Risk Stratification and Treatment Decisions in Infantile Hemangioma With Minimal or Arrested Growth (IH-MAGRST)
Infantile Hemangioma With Minimal or Arrested Growth Versus Typical Infantile Hemangioma: A Prospective Cohort Study of Risk Stratification and Treatment Decision-Making
Infantile hemangioma with minimal or arrested growth (IH-MAG) is a subtype of infantile hemangioma that shows little or no obvious growth during infancy. Although these lesions may appear less active than classic infantile hemangiomas, some may still be associated with ulceration, functional risk, permanent disfigurement, or structural anomalies.
This prospective observational cohort study will compare infants with IH-MAG and infants with classic infantile hemangioma at their first specialist evaluation. Each participant will undergo routine clinical assessment, standardized photography, risk classification according to the 2019 American Academy of Pediatrics guideline, and Hemangioma Severity Scale scoring. The main outcome is the initial management recommendation after specialist assessment, categorized as active management or treatment versus observation. The study will not assign any treatment. All management recommendations will be made by clinicians according to routine clinical practice and guideline-based assessment.
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
Infantile hemangioma with minimal or arrested growth (IH-MAG) is a distinct clinical subtype of infantile hemangioma characterized by early-onset vascular lesions with minimal or absent proliferative growth. IH-MAG may be mistaken for capillary malformation or other vascular anomalies because of its relatively subtle growth pattern. However, some IH-MAG lesions, particularly segmental lesions or lesions in high-risk anatomic sites, may still be associated with ulceration, functional impairment, permanent disfigurement, or syndromic structural anomalies.
Standardized tools, including the 2019 American Academy of Pediatrics risk classification and the Hemangioma Severity Scale, are widely used to assess risk and severity in infantile hemangioma. Their clinical value has been studied in infantile hemangiomas overall, but their distribution and decision-making value in IH-MAG remain insufficiently defined.
This is a single-center, prospective, observational comparative cohort study. Infants aged 12 months or younger who present for their first systematic evaluation at a hemangioma specialty clinic will be enrolled if they are clinically diagnosed with IH-MAG or classic infantile hemangioma and meet the eligibility criteria. Participants will be assigned to two observational cohorts: an IH-MAG cohort and a classic infantile hemangioma cohort. No treatment will be assigned by the study protocol.
At baseline, demographic information, lesion characteristics, standardized clinical photographs, AAP risk category, Hemangioma Severity Scale score, and the clinician's initial management recommendation will be recorded. The primary outcome is the initial management recommendation after the first specialist assessment, categorized as active management or treatment versus observation. Active management may include topical therapy, systemic therapy, laser therapy, surgery, local treatment, imaging evaluation, specialist referral, or multidisciplinary assessment when clinically indicated. Observation refers to regular follow-up, parental education, photographic monitoring, and risk counseling without active treatment or additional active management at baseline.
Secondary outcomes include the distribution of AAP risk categories, Hemangioma Severity Scale scores, treatment intensity, reasons for treatment recommendation, use of imaging or specialist screening, changes in the management plan during follow-up, and diagnostic reclassification of suspected IH-MAG. Follow-up information will be collected at approximately 1, 3, and 6 months after baseline to document management implementation, lesion changes, complications, treatment adjustment, and diagnostic stability.
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Kontakty i lokalizacje
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Yi Ji, PhD MD
- Numer telefonu: 862885423453
- E-mail: jijiyuanyuan@163.com
Lokalizacje studiów
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Sichuan
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Chengdu, Sichuan, Chiny, 610041
- West China Hospital of Sichuan University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
- Infants clinically diagnosed with infantile hemangioma, including minimal or arrested growth infantile hemangioma and classic infantile hemangioma.
- Participants undergoing their initial specialist evaluation at the study center.
- Age at baseline: from birth to 24 months.
- Sufficient clinical information available for baseline assessment, including lesion location, morphology, size, number of lesions, complications, and treatment recommendation.
- Parents or legal guardians are able to understand the study procedures and provide written informed consent.
Exclusion Criteria:
- Patients with vascular anomalies other than infantile hemangioma, including vascular malformations, congenital hemangioma, kaposiform hemangioendothelioma, pyogenic granuloma, or other vascular tumors.
- Patients with insufficient clinical information to determine the infantile hemangioma subtype, AAP risk category, Hemangioma Severity Scale score, or baseline treatment recommendation.
- Patients who have received systemic pharmacologic treatment, procedural treatment, laser therapy, or surgical treatment for infantile hemangioma before the baseline specialist evaluation.
- Patients with severe comorbidities or unstable medical conditions that may interfere with clinical assessment or follow-up.
- Parents or legal guardians who decline participation or are unable to provide informed consent.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Liczba grup / kohort
Kohorty i interwencje
Grupa / KohortaGrupa / Kohorta |
Interwencja / LeczenieInterwencja / Leczenie |
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IH-MAG Cohort
Infants clinically diagnosed with infantile hemangioma with minimal or arrested growth at the first specialist evaluation.
