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

Not Applicable

Completed

• Conditions: Infection
• Interventions: Device: Feeding tube dwell time of 48 hours; Device: Feeding tube dwell time of 7 day

• Registration Number: NCT03728608
• Lead Sponsor: University of Florida

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-05-10
• Study First Submitted: 2018-10-24
• Study First Submitted QC: 2018-10-30
• Study First Posted: 2018-11-02
• Primary Completion: 2023-02-02
• Study Completion: 2023-05-31
• Results First Submitted: 2024-02-15
• Results First Submitted QC: 2024-02-15
• Results First Posted: 2024-03-13
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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.

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• infants will be withdrawn from the study if they require abdominal surgery for GI morbidities

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1--Short Dwell	Feeding tube dwell time of 48 hours	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.
Group 2--Long Dwell	Feeding tube dwell time of 7 day	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Gastrointestinal Inflammation - S100A12	up to 20 weeks	The samples will be analyzed for inflammatory markers using S100A12
Gastrointestinal Inflammation - Bio Rad	up to 20 weeks	The samples will be analyzed for inflammatory markers using BioRad Bio-Plex platform
Gastrointestinal Inflammation - Calprotectin	up to 20 weeks	The samples will be analyzed for inflammatory markers using calprotectin immunoassays

Trial Locations

Locations (1)

Unversity of Florida; 🇺🇸 Gainesville, Florida, United States