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

• Sponsor: University of Florida (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03728608
• Collaborator: National Institute of Nursing Research (NINR) (NIH), National Center for Advancing Translational Science (NCATS) (NIH), Pediatric Dermatology Res Alliance (Other), National Eczema Association (Other)
• Enrollment: 302
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 72.7
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 302 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
• Anticipated Primary Completion Date: May 31, 2023
• Anticipated Study Completion Date: May 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Amount of contamination [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 [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 [up to 20 weeks]

   The samples will be analyzed for inflammatory markers using BioRad Bio-Plex platform

3. Gastrointestinal inflammation - S100A12 [up to 20 weeks]

   The samples will be analyzed for inflammatory markers using S100A12

4. Gastrointestinal inflammation - calprotectin [up to 20 weeks]

   The samples will be analyzed for inflammatory markers using calprotectin immunoassays

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Weeks to 40 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Unversity of Florida	Gainesville	Florida	United States	32611

Sponsors and Collaborators

• University of Florida
• National Institute of Nursing Research (NINR)
• National Center for Advancing Translational Science (NCATS)
• Pediatric Dermatology Res Alliance
• National Eczema Association

Investigators

• Principal Investigator: Leslie Parker, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT03728608
• Other Study ID Numbers: IRB201700398 -N-A; R01NR016964-01A1; 5KL2TR001429; 5R01NR016964-04
• First Posted: Nov 2, 2018
• Last Update Posted: Apr 4, 2022
• Last Verified: Mar 1, 2022

• 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

Study Results

No Results Posted as of Apr 4, 2022