Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Infantile hemangioma is a benign tumor belonging to the group of vascular tumors in the ISSVA classification (International Society for the Study of Vascular Anomalies). The diagnosis is clinical and radiological. The hemangioma appears during the first weeks of life (70% classically within 2 weeks after birth) but can, when it develops in the subcutaneous tissue, appear until the age of 2 to 3 months .
Its evolution is characteristic and is divided into 3 phases with a proliferative phase characterized by a rapid increase in the size of the tumor (up to 6 to 12 months), a phase of stabilization (from 12 to 36 months) with a stopping of the growth of the hemangioma and a regression of its size and a phase of involution with the disappearance of the lesion which may give way to residual fibroadipose tissue, cutaneous telangiectases, scars … The usual complications of haemangiomas occur during the proliferative phase. It is necrosis, ulcerations that can be complicated by bleeding or infection and eventually indelible scarring. Other complications related to the site of development of hemangiomas (amblyopia, astigmatism, upper respiratory obstruction, nasal obstruction, sphincter disorders, eating disorders), hemangiomas destroying structures noble (breast hypodévelopment, alopecia). The aesthetic prognosis can be seriously compromised for facial locations.
Historically, when drug therapy was required, patient management was based on systemic corticosteroids (at doses of 3 to 5 mg / kg / day) in first-line therapy and vincristine as a second-line failure of corticosteroid therapy or when life-threatening is at stake.
In 2014, the high French health authority (HAS) gave Marketing Authorization for Hemangiol 3.75 mg / ml oral solution for the management of infantile proliferative hemangioma requiring first-line systemic treatment, evaluating the actual benefit as important.
The selected indication concerns children from 5 weeks to 5 months with:
The objective of our study is to describe the use of Hemangiol in current practice in our hospital from 2014 to 2018.
This study is retrospective, longitudinal, descriptive and observational. Children aged 0 to 1 years hospitalized for introduction of Hemangiol between January 2014 and November 2018 will be included. Patients refuse the use of medical data will be excluded.
The main objective is to describe the population who received Hemangiol. The secondary objectives is to evaluate
The following criteria will be collected
Demographic description: age, sex, height, weight
Personal history
Description of the hemangioma:
Rhythm of follow-up: duration of treatment and observance of treatment
Prescribed dose: 1, 2, 3 or 4 mg / kg / day in 2 doses
Evolution of the hemangioma: progression, regression, stagnation. Needed a second medical therapeutic line by specifying the treatment introduced. Necessity of surgical management by specifying the delay between surgery and the introduction of treatment
Description of serious adverse events: hypotension, bradycardia, bronchospasm, hypoglycaemia. Description of other adverse events.
Number of cardio-pediatric consultations, specifying:
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events in children with proliferative infantile hemangiomas receiving Hemangiol |
| 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of the regression of proliferative infantile hemangiomas in children receiving Hemangiol | rate of regression of the hemangioma
| 6 days |
| Incidence of diagnosed heart diseases with systematic cardiac consultation events in children with proliferative infantile hemangiomas receiving Hemangiol |
Not provided
Inclusion criteria:
- Child from 0 to 18 years old hospitalized for introduction of Hemangiol between January 2014 and November 2018
Exclusion criteria:
- Patients refuse the use of medical data will be excluded.
Not provided
Not provided
Not provided
Children aged 0 to 1 years hospitalized for introduction of Hemangiol for proliferative infantile hemangiomas.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Arthur GAVOTTO, MD | University Hospital, Montpellier | Principal Investigator |
| Pascal AMEDRO, MD, PhD | University Hospital, Montpellier | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uh Montpellier | Montpellier | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33118199 | Result | Socchi F, Bigorre M, Normandin M, Captier G, Bessis D, Mondain M, Blanchet C, Akkari M, Amedro P, Gavotto A. Hemangiol in infantile haemangioma: A paediatric post-marketing surveillance drug study. Br J Clin Pharmacol. 2021 Apr;87(4):1970-1980. doi: 10.1111/bcp.14593. Epub 2020 Nov 16. |
Not provided
Not provided
NC
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018324 | Hemangioma, Capillary |
| ID | Term |
|---|---|
| D006391 | Hemangioma |
| D009383 | Neoplasms, Vascular Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
rate of diagnosed heart disease |
| 3 days |