Necrotizing Enterocolitis
Conditions
Brief summary
The overall objective of our study is to determine the clinical usefulness of BUS for NEC evaluation in diverse NICU settings.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTBowel Ultrasound
Bowel Ultrasound
DIAGNOSTIC_TESTAbdominal radiograph
Abdominal radiograph
Sponsors
University of Kansas Medical Center
American College of Radiology
Children's Mercy Hospital Kansas City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Years
Healthy volunteers
No
Inclusion criteria
* Admitted to the NICU at CMKC or KUMC * With clinical suspicion for NEC for which further imaging evaluation was decided by treating neonatologist
Exclusion criteria
• Infants with major gastrointestinal anomalies such as gastroschisis or omphalocele that prevent BUS from being performed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days to Full Enteral Feeds: Extended Rule Out Group | Within 30 days of NEC concern | Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds |
| Days to Full Enteral Feeds: Quick Rule Out Group | Within 30 days of NEC concern | Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds |
| Days to Full Enteral Feeds: NEC Ruled In | Within 30 days of NEC concern | Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days to End Antibiotics: Extended Rule Out | within 14 days of NEC concern | Number of days infants received antibiotic therapy initiated for NEC concern |
| Days to End Bowel Rest: Extended Rule Out Group | within 14 days of NEC concern | Number of days infants were kept nil per os (without enteral feeds) following concern for NEC |
| Days to End Antibiotics: NEC Rule In | within 14 days of NEC concern | Number of days infants received antibiotic therapy initiated for NEC concern |
| Days to End Antibiotics: Quick Rule Out | within 14 days of NEC concern | Number of days infants received antibiotic therapy initiated for NEC concern |
| Days to End Bowel Rest: Quick Rule Out Group | within 14 days of NEC concern | Number of days infants were kept nil per os (without enteral feeds) following concern for NEC |
| Days to End Bowel Rest: NEC Ruled In | within 14 days of NEC concern | Number of days infants were kept nil per os (without enteral feeds) following concern for NEC |
Countries
United States
Participant flow
Recruitment details
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).
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Abdominal Radiographs Only (AXR) Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs only (AXR) | 92 |
| Abdominal Radiographs Plus Bowel Ultrasound (AXR + BUS) Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs plus bowel ultrasound (AXR + BUS) | 77 |
| Total | 169 |
Baseline characteristics
| Characteristic | Total | Abdominal Radiographs Only (AXR) | Abdominal Radiographs Plus Bowel Ultrasound (AXR + BUS) |
|---|---|---|---|
| Age, Continuous | 31 weeks STANDARD_DEVIATION 5 | 31 weeks STANDARD_DEVIATION 4.8 | 31 weeks STANDARD_DEVIATION 5.2 |
| Birthweight | 1.64 kg STANDARD_DEVIATION 0.97 | 1.63 kg STANDARD_DEVIATION 0.86 | 1.66 kg STANDARD_DEVIATION 1.1 |
| Congenital anomalies (%) | 28 Participants | 19 Participants | 9 Participants |
| Multiple Gestation (%) | 35 Participants | 18 Participants | 17 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 39 Participants | 21 Participants | 18 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 | 37 Participants | 22 Participants | 15 Participants |
| Race (NIH/OMB) White | 86 Participants | 46 Participants | 40 Participants |
| Sex: Female, Male Female | 56 Participants | 37 Participants | 19 Participants |
| Sex: Female, Male Male | 113 Participants | 55 Participants | 58 Participants |
| Site - Level III or IV NICU Level III | 64 Participants | 37 Participants | 27 Participants |
| Site - Level III or IV NICU Level IV | 105 Participants | 55 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 5 / 66 | 8 / 74 | 1 / 26 | 0 / 3 |
| other Total, other adverse events | 0 / 66 | 0 / 74 | 0 / 26 | 0 / 3 |
