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| ID | Type | Description | Link |
|---|---|---|---|
| K23HD097254 | U.S. NIH Grant/Contract | View source | |
| IER 231718 | Other Identifier | US NIH |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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Behind the scenes pilot trial in the computer lab involving chart review to use neonatal intensive care unit data to create computer models predicting sepsis and necrotizing enterocolitis in very small premature infants
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention: Observational Cohort | Other | No Intervention: Observational Cohort |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Sepsis or Necrotizing Enterocolitis | Late-onset sepsis is defined as a positive blood culture treated with at least 5 days of antibiotics. Necrotizing enterocolitis was defined using Bell's staging criteria to include stage 2 or higher. The outcome was a binary indicator of whether either of these diagnoses was made or neither. | From 3 days of age until NICU discharge, which can occur at up to 1 year of age, and on average at 3 months old |
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Inclusion Criteria:
Exclusion Criteria:
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Neonatal intensive care patients of very low birth weight (VLBW) (<1500g)
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| Name | Affiliation | Role |
|---|---|---|
| Brynne Sullivan | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Cohort | Infants admitted to the NICU with very low birthweight (<1500g). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Cohort | Infants admitted to the NICU with very low birthweight (<1500g). |
| 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 | Number of Participants With Sepsis or Necrotizing Enterocolitis | Late-onset sepsis is defined as a positive blood culture treated with at least 5 days of antibiotics. Necrotizing enterocolitis was defined using Bell's staging criteria to include stage 2 or higher. The outcome was a binary indicator of whether either of these diagnoses was made or neither. | We analyzed data on all VLBW infants admitted to the NICU in 2024. | Posted | Count of Participants | Participants | From 3 days of age until NICU discharge, which can occur at up to 1 year of age, and on average at 3 months old |
|
From 3 days of age until NICU discharge, which can occur at up to 1 year of age, and on average at 3 months old
Adverse events were monitored/assessed in a manner that differs from the Results Data Element Definitions. "All-Cause Mortality" was not monitored/assessed; therefore 0 Participants were at Risk for All-Cause Mortality. "All anticipated and unanticipated serious adverse events" were not monitored/assessed; only those AEs deemed to be directly related to the study procedures were recorded/monitored/assessed.
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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 | Study Cohort | Infants admitted to the NICU with very low birthweight (<1500g). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brynne Sullivan | University of Virginia School of Medicine | 434- 924-5428 | bsa4m@virginia.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 | Mar 10, 2025 | Nov 3, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D020345 | Enterocolitis, Necrotizing |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | 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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| Gestational age | Mean | Standard Deviation | days |
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| Birthweight | Mean | Standard Deviation | grams |
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| Units | Counts |
|---|
| Participants |
|
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| 0 |
| 0 |
| 0 |
| 144 |
| 0 |
| 144 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |