Infection
Conditions
Keywords
neonatal intensive care unit (NICU), feeding tube contamination
Brief summary
The study team will determine whether a decreased feeding tube dwell time will reduce feeding tube contamination
Detailed 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.
Interventions
DEVICEFeeding tube dwell time of 48 hours
Feeding tube dwell time of 48 hours for first 4 weeks of life.
DEVICEFeeding tube dwell time of 7 day
Feeding tube dwell time of 7 days for first 4 weeks of life.
Sponsors
National Institute of Nursing Research (NINR)
National Center for Advancing Translational Sciences (NCATS)
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Weeks to 40 Weeks
Healthy volunteers
No
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* infant with known congenital GI anomalies * infants which are not expected to live * infants will be withdrawn from the study if they require abdominal surgery for GI morbidities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Contamination | 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
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal Inflammation - Calprotectin | 4 weeks | The samples will be analyzed for inflammatory markers using calprotectin immunoassays. Levels will be log10 transformed |
| Hours of Parenteral Nutrition | 4 weeks | — |
| Days With a Central Venous Line | 4 weeks | — |
| Length of Neonatal Intensive Care Stay | birth until discharge from the neonatal intensive care unit | — |
| Gastrointestinal Inflammation - S100A12 | 4 weeks | The samples will be analyzed for inflammatory markers using S100A12. Values will be log10 transformed |
| Number of Infants With Necrotizing Enterocolitis | 4 weeks | — |
| Number of Infants With Late Onset Sepsis | 4 weeks | — |
| Episodes of Abdominal Distension | 4 weeks | — |
| Number of Infants With a Direct Bilirubin > 2 mg/dL | 4 weeks | — |
| Days to Reach Full Feeds | 4 weeks | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1--Short Dwell 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.
Feeding tube dwell time of 48 hours: Feeding tube dwell time of 48 hours for first 4 weeks of life. | 76 |
| Group 2--Long Dwell 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.
Feeding tube dwell time of 7 day: Feeding tube dwell time of 7 days for first 4 weeks of life. | 75 |
| Total | 151 |
Baseline characteristics
| Characteristic | Group 1--Short Dwell | Group 2--Long Dwell | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 76 Participants | 75 Participants | 151 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 27.8 weeks gestation STANDARD_DEVIATION 2.19 | 27.3 weeks gestation STANDARD_DEVIATION 2.2 | 27.5 weeks gestation STANDARD_DEVIATION 2.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 34 Participants | 60 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 3 Participants | 11 Participants |
| Race (NIH/OMB) White | 41 Participants | 37 Participants | 78 Participants |
| Region of Enrollment United States | 76 participants | 75 participants | 151 participants |
| Sex: Female, Male Female | 44 Participants | 40 Participants | 84 Participants |
| Sex: Female, Male Male | 32 Participants | 35 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 7 / 76 | 6 / 75 |
| other Total, other adverse events | 0 / 76 | 0 / 75 |
| serious Total, serious adverse events | 21 / 76 | 22 / 75 |
Outcome results
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.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1--Short Dwell | Amount of Contamination | 357,000,000 Colony forming units |
| Group 2--Long Dwell | Amount of Contamination | 4,820,000,000 Colony forming units |
Secondary
Days to Reach Full Feeds
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1--Short Dwell | Days to Reach Full Feeds | 9.3 days |
| Group 2--Long Dwell | Days to Reach Full Feeds | 9.4 days |
p-value: 0.77survival analysis
Secondary
Days With a Central Venous Line
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1--Short Dwell | Days With a Central Venous Line | 236.7 days |
| Group 2--Long Dwell | Days With a Central Venous Line | 248.3 days |
p-value: 0.65survival analysis
Secondary
Episodes of Abdominal Distension
Time frame: 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1--Short Dwell | Episodes of Abdominal Distension | 21 Participants |
| Group 2--Long Dwell | Episodes of Abdominal Distension | 22 Participants |
p-value: 0.97Regression, Logistic
Secondary
Gastrointestinal Inflammation - Calprotectin
The samples will be analyzed for inflammatory markers using calprotectin immunoassays. Levels will be log10 transformed
Time frame: 4 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Group 1--Short Dwell | Gastrointestinal Inflammation - Calprotectin | 2.6 log10 mg/dL |
| Group 2--Long Dwell | Gastrointestinal Inflammation - Calprotectin | 2.6 log10 mg/dL |
Secondary
Gastrointestinal Inflammation - S100A12
The samples will be analyzed for inflammatory markers using S100A12. Values will be log10 transformed
Time frame: 4 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Group 1--Short Dwell | Gastrointestinal Inflammation - S100A12 | 0.87 log10 mg/dL |
| Group 2--Long Dwell | Gastrointestinal Inflammation - S100A12 | 0.98 log10 mg/dL |
Secondary
Hours of Parenteral Nutrition
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1--Short Dwell | Hours of Parenteral Nutrition | 195.5 hours |
| Group 2--Long Dwell | Hours of Parenteral Nutrition | 196.4 hours |
p-value: 0.92survival analysis
Secondary
Length of Neonatal Intensive Care Stay
Time frame: birth until discharge from the neonatal intensive care unit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1--Short Dwell | Length of Neonatal Intensive Care Stay | 75.6 days |
| Group 2--Long Dwell | Length of Neonatal Intensive Care Stay | 75.8 days |
p-value: 0.96survival analysis
Secondary
Number of Infants With a Direct Bilirubin > 2 mg/dL
Time frame: 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1--Short Dwell | Number of Infants With a Direct Bilirubin > 2 mg/dL | 5 Participants |
| Group 2--Long Dwell | Number of Infants With a Direct Bilirubin > 2 mg/dL | 5 Participants |
p-value: 0.79Regression, Logistic
Secondary
Number of Infants With Late Onset Sepsis
Time frame: 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1--Short Dwell | Number of Infants With Late Onset Sepsis | 19 Participants |
| Group 2--Long Dwell | Number of Infants With Late Onset Sepsis | 21 Participants |
p-value: 0.97Regression, Logistic
Secondary
Number of Infants With Necrotizing Enterocolitis
Time frame: 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1--Short Dwell | Number of Infants With Necrotizing Enterocolitis | 4 Participants |
| Group 2--Long Dwell | Number of Infants With Necrotizing Enterocolitis | 6 Participants |
p-value: 0.43Regression, Logistic