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| Name | Class |
|---|---|
| University of Kansas Medical Center | OTHER |
| American College of Radiology | OTHER |
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The overall objective of our study is to determine the clinical usefulness of BUS for NEC evaluation in diverse NICU settings.
Bowel ultrasound (BUS) for NEC evaluation is a non-invasive imaging modality that allows real-time assessment of the intestinal wall, vascular perfusion, peristalsis, and abdominal fluid. Advantages of BUS is it is non-invasive, does not have radiation, does not require special preparation before procedure, and is well tolerated even by sick preterm infants. BUS is already being used in centers that have sufficient BUS expertise as an alternative standard of care approach for evaluating NEC, but in a highly variable manner.
Standard ultrasound equipment is all that is needed for BUS. Pre-study training will be conducted for sonographers to acquire the study BUS images using standardized technique. Pre-study training of radiologists will also be conducted to standardize the interpretation of BUS findings for NEC. All BUS for NEC ordering, acquisition, and interpretation in the study will be the same as the standard workflow for any other imaging ordered in the clinical setting. All BUS performed as part of the study will not be charged to patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AXR Arm 1 | Active Comparator | Abdomen Radiograph |
|
| AXR + BUS Arm 2 | Active Comparator | Abdomen Radiograph + Bowel Ultrasound |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bowel Ultrasound | Diagnostic Test | Bowel Ultrasound |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Days to Full Enteral Feeds: Extended Rule Out Group | Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds | Within 30 days of NEC concern |
| Days to Full Enteral Feeds: Quick Rule Out Group | Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds | Within 30 days of NEC concern |
| Days to Full Enteral Feeds: NEC Ruled In | Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds | Within 30 days of NEC concern |
| Measure | Description | Time Frame |
|---|---|---|
| Days to End Bowel Rest: Extended Rule Out Group | Number of days infants were kept nil per os (without enteral feeds) following concern for NEC | within 14 days of NEC concern |
| Days to End Bowel Rest: Quick Rule Out Group |
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Inclusion Criteria
Exclusion Criteria
• Infants with major gastrointestinal anomalies such as gastroschisis or omphalocele that prevent BUS from being performed
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| Name | Affiliation | Role |
|---|---|---|
| Sherwin Chan, MD, PhD | Children's Mercy Kansas City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States | ||
| Children's Mercy Kansas City |
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Randomization was conducted by calendar month (odd months = AXR only; even months = AXR + BUS). Cross-over occurred in 31 AXR-only evaluations (also received BUS) and 3 AXR+BUS evaluations (only received AXR). A total of 169 infants underwent 199 imaging evaluations for NEC.
Conducted between Sept 2022 - Dec 2024 at two sites: Children's Mercy Hospital (Level IV NICU) and University of Kansas Medical Center (Level III NICU).
| ID | Title | Description |
|---|---|---|
| FG000 | Abdominal Radiographs Only (AXR) | Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs only (AXR) |
| FG001 | Abdominal Radiographs plus Bowel Ultrasound (AXR + BUS) | Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs plus bowel ultrasound (AXR + BUS) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Abdominal Radiographs Only (AXR) | Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs only (AXR) |
| BG001 | Abdominal Radiographs Plus Bowel Ultrasound (AXR + BUS) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Days to Full Enteral Feeds: Extended Rule Out Group | Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds | Extended Rule Out Group: Infants with clinical concern for NEC who were ultimately not diagnosed with NEC but required more than one AXR to confidently rule out the disease. Infants who crossed over to a different imaging strategy were analyzed according to the arm to which they were originally randomized, following an intention-to-treat approach. | Posted | Mean | Standard Deviation | days | Within 30 days of NEC concern |
|
Until discharge from hospital or death, up to a maximum of 180 days.
