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

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

Study Overview

• Status: Completed
• Conditions: Infection
• Intervention / Treatment: Device: Feeding tube dwell time of 48 hours; Device: Feeding tube dwell time of 7 day

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.

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leslie Parker; Phone Number: 352-273-6636; Email: parkela@ufl.edu
• Study Contact Backup: Name: Shannon Perry; Phone Number: 352-273-6636; Email: perrysg66@ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • Unversity of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 9 months (Child)
• Accepts Healthy Volunteers: No

Description

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• infants will be withdrawn from the study if they require abdominal surgery for GI morbidities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event Rate	The adverse events will be recorded and monitored during the NICU stay relating to sepsis, pneumonia and feeding intolerance, and necrotizing enterocolitis	up to 20 weeks
Gastrointestinal Inflammation - Bio Rad	The samples will be analyzed for inflammatory markers using BioRad Bio-Plex platform	up to 20 weeks
Gastrointestinal Inflammation - S100A12	The samples will be analyzed for inflammatory markers using S100A12	up to 20 weeks
Gastrointestinal Inflammation - Calprotectin	The samples will be analyzed for inflammatory markers using calprotectin immunoassays	up to 20 weeks

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute of Nursing Research (NINR); National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Leslie Parker, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2017
• Primary Completion (Actual): February 2, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: October 24, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (Actual): November 2, 2018

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: neonatal intensive care unit (NICU); feeding tube contamination
• Other Study ID Numbers: IRB201700398 -N-A; R01NR016964-01A1 (U.S. NIH Grant/Contract); 5KL2TR001429 (U.S. NIH Grant/Contract); 5R01NR016964-04 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes