Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT03473249
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.
This study is active but is not currently recruiting participants.
0 year–7 year
All sexes
Interventional
Phase 4
Philadelphia, Pennsylvania, 19104, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for study CEUS
Exclusion criteria
for study CEUS
Alternative Inclusion and Exclusion Criteria for children who have undergone or are undergoing CEUS as part of clinical care
Inclusion criteria
Exclusion criteria
None
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
Other names: SonoVue (25 mg under sulfur hexafluoride gas) / Lumason, Sulfur hexafluoride microbubbles for injection, US Patent No. 5,686,060
Time frame: 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.
Time frame: 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.
Children's Hospital of Philadelphia
Other
Clinical Effectiveness of Contrast-Enhanced Ultrasound in the Evaluation of Blunt Abdominal Trauma in Young Children
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