| serious Total, serious adverse events | 0 / 66 | 0 / 74 | 0 / 26 | 0 / 3 |
Outcome results
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
Time frame: Within 30 days of NEC concern
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abdominal Radiographs Only (AXR) | Days to Full Enteral Feeds: Extended Rule Out Group | 10.1 days | Standard Deviation 10.9 |
| Abdominal Radiographs plus Bowel Ultrasound (AXR + BUS) | Days to Full Enteral Feeds: Extended Rule Out Group | 4.9 days | Standard Deviation 4.5 |
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
Time frame: Within 30 days of NEC concern
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abdominal Radiographs Only (AXR) | Days to Full Enteral Feeds: NEC Ruled In | 17.0 days | Standard Deviation 8.6 |
| Abdominal Radiographs plus Bowel Ultrasound (AXR + BUS) | Days to Full Enteral Feeds: NEC Ruled In | 17.6 days | Standard Deviation 9 |
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
Time frame: Within 30 days of NEC concern
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abdominal Radiographs Only (AXR) | Days to Full Enteral Feeds: Quick Rule Out Group | 0.4 days | Standard Deviation 1.4 |
| Abdominal Radiographs plus Bowel Ultrasound (AXR + BUS) | Days to Full Enteral Feeds: Quick Rule Out Group | 1.0 days | Standard Deviation 2.4 |
Secondary
Days to End Antibiotics: Extended Rule Out
Number of days infants received antibiotic therapy initiated for NEC concern
Time frame: within 14 days of NEC concern
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abdominal Radiographs Only (AXR) | Days to End Antibiotics: Extended Rule Out | 1.6 days | Standard Deviation 2.3 |
| Abdominal Radiographs plus Bowel Ultrasound (AXR + BUS) | Days to End Antibiotics: Extended Rule Out | 1.5 days | Standard Deviation 2.3 |
Secondary
Days to End Antibiotics: NEC Rule In
Number of days infants received antibiotic therapy initiated for NEC concern
Time frame: within 14 days of NEC concern
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abdominal Radiographs Only (AXR) | Days to End Antibiotics: NEC Rule In | 8.4 days | Standard Deviation 4 |
| Abdominal Radiographs plus Bowel Ultrasound (AXR + BUS) | Days to End Antibiotics: NEC Rule In | 7.5 days | Standard Deviation 3.2 |
Secondary
Days to End Antibiotics: Quick Rule Out
Number of days infants received antibiotic therapy initiated for NEC concern
Time frame: within 14 days of NEC concern
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abdominal Radiographs Only (AXR) | Days to End Antibiotics: Quick Rule Out | 0.1 days | Standard Deviation 0.8 |
| Abdominal Radiographs plus Bowel Ultrasound (AXR + BUS) | Days to End Antibiotics: Quick Rule Out | 0.8 days | Standard Deviation 3.1 |
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
Time frame: within 14 days of NEC concern
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abdominal Radiographs Only (AXR) | Days to End Bowel Rest: Extended Rule Out Group | 2.6 days | Standard Deviation 2.9 |
| Abdominal Radiographs plus Bowel Ultrasound (AXR + BUS) | Days to End Bowel Rest: Extended Rule Out Group | 2.1 days | Standard Deviation 1.8 |
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
Time frame: within 14 days of NEC concern
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abdominal Radiographs Only (AXR) | Days to End Bowel Rest: NEC Ruled In | 8.7 days | Standard Deviation 4 |
| Abdominal Radiographs plus Bowel Ultrasound (AXR + BUS) | Days to End Bowel Rest: NEC Ruled In | 8.7 days | Standard Deviation 3.5 |
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
Time frame: within 14 days of NEC concern
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abdominal Radiographs Only (AXR) | Days to End Bowel Rest: Quick Rule Out Group | 0.2 days | Standard Deviation 0.6 |
| Abdominal Radiographs plus Bowel Ultrasound (AXR + BUS) | Days to End Bowel Rest: Quick Rule Out Group | 0.4 days | Standard Deviation 0.8 |