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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR016964-01A1 | U.S. NIH Grant/Contract | View source | |
| 5KL2TR001429 | U.S. NIH Grant/Contract | View source | |
| 5R01NR016964-04 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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The study team will determine whether a decreased feeding tube dwell time will reduce feeding tube contamination
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1--Short Dwell | Active Comparator | 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. |
|
| Group 2--Long Dwell | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feeding tube dwell time of 48 hours | Device | Feeding tube dwell time of 48 hours for first 4 weeks of life. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal Inflammation - S100A12 | The samples will be analyzed for inflammatory markers using S100A12. Values will be log10 transformed | 4 weeks |
| Gastrointestinal Inflammation - Calprotectin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Parker | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unversity of Florida | Gainesville | Florida | 32611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Colony forming units | 24 hours |
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal surgery | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leslie Parker | University of Florida | 352 273 6384 | parkela@ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 15, 2024 | Feb 15, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 9, 2024 | Apr 9, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| Feeding tube dwell time of 7 day | Device | Feeding tube dwell time of 7 days for first 4 weeks of life. |
|
The samples will be analyzed for inflammatory markers using calprotectin immunoassays. Levels will be log10 transformed
| 4 weeks |
| 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 |
| Days to Reach Full Feeds | 4 weeks |
| 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 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | weeks gestation |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
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| Secondary | Gastrointestinal Inflammation - S100A12 | The samples will be analyzed for inflammatory markers using S100A12. Values will be log10 transformed | Posted | Least Squares Mean | 95% Confidence Interval | log10 mg/dL | 4 weeks |
|
|
|
| Secondary | Gastrointestinal Inflammation - Calprotectin | The samples will be analyzed for inflammatory markers using calprotectin immunoassays. Levels will be log10 transformed | Posted | Least Squares Mean | 95% Confidence Interval | log10 mg/dL | 4 weeks |
|
|
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| Secondary | Hours of Parenteral Nutrition | Posted | Mean | 95% Confidence Interval | hours | 4 weeks |
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|
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| Secondary | Days With a Central Venous Line | Posted | Mean | 95% Confidence Interval | days | 4 weeks |
|
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|
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| Secondary | Length of Neonatal Intensive Care Stay | Posted | Mean | 95% Confidence Interval | days | birth until discharge from the neonatal intensive care unit |
|
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|
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| Secondary | Days to Reach Full Feeds | Posted | Mean | 95% Confidence Interval | days | 4 weeks |
|
|
|
|
| Secondary | Number of Infants With Necrotizing Enterocolitis | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
|
| Secondary | Number of Infants With Late Onset Sepsis | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
|
| Secondary | Episodes of Abdominal Distension | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
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| Secondary | Number of Infants With a Direct Bilirubin > 2 mg/dL | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
|
| 7 |
| 76 |
| 21 |
| 76 |
| 0 |
| 76 |
| EG001 | 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. | 6 | 75 | 22 | 75 | 0 | 75 |
| necrotizing enterocolitits | Gastrointestinal disorders | Non-systematic Assessment |
|
| Late onset sepsis | Infections and infestations | Non-systematic Assessment |
|
| abdominal distension | Gastrointestinal disorders | Non-systematic Assessment |
|
| direct bilirubin greater than 2 mg/dl | Gastrointestinal disorders | Non-systematic Assessment |
|
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