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

University of Florida

Status: Completed

Conditions: Infection

Treatments: Device: Feeding tube dwell time of 7 day; Device: Feeding tube dwell time of 48 hours

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03728608

5KL2TR001429 (U.S. NIH Grant/Contract)

IRB201700398 -N-A

5R01NR016964-04 (U.S. NIH Grant/Contract)

R01NR016964-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 151 patients

Sex: All

Ages: 30 to 40 weeks old

Volunteers: No Healthy Volunteers

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• infants will be withdrawn from the study if they require abdominal surgery for GI morbidities

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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151 participants in 2 patient groups

Group 1--Short Dwell

Active Comparator group

Description:

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.

Treatment:

Device: Feeding tube dwell time of 48 hours

Group 2--Long Dwell

Active Comparator group

Description:

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.

Treatment:

Device: Feeding tube dwell time of 7 day