Hemangioma
Conditions
Keywords
prospective cohort study
Brief summary
This study will attempt to determine how common liver hemangiomas are in children with infantile hemangiomas by comparing liver ultrasound results in patients with 1-4 cutaneous hemangiomas, 5 or more cutaneous hemangiomas, or at least 1 large hemangioma versus ultrasound results in children without hemangiomas. Other objectives of the study include identifying specific risk factors in patients who have liver hemangiomas and identifying risk factors in children with symptomatic liver hemangiomas.
Detailed description
Hemangioma of infancy is the most common tumor of childhood occurring in 4% to 10% of infants. While most hemangiomas are benign in behavior and involute spontaneously, some can cause significant morbidity due to their location and size. In addition, some hemangiomas may be associated with extracutaneous hemangiomas that result in significant morbidity. Certain high risk hemangiomas of infancy, specifically multiple cutaneous hemangiomas or a solitary large hemangioma, have been associated with hepatic hemangiomatosis; however, the exact number or size of the cutaneous lesions at which the risk increases and the protocol for evaluating these patients remain controversial. The true prevalence of hepatic hemangiomatosis is unknown since there have been no large scale prospective studies evaluating clinically asymptomatic patients with cutaneous hemangiomas for the presence of hepatic hemangiomatosis. One of the primary objectives of this study is to determine the incidence of hepatic hemangiomatosis in patients with hemangiomas of infancy by comparing hepatic ultrasound imaging results of patients with 1-4 cutaneous hemangiomas, 5 or more cutaneous hemangiomas, or at least 1 large hemangioma \>30 cm2 versus imaging results in patients without cutaneous hemangiomas. The study will also attempt to identify specific risk factors associated with the development of hepatic hemangiomatosis and to identify associated risk factors in patients with clinically symptomatic hepatic hemangiomatosis.
Interventions
PROCEDUREabdominal ultrasound
abdominal ultrasound to detect hepatic hemangiomas
OTHERDermatologic Examination
Complete dermatologic examination
Sponsors
Medical College of Wisconsin
University of California, San Francisco
Columbia University
Baylor College of Medicine
Northwestern University
St. Justine's Hospital
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Children's Mercy Hospital Kansas City
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No
Inclusion criteria
* Infants less than 6 months of age * clinical diagnosis of 1-4 cutaneous hemangiomas * clinical diagnosis of 5 or more cutaneous hemangiomas * clinical diagnosis of at least 1 large cutaneous hemangioma greater than 30 cm2
Exclusion criteria
* Infants greater than 6 months of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Hepatic Hemangiomas Identified on Abdominal Ultrasound | 2 years | The number of participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least one large cutaneous hemangioma) who were found to have hepatic hemangiomas on abdominal ultrasound |
| Presence of Hepatic Hemangiomas on Abdominal Ultrasound | 2 years | The number of participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least one large cutaneous hemangioma) who were found to have hepatic hemangiomas on abdominal ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk Factors Associated With the Development of Hepatic Hemangiomas | 2 years | Which participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least 1 large cutaneous hemangioma) were found to have hepatic hemangiomas on abdominal ultrasound |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Cutaneous Hemangiomas (multiple \> 5, 1-4, or at least 1 hemangioms \>30 cm2) | 261 |
| Total | 261 |
Baseline characteristics
| Characteristic | Group 1 |
|---|---|
| Age, Categorical <=18 years | 261 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age Continuous | 0.3 years STANDARD_DEVIATION 0.1 |
| Region of Enrollment Canada | 16 participants |
| Region of Enrollment Spain | 13 participants |
| Region of Enrollment United States | 232 participants |
| Sex: Female, Male Female | 192 Participants |
| Sex: Female, Male Male | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 261 |
| serious Total, serious adverse events | 0 / 261 |
Outcome results
Primary
Frequency of Hepatic Hemangiomas Identified on Abdominal Ultrasound
The number of participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least one large cutaneous hemangioma) who were found to have hepatic hemangiomas on abdominal ultrasound
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Frequency of Hepatic Hemangiomas Identified on Abdominal Ultrasound | 24 participants |
Primary
Presence of Hepatic Hemangiomas on Abdominal Ultrasound
The number of participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least one large cutaneous hemangioma) who were found to have hepatic hemangiomas on abdominal ultrasound
Time frame: 2 years
Secondary
Risk Factors Associated With the Development of Hepatic Hemangiomas
Which participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least 1 large cutaneous hemangioma) were found to have hepatic hemangiomas on abdominal ultrasound
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Risk Factors Associated With the Development of Hepatic Hemangiomas | 24 participants |