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Optimal Feeding Tube Dwell Time in VLBW Infants to Reduce Feeding Tube Contamination

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ClinicalTrials.gov Identifier: NCT03728608
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : February 10, 2021
Sponsor:
Collaborators:
National Institute of Nursing Research (NINR)
National Center for Advancing Translational Science (NCATS)
Information provided by (Responsible Party):
University of Florida

Brief Summary:
The study team will determine whether a decreased feeding tube dwell time will reduce feeding tube contamination

Condition or disease Intervention/treatment Phase
Infection Device: Feeding tube dwell time of 48 hours Device: Feeding tube dwell time of 7 day Not Applicable

Detailed Description:
Contaminated feeding tubes can occur in the neonatal intensive care unit (NICU) and have been associated with significant morbidity. Due to an immature immunologic systems, premature infants are at significant risk of complications related to contaminated feeding tubes. Feeding tube dwell time may affect the level of contamination. This study will determine if a maximum feeding tube dwell time of 48 hours reduces contamination compared to a maximum feeding tube dwell time of 7 days, thereby improving neonatal health outcomes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Optimal Feeding Tube Dwell Time in VLBW Infants to Reduce Feeding Tube Contamination
Actual Study Start Date : May 10, 2017
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : May 31, 2022

Arm Intervention/treatment
Active Comparator: 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.
Device: Feeding tube dwell time of 48 hours
Feeding tube dwell time of 48 hours for first 4 weeks of life.

Active Comparator: 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.
Device: Feeding tube dwell time of 7 day
Feeding tube dwell time of 7 days for first 4 weeks of life.




Primary Outcome Measures :
  1. Amount of contamination [ Time Frame: 24 hours ]
    prepared solution of sectioned feeding tubes will be plated on Agar. After 24 hrs of incubation, unique colony types will be counted.


Secondary Outcome Measures :
  1. Adverse Event rate [ Time Frame: up to 20 weeks ]
    The adverse events will be recorded and monitored during the NICU stay relating to sepsis, pneumonia and feeding intolerance, and necrotizing enterocolitis

  2. Gastrointestinal inflammation - Bio Rad [ Time Frame: up to 20 weeks ]
    The samples will be analyzed for inflammatory markers using BioRad Bio-Plex platform

  3. Gastrointestinal inflammation - S100A12 [ Time Frame: up to 20 weeks ]
    The samples will be analyzed for inflammatory markers using S100A12

  4. Gastrointestinal inflammation - calprotectin [ Time Frame: up to 20 weeks ]
    The samples will be analyzed for inflammatory markers using calprotectin immunoassays



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Ages Eligible for Study:   30 Weeks to 40 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728608


Contacts
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Contact: Leslie Parker 352-273-6636 parkela@ufl.edu
Contact: Shannon Perry 352-273-6636 perrysg66@ufl.edu

Locations
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United States, Florida
Unversity of Florida Recruiting
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
National Institute of Nursing Research (NINR)
National Center for Advancing Translational Science (NCATS)
Investigators
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Principal Investigator: Leslie Parker University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03728608    
Other Study ID Numbers: IRB201700398 -N-A
R01NR016964-01A1 ( U.S. NIH Grant/Contract )
5KL2TR001429 ( U.S. NIH Grant/Contract )
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by University of Florida:
neonatal intensive care unit (NICU)
feeding tube contamination