Abdominal Injuries, Accidental Fall, Motor Vehicle Injury, Physical Abuse
Conditions
Brief summary
The purpose of the study is to generate pilot data describing test characteristics of contrast enhanced ultrasound in young children with concern for abdominal trauma. The primary objective in this study is to determine the sensitivity and specificity of contrast-enhanced ultrasound (CEUS) compared to abdominal Computed Tomography (CT) in the detection of abdominal solid organ injury in young children \< 8 years of age with concern for blunt abdominal trauma.
Detailed description
Abdominal trauma in children can be deadly, but intra-abdominal injuries can be difficult to detect and often lack external signs of injury on physical exam. The current gold standard imaging study is Computed Tomography (CT) with IV contrast, which is associated with radiation exposure. Contrast-enhanced ultrasound is a radiation-free alternative to detect abdominal injuries and has been studied primarily in adults and some older children, but evidence to support its use in young children is needed. This is a prospective study of children less than 8 years of age who are clinically stable and undergoing an abdominal CT with IV contrast as part of their clinical care due to concerns for abdominal trauma. Investigators will compare CEUS results with those obtained by CT. Investigators will additionally include retrospective data of children who underwent both abdominal CT and CEUS as part of clinical care.
Interventions
DRUGContrast-Enhanced Ultrasound using Lumason
Subjects will undergo a contrast enhanced ultrasound (CEUS) during which a standard greyscale abdominal ultrasound is performed first followed by injection of intravenous contrast with Lumason, and completion of contrast-enhanced ultrasound
Sponsors
Children's Hospital of Philadelphia
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 7 Years
Healthy volunteers
Yes
Inclusion criteria
for study CEUS 1. Males or females \< 8 years of age at time of enrollment 2. Clinically stable (defined as not undergoing an emergent surgical procedure in the next hour) 3. Abdominal CT ordered or obtained 4. IV in place
Exclusion criteria
for study CEUS 1. Unable to obtain contrast-enhanced ultrasound within 72 hours after CT 2. History of allergic reaction to Lumason, sulfa-hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol 4000, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na) palmitic acid) 3. Known congenital or acquired heart disease Alternative Inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of Contrast-Enhanced Ultrasound in detection of abdominal solid organ injury in young children <8 years of age | 2 years | To determine the sensitivity of contrast-enhanced ultrasound (CEUS) compared with standard, abdominal Computer Tomography (CT) in the detection of abdominal solid organ injury in young children \< 8 years of age with concern for blunt abdominal trauma. |
| Specificity of Contrast-Enhanced Ultrasound in detection of abdominal solid organ injury in young children <8 years of age | 2 years | To determine the specificity of contrast-enhanced ultrasound (CEUS) compared with standard, abdominal Computer Tomography (CT) in the detection of abdominal solid organ injury in young children \< 8 years of age with concern for blunt abdominal trauma. |
Countries
United States
Outcome results
None listed