RECRUITING

Gastric Feeding Versus Transpyloric Feeding in Infants with Severe Bronchopulmonary Dysplasia, a Crossover Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

N-of-1 Trial Comparing Prolonged Gastric Feeding to Transpyloric Feeding in Infants with Severe Bronchopulmonary Dysplasia

Quick Facts

Study Start:2025-02-05
Study Completion:2030-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06821776

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Month to 1 Year
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Patients born \<32 weeks' gestation
  2. * Currently admitted to the Le Bonheur NICU
  3. * Grad 2 or 3 BPD (positive pressure or intubated at 36 weeks PMA)
  4. * Signs of gastroesophageal reflux, chronic aspiration, or other feeding intolerance.
  1. * Known gastrointestinal anomalies
  2. * Unable to tolerate ≥100mL/kg/day enteral feeding
  3. * Congenital anomalies likely to alter feeding techniques
  4. * Surgical feeding tube in place or expected within the next 8 weeks
  5. * Expected to remain hospitalized \<8 weeks

Contacts and Locations

Principal Investigator

Mark Weems, MD
PRINCIPAL_INVESTIGATOR
University of Tennessee

Study Locations (Sites)

Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
United States

Collaborators and Investigators

Sponsor: Le Bonheur Children's Hospital

  • Mark Weems, MD, PRINCIPAL_INVESTIGATOR, University of Tennessee

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-05
Study Completion Date2030-02

Study Record Updates

Study Start Date2025-02-05
Study Completion Date2030-02

Terms related to this study

Keywords Provided by Researchers

  • BPD

Additional Relevant MeSH Terms

  • Bronchopulmonary Dysplasia
  • Feeding Intolerance