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

University of Florida151 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

151

Conditions

Infection

Interventions

Feeding tube dwell time of 48 hoursDEVICE

Feeding tube dwell time of 48 hours for first 4 weeks of life.

Feeding tube dwell time of 7 dayDEVICE

Feeding tube dwell time of 7 days for first 4 weeks of life.

Eligibility

Sex: ALLMin age: 30 WeeksMax age: 40 Weeks

Medical Language ↔ Plain English

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Criteria: * infant with known congenital GI anomalies * infants which are not expected to live * infants will be withdrawn from the study if they require abdominal surgery for GI morbidities

Locations (1)

Unversity of Florida

Gainesville, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 24 hours

Secondary Outcomes

Gastrointestinal Inflammation - S100A12

The samples will be analyzed for inflammatory markers using S100A12. Values will be log10 transformed

Time frame: 4 weeks

Gastrointestinal Inflammation - Calprotectin

The samples will be analyzed for inflammatory markers using calprotectin immunoassays. Levels will be log10 transformed

Time frame: 4 weeks

Hours of Parenteral Nutrition

Time frame: 4 weeks

Days With a Central Venous Line

Time frame: 4 weeks

Length of Neonatal Intensive Care Stay

Time frame: birth until discharge from the neonatal intensive care unit

Days to Reach Full Feeds

Time frame: 4 weeks

Number of Infants With Necrotizing Enterocolitis

Time frame: 4 weeks

Number of Infants With Late Onset Sepsis

Time frame: 4 weeks

Episodes of Abdominal Distension

Time frame: 4 weeks

Data from ClinicalTrials.gov

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