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

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03728608
• Other study ID #: IRB201700398 -N-A
• Secondary ID: R01NR016964-01A1
• Status: Completed
• Phase: N/A
• Start date: May 10, 2017
• Est. completion date: May 31, 2023

Study information

• Verified date: April 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: May 31, 2023
• Est. primary completion date: February 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Weeks to 40 Weeks

Eligibility

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• infants will be withdrawn from the study if they require abdominal surgery for GI morbidities

Related Conditions & MeSH terms

• Infection

Intervention

Device:
• Feeding tube dwell time of 48 hours
Feeding tube dwell time of 48 hours for first 4 weeks of life.
• Feeding tube dwell time of 7 day
Feeding tube dwell time of 7 days for first 4 weeks of life.

Locations

Country	Name	City	State
United States	Unversity of Florida	Gainesville	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Florida	National Center for Advancing Translational Sciences (NCATS), National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Gastrointestinal Inflammation - Bio Rad	The samples will be analyzed for inflammatory markers using BioRad Bio-Plex platform	up to 20 weeks
Secondary	Gastrointestinal Inflammation - S100A12	The samples will be analyzed for inflammatory markers using S100A12	up to 20 weeks
Secondary	Gastrointestinal Inflammation - Calprotectin	The samples will be analyzed for inflammatory markers using calprotectin immunoassays	up to 20 weeks