Risk Stratification and Treatment Decisions in Infantile Hemangioma With Minimal or Arrested Growth

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-12
SponsorWest China Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Routine Clinical Assessment and Risk Stratification

    Other intervention

    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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: IH-MAG Cohort1 intervention
Group B: Typical Infantile Hemangioma Cohort1 intervention

Trial outcomes

Primary outcomes

1

Proportion of Participants Recommended for Active Management at the Initial Specialist Evaluation

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.

Time frame
Baseline (Day 0)

Secondary outcomes

1

Distribution of 2019 American Academy of Pediatrics Infantile Hemangioma Risk Categories at Baseline

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.

Time frame
Baseline (Day 0)
2

Hemangioma Severity Scale Total Score at Baseline

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.

Time frame
Baseline (Day 0)
3

Distribution of Baseline Hemangioma Severity Scale Categories

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.

Time frame
Baseline (Day 0)

Other outcomes

Sponsors and contacts

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