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Risk Stratification and Treatment Decisions in Infantile Hemangioma With Minimal or Arrested Growth (IH-MAGRST)

1 de julio de 2026 actualizado por: Yi Ji, West China Hospital

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.

Descripción general del estudio

Estado

Aún no reclutando

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

150

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Yi Ji, PhD MD
  • Número de teléfono: 862885423453
  • Correo electrónico: jijiyuanyuan@163.com

Ubicaciones de estudio

    • Sichuan
      • Chengdu, Sichuan, Porcelana, 610041
        • West China Hospital of Sichuan University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

Infants aged 12 months or younger who present for their first systematic evaluation at a hemangioma specialty clinic and are clinically diagnosed with either infantile hemangioma with minimal or arrested growth or classic infantile hemangioma. Participants will be enrolled prospectively and followed as two observational cohorts.

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.
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.
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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Proportion of Participants Recommended for Active Management at the Initial Specialist Evaluation
Periodo de tiempo: Baseline (Day 0)
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.
Baseline (Day 0)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Distribution of 2019 American Academy of Pediatrics Infantile Hemangioma Risk Categories at Baseline
Periodo de tiempo: Baseline (Day 0)
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.
Baseline (Day 0)
Hemangioma Severity Scale Total Score at Baseline
Periodo de tiempo: Baseline (Day 0)
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.
Baseline (Day 0)
Distribution of Baseline Hemangioma Severity Scale Categories
Periodo de tiempo: Baseline (Day 0)
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.
Baseline (Day 0)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Publicaciones y enlaces útiles

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Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

20 de junio de 2026

Finalización primaria (Estimado)

30 de diciembre de 2027

Finalización del estudio (Estimado)

30 de marzo de 2028

Fechas de registro del estudio

Enviado por primera vez

21 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

21 de junio de 2026

Publicado por primera vez (Actual)

25 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • RCT20260621

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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