Infantile Hemangioma With Minimal or Arrested Growth : Epidemiology, Clinical Characteristics and Evolution

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Completed
CT.gov ID
NCT05080868
Collaborator
(none)
224
1
4.8
47

Study Details

Study Description

Brief Summary

Infantile hemangioma (IH) is the most common vascular tumor of infancy, characterized by its clinical history. Absent at birth or present under the form of a premonitory mark, they display a rapid proliferative phase starting in the first weeks of life. Then, after a plateau phase, they slowly involute. However, a subtype of IH named "abortive", "minimal or arrested growth", "reticular" or "telangiectatic" hemangioma differs from typical IH because it doesn't have a proliferative component, or only a minimal one. This subtype of hemangioma has been recently described and data are lacking regarding its proportion among infantile hemangioma and its differences with "classic" infantile hemangioma. The aim of this study is to estimate the proportion of abortive hemangioma among infantile hemangioma. Also, the investigators aim to compare the clinical characteristics of "classic" infantile hemangiomas and abortive hemangiomas. Lastly, investigators wished to study the evolution of abortive hemangioma.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    224 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Comparing Epidemiological and Clinical Characteristics of Infantile Hemangioma With Minimal or Arrested Growth (IH-MAG) and Classic Infantile Hemangioma : a Retrospective Study
    Actual Study Start Date :
    Mar 23, 2021
    Actual Primary Completion Date :
    May 30, 2021
    Actual Study Completion Date :
    Aug 15, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Infantile hemangioma with minimal or arrested growth

    Epidemiological and clinical characteristics of infantile hemangioma with minimal or arrested growth.

    Classic infantile hemangioma

    Epidemiological and clinical characteristics of classic infantile hemangioma.

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of abortive hemangioma among infantile hemangioma [baseline]

      Proportion of abortive hemangioma among infantile hemangioma

    Secondary Outcome Measures

    1. To compare the epidemiological characteristics between infantile hemangioma and abortive hemangioma : sex [baseline]

      Compare sex predominance between infantile hemangioma and abortive hemangioma

    2. To compare the epidemiological characteristics between infantile hemangiomas and abortive hemangiomas : prematurity [baseline]

      Compare prematurity rates between infantile hemangiomas and abortive hemangiomas

    3. To compare the epidemiological characteristics between infantile hemangiomas and abortive hemangiomas : birthweight [baseline]

      Compare birthweight between infantile hemangiomas and abortive hemangiomas

    4. To compare the clinical characteristics between infantile hemangiomas and abortive hemangiomas : localization [baseline]

      Compare localization between infantile hemangiomas and abortive hemangiomas

    5. To compare the clinical characteristics between infantile hemangiomas and abortive hemangiomas : treatment [baseline]

      le hemangiomas and abortive hemangiomaCompare treatment between infanti

    6. To compare the clinical characteristics between infantile hemangiomas and abortive hemangiomas : complications [baseline]

      Compare complications between infantile hemangiomas and abortive hemangioma

    7. To compare the clinical characteristics between infantile hemangiomas and abortive hemangiomas : size [baseline]

      Compare size (focal, extended or segmental) between infantile hemangiomas and abortive hemangioma

    8. To study the evolution of abortive hemangioma : erythematous macule [through study completion, an average of 4 years]

      Evaluation of the fading of erythematous macule between the stage of maximal proliferation and the last follow-up

    9. To study the evolution of abortive hemangioma : papules of proliferation [through study completion, an average of 4 years]

      Evaluation of the regression of the papules of proliferation between the stage of maximal proliferation and the last follow-up

    10. To study the evolution of abortive hemangioma : telangiectasias [through study completion, an average of 4 years]

      Evaluation of the fading of telangiectasias between the stage of maximal proliferation and the last follow-up

    11. To study the evolution of abortive hemangioma : halo of vasoconstriction [through study completion, an average of 4 years]

      Evaluation of the fading of the vasoconstricted halo between the stage of maximal proliferation and the last follow-up

    12. To study the evolution of abortive hemangioma : areas of vasoconstriction [through study completion, an average of 4 years]

      Evaluation of the fading of vasoconstricted areas between the stage of maximal proliferation and the last follow-up

    13. To study the evolution of abortive hemangioma : dilated veins [through study completion, an average of 4 years]

      Evaluation of the fading of dilated veins between the stage of maximal proliferation and the last follow-up

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Children between 0 and 18 years old

    • Followed in the dermatology department of CHRU de Nancy between January 2014 and December 2020

    • Presenting with one or more infantile hemangioma

    Exclusion Criteria:
    • Those whoes guardian does not want his data to be collected in this study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU de Nancy Nancy Grand-Est France 54000

    Sponsors and Collaborators

    • Central Hospital, Nancy, France

    Investigators

    • Study Director: BURSZTEJN Anne-Claire, MD, PhD, Central Hospital, Nancy, France

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Central Hospital, Nancy, France
    ClinicalTrials.gov Identifier:
    NCT05080868
    Other Study ID Numbers:
    • 2019PI221
    First Posted:
    Oct 18, 2021
    Last Update Posted:
    Oct 18, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 18, 2021