Recruiting

Gastric Feeding vs. Transpyloric Feeding

Sponsor:

Le Bonheur Children's Hospital

Code:

NCT06821776

Conditions

Bronchopulmonary Dysplasia

Feeding Intolerance

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

Gastric feeding

Transpyloric feeding

Study Details

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.

Conditions

Bronchopulmonary Dysplasia

Feeding Intolerance

Study ID

NCT06821776

Start date

Feb 5, 2025

Status verified date

Feb, 2025

Completion date

Feb, 2030

Anticipated

Primary completion date

Feb, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Gastric feeding

Subject will receive 2 weeks of continuous gastric feeding via a feeding tube in the stomach.

active comparator: Transpyloric feeding

Subject will receive 2 weeks of continuous transypyloric feeding via a feeding tube that passes through the stomach into the first portion of the small intestine.

Interventions

Gastric feeding

Subjects will be fed through a feeding tube that empties into the stomach.

Transpyloric feeding

Subjects will be fed through a feeding tube that passes through the stomach and empties directly into the small intestine.

Primary outcome measure

  • Respiratory Severity Score (RSS) [ Time Frame: 8 weeks ]

Central Contacts and Locations

Locations

Le Bonheur Children's Hospital

Recruiting

Memphis, Tennessee, United States, 38103

Contacts

Mark Weems, MD

901-448-8400mweems@uthsc.edu

Katie Williams

901-287-8400kathryn.williams@lebonheur.org

More Information

Sponsor

Le Bonheur Children's Hospital

Last update posted

Feb 12, 2025

Last verified

Feb, 2025

Keywords

  • BPD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Le Bonheur Children's Hospital on 2025-02-12.