month to 1 Year

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.

More Bronchopulmonary Dysplasia trials

Quick facts

Study typeInterventional
Ages1 Month to 1 Year
SexAll
Enrollment25 (estimated)
SponsorLe Bonheur Children's Hospital
Academic / other
Locations1 site (Memphis, Tennessee)
StatusRecruiting
StartedFebruary 5, 2025
Main results expectedFebruary 2030
Study endsFebruary 2030
Registry record updatedFebruary 12, 2025
Trial IDNCT06821776 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.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.