Optimal Feeding Tube Dwell Time in VLBW Infants to Reduce Feeding Tube Contamination
NCT ID: NCT03728608
Last Updated: 2025-02-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
151 participants
INTERVENTIONAL
2017-05-10
2023-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
"Efficacy of Intermittent Enteral Nutrition Versus Continuous Administration in Intensive Care"
NCT05879263
Prevention of Ventilator-Associated Pneumonia by Automatic Control of the Tracheal Tube Cuff Pressure
NCT00364299
Prevention Inhalation of Bacterial by Using Endotracheal Tube Balloon Polyvinyl Chloride or Polyurethane
NCT01114022
Intubation and Extubation Over 48 Hours Mechanical Ventilation
NCT01123681
Optimizing Enteral Nutrition Regimen for Critically Ill Patients
NCT07270939
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1--Short Dwell
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 0-48 hours for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Feeding tube dwell time of 48 hours
Feeding tube dwell time of 48 hours for first 4 weeks of life.
Group 2--Long Dwell
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 7 days for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Feeding tube dwell time of 7 day
Feeding tube dwell time of 7 days for first 4 weeks of life.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Feeding tube dwell time of 48 hours
Feeding tube dwell time of 48 hours for first 4 weeks of life.
Feeding tube dwell time of 7 day
Feeding tube dwell time of 7 days for first 4 weeks of life.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* born at \< or equal to 30 weeks
* have a birthweight \< or equal to 1500 grams
* be born to a mother who is COVID Negative
* have a feeding tube placed within 24 hours of birth
* be expected to require a feeding tube for 4 weeks following birth.
Exclusion Criteria
* infants which are not expected to live
* infants will be withdrawn from the study if they require abdominal surgery for GI morbidities
30 Weeks
40 Weeks
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Nursing Research (NINR)
NIH
National Center for Advancing Translational Sciences (NCATS)
NIH
University of Florida
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Leslie Parker
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Unversity of Florida
Gainesville, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB201700398 -N-A
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.