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

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

Detailed Description
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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.

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

Conditions
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Infection

Intervention / Treatment
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* Device: Feeding tube dwell time of 48 hours
* Device: Feeding tube dwell time of 7 day


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 Exclusion Criteria: infant with known congenital GI anomalies infants which are not expected to live infants will be withdrawn from the study if they require abdominal surgery for GI morbidities

Ages Eligible for Study
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Minimum Age: 30 Weeks
Maximum Age: 40 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1--Short Dwell<br>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<br>* Feeding tube dwell time of 48 hours for first 4 weeks of life.<br>|
| Active Comparator: Group 2--Long Dwell<br>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<br>* Feeding tube dwell time of 7 days for first 4 weeks of life.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonatal intensive care unit (NICU), feeding tube contamination