N/A
N=151
Optimal Feeding Tube Dwell Time in VLBW Infants to Reduce Feeding Tube Contamination
Infection
Bottom Line
View on ClinicalTrials.gov: NCT03728608 ↗Enrolled (actual)
151
Serious AEs
28.5%
Results posted
Mar 2024
Primary outcome: Primary: Amount of Contamination — 357,000,000; 4,820,000,000 Colony forming units
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Feeding tube dwell time of 48 hours (Device); Feeding tube dwell time of 7 day (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Amount of Contamination |
357,000,000; 4,820,000,000 | — |
| SECONDARY Gastrointestinal Inflammation - S100A12 |
0.87; 0.98 | — |
| SECONDARY Gastrointestinal Inflammation - Calprotectin |
2.6; 2.6 | — |
| SECONDARY Hours of Parenteral Nutrition |
195.5; 196.4 | 0.92 |
| SECONDARY Days With a Central Venous Line |
236.7; 248.3 | 0.65 |
| SECONDARY Length of Neonatal Intensive Care Stay |
75.6; 75.8 | 0.96 |
| SECONDARY Days to Reach Full Feeds |
9.3; 9.4 | 0.77 |
| SECONDARY Number of Infants With Necrotizing Enterocolitis |
4; 6 | 0.43 |
| SECONDARY Number of Infants With Late Onset Sepsis |
19; 21 | 0.97 |
| SECONDARY Episodes of Abdominal Distension |
21; 22 | 0.97 |
| SECONDARY Number of Infants With a Direct Bilirubin > 2 mg/dL |
5; 5 | 0.79 |
Summary
The study team will determine whether a decreased feeding tube dwell time will reduce feeding tube contamination
Eligibility Criteria
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- infants will be withdrawn from the study if they require abdominal surgery for GI morbidities
Data sourced from ClinicalTrials.gov (NCT03728608). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.