Optimal Feeding Tube Dwell Time in VLBW Infants to Reduce Feeding Tube Contamination
4 other identifiers
interventional
151
1 country
1
Brief Summary
The study team will determine whether a decreased feeding tube dwell time will reduce feeding tube contamination
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2017
CompletedFirst Submitted
Initial submission to the registry
October 24, 2018
CompletedFirst Posted
Study publicly available on registry
November 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2023
CompletedResults Posted
Study results publicly available
March 13, 2024
CompletedFebruary 3, 2025
January 1, 2025
5.7 years
October 24, 2018
February 15, 2024
January 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Amount of Contamination
prepared solution of sectioned feeding tubes will be plated on Agar. After 24 hrs of incubation, unique colony types will be counted.
24 hours
Secondary Outcomes (10)
Gastrointestinal Inflammation - S100A12
4 weeks
Gastrointestinal Inflammation - Calprotectin
4 weeks
Hours of Parenteral Nutrition
4 weeks
Days With a Central Venous Line
4 weeks
Length of Neonatal Intensive Care Stay
birth until discharge from the neonatal intensive care unit
- +5 more secondary outcomes
Study Arms (2)
Group 1--Short Dwell
ACTIVE COMPARATORPremature 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.
Group 2--Long Dwell
ACTIVE COMPARATORPremature 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.
Interventions
Feeding tube dwell time of 48 hours for first 4 weeks of life.
Feeding tube dwell time of 7 days for first 4 weeks of life.
Eligibility Criteria
You may qualify if:
- be born to a mother who is at least 18 years of age and English or Spanish speaking
- 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.
You may not qualify if:
- infant with known congenital GI anomalies
- infants which are not expected to live
- infants will be withdrawn from the study if they require abdominal surgery for GI morbidities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unversity of Florida
Gainesville, Florida, 32611, United States
MeSH Terms
Conditions
Results Point of Contact
- Title
- Leslie Parker
- Organization
- University of Florida
Study Officials
- PRINCIPAL INVESTIGATOR
Leslie Parker
University of Florida
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2018
First Posted
November 2, 2018
Study Start
May 10, 2017
Primary Completion
February 2, 2023
Study Completion
May 31, 2023
Last Updated
February 3, 2025
Results First Posted
March 13, 2024
Record last verified: 2025-01