IH-MAG is defined as an early-onset vascular lesion with minimal or absent proliferative growth, with proliferative components involving less than 25% of the total lesion area.
Participants in this cohort will undergo routine clinical assessment, standardized photography, AAP risk classification, Hemangioma Severity Scale scoring, and follow-up.
No treatment is assigned by the study protocol.
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Participants will undergo routine specialist evaluation, standardized clinical photography, AAP risk classification, Hemangioma Severity Scale scoring, and follow-up data collection.
Initial management recommendations will be made by clinicians according to routine clinical practice and guideline-based assessment.
No treatment is assigned by the study protocol.
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Typical Infantile Hemangioma Cohort
Infants clinically diagnosed with typical infantile hemangioma at the first specialist evaluation who do not meet the diagnostic criteria for infantile hemangioma with minimal or arrested growth.
This cohort may include superficial, deep, mixed, focal, segmental, or multifocal infantile hemangiomas.
Participants will undergo routine clinical assessment, standardized photography, AAP risk classification, Hemangioma Severity Scale scoring, and follow-up.
No treatment is assigned by the study protocol.
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Participants will undergo routine specialist evaluation, standardized clinical photography, AAP risk classification, Hemangioma Severity Scale scoring, and follow-up data collection.
Initial management recommendations will be made by clinicians according to routine clinical practice and guideline-based assessment.
No treatment is assigned by the study protocol.
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Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Proportion of Participants Recommended for Active Management at the Initial Specialist Evaluation
Ramy czasowe: Baseline (Day 0)
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The proportion of participants for whom active management is recommended at baseline, defined as the initial specialist evaluation on Day 0. Active management is defined as any recommendation for pharmacologic treatment, procedural treatment, imaging evaluation, specialist referral, or multidisciplinary assessment based on guideline-based risk assessment.
Observation is defined as scheduled follow-up, parental education, photographic monitoring, and risk counseling without active treatment or additional active evaluation at baseline.
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Baseline (Day 0)
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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Distribution of 2019 American Academy of Pediatrics Infantile Hemangioma Risk Categories at Baseline
Ramy czasowe: Baseline (Day 0)
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The distribution of participants across prespecified risk categories according to the 2019 American Academy of Pediatrics clinical practice guideline for infantile hemangioma.
Participants will be classified as highest risk, high risk, intermediate risk, or low risk based on lesion size, anatomic location, morphology, number of lesions, and risk of complications.
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Baseline (Day 0)
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Hemangioma Severity Scale Total Score at Baseline
Ramy czasowe: Baseline (Day 0)
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The Hemangioma Severity Scale total score at baseline.
The Hemangioma Severity Scale is used to assess the overall clinical severity of infantile hemangioma and includes objective and subjective components, including lesion size, anatomic location, risk of associated structural anomalies, complications, pain, and risk of disfigurement.
The total score ranges from 0 to 51, with higher scores indicating greater hemangioma severity and a worse clinical outcome.
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Baseline (Day 0)
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Distribution of Baseline Hemangioma Severity Scale Categories
Ramy czasowe: Baseline (Day 0)
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The distribution of participants across prespecified Hemangioma Severity Scale categories based on the baseline Hemangioma Severity Scale total score.
The Hemangioma Severity Scale total score ranges from 0 to 51, with higher scores indicating greater hemangioma severity and a worse clinical outcome.
Categories are defined as follows: 5 or lower, 6 to 10, and 11 or higher.
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Baseline (Day 0)
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Współpracownicy i badacze
Sponsor
Sponsor
Publikacje i pomocne linki
Publikacje ogólne
- Suh KY, Frieden IJ. Infantile hemangiomas with minimal or arrested growth: a retrospective case series. Arch Dermatol. 2010 Sep;146(9):971-6. doi: 10.1001/archdermatol.2010.197.
- Haggstrom AN, Beaumont JL, Lai JS, Adams DM, Drolet BA, Frieden IJ, Garzon MC, Holland KE, Horii KA, Lucky AW, Mancini AJ, Metry DW, Morel KD, Newell BD, Nopper AJ, Siegel D, Swigonski NL, Cella D, Chamlin SL. Measuring the severity of infantile hemangiomas: instrument development and reliability. Arch Dermatol. 2012 Feb;148(2):197-202. doi: 10.1001/archdermatol.2011.926.
- Krowchuk DP, Frieden IJ, Mancini AJ, Darrow DH, Blei F, Greene AK, Annam A, Baker CN, Frommelt PC, Hodak A, Pate BM, Pelletier JL, Sandrock D, Weinberg ST, Whelan MA; SUBCOMMITTEE ON THE MANAGEMENT OF INFANTILE HEMANGIOMAS. Clinical Practice Guideline for the Management of Infantile Hemangiomas. Pediatrics. 2019 Jan;143(1):e20183475. doi: 10.1542/peds.2018-3475.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- RCT20260621
Plan dla danych uczestnika indywidualnego (IPD)
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Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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