Skip to main content
OpenTrials
Completed

NCT Number: NCT03728608

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infection Infections

Age range

30 week–40 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unversity of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • infants will be withdrawn from the study if they require abdominal surgery for GI morbidities

Treatment and study plan

Feeding tube dwell time of 48 hours

Device

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

Feeding tube dwell time of 7 day

Device

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

Primary outcomes

  1. Amount of Contamination

    Time frame: 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 outcomes

  1. Gastrointestinal Inflammation - S100A12

    Time frame: 4 weeks

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

  2. Gastrointestinal Inflammation - Calprotectin

    Time frame: 4 weeks

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

  3. Hours of Parenteral Nutrition

    Time frame: 4 weeks

  4. Days With a Central Venous Line

    Time frame: 4 weeks

  5. Length of Neonatal Intensive Care Stay

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

  6. Days to Reach Full Feeds

    Time frame: 4 weeks

  7. Number of Infants With Necrotizing Enterocolitis

    Time frame: 4 weeks

  8. Number of Infants With Late Onset Sepsis

    Time frame: 4 weeks

  9. Episodes of Abdominal Distension

    Time frame: 4 weeks

  10. Number of Infants With a Direct Bilirubin > 2 mg/dL

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Nov 2, 2018
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.