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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 | Abdominal Radiographs Only (AXR) | Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs only (AXR) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sherwin Chan | Children's Mercy Kansas City | 816-234-3273 | sschan@cmh.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 | Oct 15, 2025 | Oct 16, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Abdominal radiograph |
| Diagnostic Test |
Abdominal radiograph |
|
Number of days infants were kept nil per os (without enteral feeds) following concern for NEC
| within 14 days of NEC concern |
| Days to End Bowel Rest: NEC Ruled In | Number of days infants were kept nil per os (without enteral feeds) following concern for NEC | within 14 days of NEC concern |
| Days to End Antibiotics: Extended Rule Out | Number of days infants received antibiotic therapy initiated for NEC concern | within 14 days of NEC concern |
| Days to End Antibiotics: Quick Rule Out | Number of days infants received antibiotic therapy initiated for NEC concern | within 14 days of NEC concern |
| Days to End Antibiotics: NEC Rule In | Number of days infants received antibiotic therapy initiated for NEC concern | within 14 days of NEC concern |
| Kansas City |
| Missouri |
| 64086 |
| United States |
Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs plus bowel ultrasound (AXR + BUS)
| BG002 | Total | Total of all reporting groups |
| weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Birthweight | Mean | Standard Deviation | kg |
|
| Site - Level III or IV NICU | Count of Participants | Participants |
|
| Multiple Gestation (%) | Count of Participants | Participants |
|
| Congenital anomalies (%) | Count of Participants | Participants |
|
Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs plus bowel ultrasound (AXR + BUS) |
|
|
| Primary | Days to Full Enteral Feeds: Quick Rule Out Group | Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds | Quick Rule Out Group: Infants with suspected NEC in whom the diagnosis was excluded after a single AXR. Infants who crossed over to a different imaging strategy were analyzed according to the arm to which they were originally randomized, following an intention-to-treat approach. | Posted | Mean | Standard Deviation | days | Within 30 days of NEC concern |
|
|
|
| Primary | Days to Full Enteral Feeds: NEC Ruled In | Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds | NEC Ruled In Group: Infants with suspected NEC who were diagnosed with NEC based on clinical, laboratory, and imaging findings. Infants who crossed over to a different imaging strategy were analyzed according to the arm to which they were originally randomized, following an intention-to-treat approach. | Posted | Mean | Standard Deviation | days | Within 30 days of NEC concern |
|
|
|
| Secondary | Days to End Bowel Rest: Extended Rule Out Group | Number of days infants were kept nil per os (without enteral feeds) following concern for NEC | Extended Rule Out Group: Infants with clinical concern for NEC who were ultimately not diagnosed with NEC but required more than one AXR to confidently rule out the disease. Infants who crossed over to a different imaging strategy were analyzed according to the arm to which they were originally randomized, following an intention-to-treat approach. | Posted | Mean | Standard Deviation | days | within 14 days of NEC concern |
|
|
|
| Secondary | Days to End Bowel Rest: Quick Rule Out Group | Number of days infants were kept nil per os (without enteral feeds) following concern for NEC | Quick Rule Out Group: Infants with suspected NEC in whom the diagnosis was excluded after a single AXR. Infants who crossed over to a different imaging strategy were analyzed according to the arm to which they were originally randomized, following an intention-to-treat approach. | Posted | Mean | Standard Deviation | days | within 14 days of NEC concern |
|
|
|
| Secondary | Days to End Bowel Rest: NEC Ruled In | Number of days infants were kept nil per os (without enteral feeds) following concern for NEC | NEC Ruled In Group: Infants with suspected NEC who were diagnosed with NEC based on clinical, laboratory, and imaging findings. Infants who crossed over to a different imaging strategy were analyzed according to the arm to which they were originally randomized, following an intention-to-treat approach. | Posted | Mean | Standard Deviation | days | within 14 days of NEC concern |
|
|
|
| Secondary | Days to End Antibiotics: Extended Rule Out | Number of days infants received antibiotic therapy initiated for NEC concern | Extended Rule Out Group: Infants with clinical concern for NEC who were ultimately not diagnosed with NEC but required more than one AXR to confidently rule out the disease. Infants who crossed over to a different imaging strategy were analyzed according to the arm to which they were originally randomized, following an intention-to-treat approach. | Posted | Mean | Standard Deviation | days | within 14 days of NEC concern |
|
|
|
| Secondary | Days to End Antibiotics: Quick Rule Out | Number of days infants received antibiotic therapy initiated for NEC concern | Quick Rule Out Group: Infants with suspected NEC in whom the diagnosis was excluded after a single AXR. Infants who crossed over to a different imaging strategy were analyzed according to the arm to which they were originally randomized, following an intention-to-treat approach. | Posted | Mean | Standard Deviation | days | within 14 days of NEC concern |
|
|
|
| Secondary | Days to End Antibiotics: NEC Rule In | Number of days infants received antibiotic therapy initiated for NEC concern | NEC Ruled In Group: Infants with suspected NEC who were diagnosed with NEC based on clinical, laboratory, and imaging findings. Infants who crossed over to a different imaging strategy were analyzed according to the arm to which they were originally randomized, following an intention-to-treat approach. | Posted | Mean | Standard Deviation | days | within 14 days of NEC concern |
|
|
|
| 5 |
| 66 |
| 0 |
| 66 |
| 0 |
| 66 |
| EG001 | Abdominal Radiographs plus Bowel Ultrasound (AXR + BUS) | Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs plus bowel ultrasound (AXR + BUS) | 8 | 74 | 0 | 74 | 0 | 74 |
| EG002 | Cross-Over to AXR + BUS | Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs only (AXR) but cross-over to AXR + BUS | 1 | 26 | 0 | 26 | 0 | 26 |
| EG003 | Cross-Over to AXR only | Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs plus bowel ultrasound (AXR + BUS) but cross-over to AXR only | 0 | 3 | 0 | 3 | 0 | 3 |
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| D007410 |
| Intestinal Diseases |